Nitrile Gloves CDSCO Registration — MD-5 & MD-15 License Complete Guide

Nitrile examination and surgical gloves are among the highest-volume, most ubiquitous medical devices in healthcare delivery worldwide — used in virtually every clinical encounter, surgical procedure, diagnostic test, and infection control protocol across India’s healthcare system. As single-use, sterile or non-sterile, patient-contacting and bodily-fluid-barrier devices manufactured and consumed in extraordinarily high volumes, nitrile gloves are subject to mandatory CDSCO regulation under the Medical Devices Rules, 2017 (MDR 2017) — a requirement that gained heightened market and regulatory attention following the dramatic global surge in glove demand and trade during the COVID-19 pandemic.

Whether you are a foreign manufacturer (particularly from Malaysia, Thailand, China, or Vietnam — the world’s leading nitrile glove production hubs) seeking to export to India, an Indian importer or distributor of international glove brands, or a domestic manufacturer establishing nitrile glove production in India, CDSCO registration is a mandatory legal requirement. Importing, manufacturing, distributing, or selling nitrile gloves without a valid CDSCO licence is a criminal offence under the Drugs and Cosmetics Act, 1940.

We provide complete CDSCO registration services for nitrile gloves — covering both the import licence pathway (Form MD-14 / MD-15) and the manufacturing licence pathway (Form MD-5 / MD-6) — with end-to-end expert support from device classification through licence issuance and ongoing post-market compliance.

What is CDSCO Registration for Nitrile Gloves?

CDSCO registration is the formal process through which the Central Drugs Standard Control Organisation (CDSCO), functioning under the Ministry of Health and Family Welfare, Government of India, evaluates nitrile gloves and grants a Market Authorisation (Medical Device Licence) permitting their commercial manufacture or import for sale in India.

All applications are filed through the CDSCO SUGAM online portal (sugam.gov.in):

• Form MD-14 — Application for Import Licence (for gloves manufactured outside India)
• Form MD-5 — Application for Manufacturing Licence (for gloves manufactured in India)

Upon successful evaluation and approval:

• Form MD-15 — Import Licence is issued
• Form MD-6 — Manufacturing Licence is issued

Both licence types are device-specific, manufacturer-specific, and valid for 5 years from the date of issue.

Why Nitrile Gloves Specifically — Understanding the Material and Device Category

Nitrile (NBR — nitrile butadiene rubber) is a synthetic rubber material widely adopted as the preferred alternative to natural rubber latex gloves, given the absence of natural rubber latex proteins responsible for Type I latex allergy reactions — a significant clinical and occupational health consideration given the high prevalence of latex sensitisation among healthcare workers and patients with repeated glove exposure. Nitrile also offers superior puncture resistance and chemical resistance compared to natural latex in many applications, making it the material of choice for an increasing share of the global medical glove market.

Nitrile Glove Types Covered Under CDSCO Registration

Examination Gloves (Non-Sterile) The highest-volume category — single-use, non-sterile gloves used for general patient examination, routine clinical procedures, and infection control across hospitals, clinics, diagnostic labs, and ambulatory care settings. Typically supplied in bulk dispenser boxes.

Surgical Gloves (Sterile) Sterile nitrile gloves designed for use during surgical procedures, requiring a higher standard of fit, tactile sensitivity, and sterility assurance compared to examination gloves. Individually packaged and sterilised, typically following anatomically shaped, sized fitting (with distinct left/right hand fit in many designs).

Powdered vs. Powder-Free Gloves Historically, gloves were powdered (typically with cornstarch) to ease donning. Powder-free gloves have become the overwhelming global standard due to concerns regarding powder-related complications (granuloma formation, wound healing interference, and powder acting as a carrier for latex allergens in latex gloves). Most modern nitrile glove regulatory submissions are for powder-free products.

Chemotherapy-Rated Gloves Specialised nitrile gloves tested and validated for resistance to permeation by cytotoxic/chemotherapy drugs — used in oncology pharmacy compounding and chemotherapy administration, where standard examination glove protection is insufficient.

Extended Cuff / Gauntlet Gloves Longer-cuffed nitrile gloves providing extended forearm coverage — used in specific clinical and laboratory contexts requiring greater splash/contamination protection.

Textured vs. Smooth Finish Gloves A design/manufacturing variation affecting grip and tactile performance — generally not affecting the fundamental regulatory pathway but relevant to technical specification documentation.

Coloured and Specialty Gloves Gloves manufactured in various colours (blue, purple, black, etc.) for visual differentiation, workflow management, or branding purposes — the colourant/pigment formulation requires its own biocompatibility consideration within the overall device assessment.

Regulatory Classification of Nitrile Gloves Under MDR 2017

Classification note: Non-sterile nitrile examination gloves are generally classified as Class A — the lowest risk category under MDR 2017 — reflecting their non-invasive, non-sterile, external-use nature. Sterile surgical gloves, given their use directly within the surgical field and the sterility assurance requirements involved, are typically classified as Class B. This classification distinction has significant practical implications: examination glove manufacturing licences are issued by the State Licensing Authority, not CDSCO centrally, while surgical glove registrations (and all imports, regardless of class) proceed through the CDSCO SUGAM portal. Our regulatory team conducts a formal, device-specific classification analysis for every application to confirm the correct pathway.

Why Nitrile Gloves Receive Particular Regulatory and Market Attention

Post-Pandemic Regulatory Scrutiny The COVID-19 pandemic’s unprecedented surge in global glove demand led to a corresponding surge in new manufacturers, new import sources, and — significantly — substandard and counterfeit products entering global supply chains. This has resulted in heightened regulatory vigilance specifically around glove quality, testing documentation, and registration compliance in India and globally.

Extremely High Volume, Commodity-Level Trade Gloves are traded in enormous volumes (often measured in hundreds of millions to billions of units annually for established importers/manufacturers) at relatively low per-unit prices — creating a market dynamic where even small percentage quality defect rates translate into very large absolute numbers of substandard products reaching end users.

Barrier Performance is the Core Safety Claim Unlike many medical devices where safety relates to mechanical or electrical performance, a glove’s entire safety value proposition rests on its barrier integrity — its ability to prevent pathogen and fluid transmission. This makes pinhole/leak testing and barrier performance documentation the single most safety-critical aspect of glove regulatory submissions.

AQL (Acceptable Quality Level) as a Defining Quality Metric Glove quality is conventionally and specifically measured using AQL (Acceptable Quality Level) sampling — a statistical quality control method defining the maximum acceptable percentage of defective units (primarily pinholes) in a given production batch. AQL 1.5 is a common benchmark for examination gloves; surgical gloves typically require a stricter AQL (e.g., AQL 1.0 or better).

Who Needs CDSCO Nitrile Glove Registration?

• Foreign manufacturers — particularly from Malaysia (home to several of the world’s largest glove manufacturers), Thailand, China, Vietnam, and Indonesia — exporting nitrile gloves to India, who must appoint an Indian Authorised Agent (IAA) to file the import licence application
• Indian importers and distributors of international nitrile glove brands
• Domestic manufacturers establishing or operating nitrile glove production facilities in India — a growing segment given India’s strategic interest in reducing import dependency for critical PPE
• Hospital and healthcare supply distributors supplying gloves in bulk to hospitals, clinics, and diagnostic centres
• Government procurement and tender suppliers — supplying gloves through GeM, state health department tenders, and institutional/government hospital procurement
• Industrial and laboratory supply distributors — where products are specifically marketed and intended for medical/clinical use (industrial-grade gloves not marketed for medical use fall outside MDR 2017’s scope, but this distinction must be carefully and accurately maintained in marketing and labelling)
• E-commerce sellers distributing medical-grade gloves through online platforms

Complete Document Checklist for Nitrile Glove CDSCO Registration

SECTION A — Indian Applicant / IAA Documents

1. Application in Form MD-14 (Import) or Form MD-5 (Manufacturing) Accurately completed application filed through the CDSCO SUGAM portal (or with the State Licensing Authority for Class A examination gloves manufactured domestically) with correct applicant, manufacturer, and product details.

2. Business Registration Certificate Certificate of Incorporation, Partnership Deed, LLP Agreement, or equivalent proof of the Indian entity’s legal existence.

3. Import Export Code (IEC) Valid IEC from DGFT — mandatory prerequisite for import licence applications, particularly relevant given that the large majority of India’s nitrile glove supply (especially surgical-grade) continues to be imported from established Southeast Asian manufacturing hubs.

4. GST Registration Certificate Valid GSTIN of the applicant entity.

5. Authorisation Letter from Foreign Manufacturer Formally notarised and apostilled letter from the overseas manufacturer appointing the Indian entity as Indian Authorised Agent (IAA), explicitly listing all glove product codes/SKUs (covering size ranges, sterile/non-sterile variants, and colour variants) covered.

6. Indian Authorised Agent (IAA) Agreement Formal agreement defining the IAA’s regulatory responsibilities under MDR 2017 in India.

7. Affidavit / Undertaking by Indian Applicant Sworn affidavit by proprietor / directors declaring compliance with MDR 2017 and accuracy of all submitted information.

8. Power of Attorney (if filing through regulatory consultant) Duly executed POA authorising the consultant to file and manage the application.

SECTION B — Device Technical Documents

9. Device Description and Intended Use Comprehensive document covering:

• Full product name, catalogue/model number(s), and all variants in the application (sizes — typically XS through XL, sterile/non-sterile, powdered/powder-free, coloured variants, chemotherapy-rated where applicable)
• Material composition — nitrile (NBR) polymer formulation, including any accelerators, stabilisers, and colourants
• Intended use — examination/diagnostic use, surgical use, or chemotherapy handling
• Intended clinical environment and users — clinicians, nurses, laboratory personnel, pharmacy compounding staff (for chemotherapy-rated products)
• Manufacturing process overview — dipping/forming process, vulcanisation, leaching, chlorination/polymer coating (for donning ease), packaging

10. Technical Specifications Detailed performance specifications including:

• Dimensional specifications — length, width, thickness (typically specified at the palm, finger, and cuff) per size
• Tensile strength (before and after accelerated ageing) — a key mechanical performance indicator for material integrity over shelf life
• Elongation at break
• AQL (Acceptable Quality Level) for the product — typically AQL 1.5 for examination gloves, AQL 1.0 or stricter for surgical gloves
• Watertight/leak test methodology and pass criteria
• For chemotherapy-rated products — permeation resistance data against specified cytotoxic drug panels
• Sterilisation method and parameters (for sterile surgical gloves) — typically ethylene oxide (ETO) or gamma irradiation
• Shelf life and expiry basis

11. Essential Principles Checklist (Schedule III — MDR 2017) Demonstration of how the nitrile glove satisfies each applicable Essential Principle of Safety and Performance under Schedule III of MDR 2017 — with references to standards, test reports, and technical evidence.

12. Risk Management File (ISO 14971:2019) Complete risk management documentation covering:

• Risk management plan
• Hazard identification specific to medical gloves:
  • Barrier failure (pinholes, tears) leading to cross-contamination or infection transmission
  • Chemical sensitisation from accelerators or other formulation chemicals (Type IV allergic contact dermatitis — a recognised concern even with latex-free nitrile gloves, given the chemical accelerators used in nitrile formulation)
  • Inadequate fit leading to reduced tactile sensitivity or dexterity (a clinical performance concern, particularly for surgical use)
  • Degradation during use when exposed to certain chemicals or pharmaceutical agents not covered by the product’s intended use claims
  • Non-sterility (for surgical gloves) leading to surgical site infection
  • Powder-related complications (for powdered variants, where still manufactured/sold)
• Risk estimation and evaluation for each hazard
• Risk control measures and verification of effectiveness
• Residual risk assessment

13. Biocompatibility Documentation (ISO 10993 Series) For nitrile gloves, given direct, often prolonged, skin contact (and surgical gloves’ use within the sterile surgical field):

• Cytotoxicity (ISO 10993-5)
• Sensitisation (ISO 10993-10 / ISO 10993-23) — particularly important given the recognised potential for Type IV chemical sensitisation to nitrile glove accelerator chemicals, even in the absence of natural rubber latex protein
• Irritation (ISO 10993-23)
• Additional endpoints may be required based on the specific contact duration classification (limited contact, given typical single-use, relatively short-duration wear) per the ISO 10993-1 risk-based framework

14. Sterilisation Validation Documentation (for sterile surgical gloves)

• Sterilisation method validation per ISO 11135 (for ETO sterilisation) or ISO 11137 (for radiation sterilisation)
• Sterility Assurance Level (SAL) achievement data (10⁻⁶)
• For ETO-sterilised products — residual ETO and ethylene chlorohydrin (ECH) levels per ISO 10993-7

15. Packaging Validation (for sterile products) Documentation per ISO 11607 demonstrating that sterile barrier packaging maintains sterility under expected storage, handling, and transport conditions, including seal integrity and shelf-life support data.

SECTION C — Test Reports and Standards Compliance

All test reports must be issued by NABL-accredited laboratories or internationally accredited laboratories (ILAC MRA members).

16. ASTM D6319 — Standard Specification for Nitrile Examination Gloves for Medical Application A widely referenced international standard specifically for nitrile examination gloves, covering dimensional requirements, physical property requirements (tensile strength, elongation), and freedom from holes (AQL-based testing). Often used alongside or as a reference standard supporting the ISO equivalents below.

17. ISO 11193-1 — Single-Use Medical Examination Gloves — Specification for Gloves Made from Rubber Latex or Rubber Solution The primary international standard for medical examination gloves (covering nitrile and other synthetic/natural rubber materials), specifying requirements for dimensions, physical properties (tensile strength, elongation at break, before and after accelerated ageing), and freedom from holes via the AQL-based watertight test method.

18. ISO 11193-2 — Specification for Gloves Made from Polyvinyl Chloride or Polyurethane Relevant if your product portfolio includes non-nitrile synthetic examination gloves alongside nitrile products, for comparative documentation purposes.

19. ASTM D6124 — Standard Test Method for Residual Powder on Medical Gloves Applicable for powdered glove variants — testing residual powder content. For powder-free products, demonstrating compliance with applicable low-powder/powder-free criteria is relevant.

20. ISO 10282 — Single-Use Sterile Rubber Surgical Gloves — Specification The primary product-specific standard for sterile surgical gloves — specifying dimensional, physical property, and freedom-from-holes (AQL) requirements specific to the surgical glove category, generally with stricter performance criteria than examination glove standards given the surgical use context.

21. EN 374 Series / ISO 374 Series — Protective Gloves Against Dangerous Chemicals and Micro-organisms (where chemotherapy/chemical-resistance claims are made) For chemotherapy-rated or chemical-resistant glove claims, permeation resistance testing against specified chemical/drug panels per the applicable parts of this standard series.

22. ISO 11135 / ISO 11137 — Sterilization Validation (for sterile products)

23. ISO 11607 — Sterile Packaging Validation (for sterile products)

24. ISO 10993 Series — Biological Evaluation

25. AQL Sampling and Testing Protocol Documentation Documented batch sampling and AQL testing protocol — demonstrating the statistical sampling methodology used to verify each production batch meets the claimed AQL specification before release.

SECTION D — Quality Management System Documents

26. ISO 13485:2016 Certificate Valid ISO 13485 QMS certificate from an accredited certification body — scope must explicitly cover medical gloves or examination/surgical glove manufacturing.

27. QMS Overview Summary of the manufacturer’s quality management system, with particular attention to batch-wise AQL testing and release procedures given the device category’s reliance on statistical quality control.

28. Post-Market Surveillance (PMS) Plan Documented plan for collecting and reviewing real-world performance and complaint data — particularly relevant given the high-volume nature of this category and the post-pandemic regulatory focus on glove quality.

29. Vigilance Procedures Procedures for detecting and reporting serious incidents — including barrier failure complaints, allergic reaction reports, or batch quality failures identified post-market.

30. Batch Release Testing Procedures Detailed documentation of the AQL-based batch sampling, testing, and release decision process applied to every production/import batch before market release.

SECTION E — Labelling and Instructions for Use

31. Device Label (Schedule V — MDR 2017) Compliant label for the product packaging (typically the dispenser box for examination gloves, or individual sterile pouch plus shelf carton for surgical gloves) including:

• Product name and catalogue/model number
• Manufacturer’s name and address
• Country of manufacture
• IAA’s name and address
• UDI (GTIN, lot/batch number)
• Manufacturing date and expiry date
• Size designation
• “STERILE” designation and sterilisation method symbol (for surgical gloves)
• “Single Use Only” designation
• “Natural Rubber Latex Free” or equivalent material composition statement (an important claim for nitrile products, given the latex-allergy differentiation that is often the primary commercial rationale for nitrile selection)
• Powder-free designation (where applicable)
• Applicable ISO 15223 symbols

32. Instructions for Use (IFU) / Labelling Insert Documentation covering:

• Intended use
• Donning instructions
• Single-use/no-reuse warning
• Storage conditions
• Disposal guidance (biomedical waste handling per applicable regulations)
• For chemotherapy-rated products — specific guidance on validated chemical/drug compatibility and permeation breakthrough time limitations

SECTION F — Documents from Foreign Manufacturer (Import Applications)

33. Free Sale Certificate (FSC) / Market Authorisation From the competent authority in the manufacturer’s home country — commonly including:

• Malaysia: Medical Device Authority (MDA) registration — Malaysia being the world’s largest glove manufacturing base
• USA: FDA 510(k) clearance
• European Union: CE Certificate under EU MDR 2017/745 or applicable PPE Regulation (for certain glove categories) from a Notified Body
• Thailand: Thai FDA registration

Must be apostilled / legalised by the Indian Embassy.

34. Manufacturing Licence of Foreign Facility Proof of manufacturing site authorisation, including evidence of GMP-compliant manufacturing environment.

35. GMP Compliance Certificate ISO 13485 certificate or equivalent.

36. Site Master File (SMF) Comprehensive manufacturing facility description, including dipping line capacity, quality control laboratory capabilities, and AQL testing infrastructure.

37. Declaration of Conformity Formal manufacturer declaration of MDR 2017 conformity and Essential Principles compliance.

38. Batch-Wise Test Certificates (Certificate of Analysis / Certificate of Conformance) Given the commodity, high-volume nature of glove trade, batch-specific test certificates demonstrating AQL compliance for the specific production lots being imported are commonly required and expected as part of ongoing import documentation, supplementing the product-level registration dossier.

Step-by-Step CDSCO Registration Process for Nitrile Gloves

Step 1 — Free Regulatory Assessment and Classification

Our team reviews your glove product’s specifications (sterile/non-sterile, examination/surgical, chemotherapy-rated) to determine the correct MDR 2017 classification and registration pathway — State Licensing Authority (Class A examination gloves) or CDSCO centrally (Class B surgical gloves and all imports).

Step 2 — Documentation Gap Analysis

We systematically compare available documents against CDSCO requirements — identifying missing AQL test data, biocompatibility gaps, or sterilisation validation deficiencies.

Step 3 — Standards Compliance Review

We specifically verify compliance with ISO 11193-1 (examination gloves) or ISO 10282 (surgical gloves), confirming all dimensional, physical property, and AQL requirements are addressed with current, batch-representative test data.

Step 4 — Biocompatibility and Sensitisation Documentation Review

Given the recognised potential for chemical sensitisation to nitrile accelerator chemicals, we ensure sensitisation testing (ISO 10993-10) is robust and clearly documented.

Step 5 — Foreign Manufacturer Document Coordination

We coordinate with the overseas manufacturer (frequently based in Malaysia, Thailand, or other major glove-producing countries) to obtain FSC, SMF, ISO 13485 certificate, Declaration of Conformity, and apostille/legalisation of foreign documents.

Step 6 — Technical Dossier Preparation

We prepare or review the complete dossier — Essential Principles Checklist, Risk Management File, biocompatibility summary, and labelling review.

Step 7 — SUGAM Portal / State Licensing Authority Application Filing

We manage the appropriate application channel based on classification — SUGAM portal for CDSCO applications, or the relevant State Licensing Authority for Class A examination glove manufacturing licences.

Step 8 — CDSCO Query Response

Our regulatory experts prepare technically precise, well-documented written responses to all CDSCO queries.

Step 9 — Premises Inspection Support (Manufacturing Licence)

For domestic manufacturing licence applications, we prepare your facility — including dipping line, vulcanisation, leaching, and packaging areas, plus the QC laboratory’s AQL testing capability — for regulatory inspection.

Step 10 — Licence Issuance and Post-Licence Onboarding

Upon approval, we deliver the MD-15 or MD-6 (or State Licensing Authority equivalent) licence with a complete post-licence compliance briefing.

Government Fee for Nitrile Glove CDSCO Registration

Government fees are paid online through the SUGAM portal (or relevant state portal) and are subject to revision.

Estimated Timeline for Nitrile Glove CDSCO Registration

Timelines depend on documentation completeness — particularly AQL test data and biocompatibility documentation — and query resolution speed.

Post-Registration Compliance Obligations

Label Compliance Every glove product packaging unit sold in India must bear a compliant label with manufacturer/IAA details, UDI, sterility designation (where applicable), size, and material composition statement.

Batch-Wise AQL Testing Ongoing batch release testing must be maintained and documented for every production/import lot — a continuous obligation given the AQL-based quality assurance approach fundamental to this device category.

Vigilance Reporting Serious incidents — barrier failure complaints linked to infection transmission, significant allergic reaction reports, batch quality failures — must be reported to CDSCO within prescribed timeframes.

Renewal Licences are valid for 5 years and must be renewed before expiry.

Common Reasons for Application Delay or Rejection

Missing or inadequate AQL test data Generic claims of AQL compliance without batch-representative statistical testing documentation per ISO 11193-1 or ISO 10282 methodology.

Inadequate sensitisation testing Underestimating the regulatory expectation for thorough Type IV sensitisation (ISO 10993-10) testing specific to nitrile accelerator chemical formulations.

“Latex-Free” labelling without adequate substantiation Material composition claims not adequately supported by formulation documentation and, where relevant, residual protein/chemical testing.

Incomplete sterilisation validation for surgical gloves Missing or outdated ISO 11135/11137 validation data, or ISO 10993-7 ETO residual testing.

Mismatched classification application Filing a Class A examination glove application through CDSCO centrally rather than the correct State Licensing Authority pathway (or vice versa for products that are actually Class B), causing procedural delays.

Why Choose Our CDSCO Registration Services for Nitrile Gloves?

High-Volume Disposable PPE/Device Specialisation We have specific experience registering nitrile and other medical glove products with CDSCO — understanding the AQL-based quality framework and extensive standards landscape unique to this device category.

ISO 11193, ISO 10282, and ASTM D6319 Expertise Deep familiarity with the primary glove performance standards, ensuring comprehensive standards compliance documentation for both examination and surgical glove registrations.

Southeast Asian Manufacturer Coordination Experience Given that the world’s major nitrile glove manufacturing is concentrated in Malaysia, Thailand, and neighbouring countries, we have specific experience coordinating documentation, FSC authentication, and apostille processes with manufacturers and regulatory authorities in this region.

Sensitisation and Biocompatibility Expertise We provide specialised guidance on the nuanced biocompatibility and chemical sensitisation documentation requirements particular to nitrile glove formulations.

End-to-End Accountability From free initial assessment through licence issuance and ongoing post-market compliance — complete, accountable service throughout the registration lifecycle.

Frequently Asked Questions 

Q1. Are all nitrile gloves regulated as medical devices in India, or only those marketed for clinical use? 

Only gloves that are marketed, labelled, or intended for medical/clinical use fall under MDR 2017’s regulatory scope. Industrial-grade nitrile gloves marketed for non-medical purposes (general industrial handling, food service, automotive use) are not regulated as medical devices — but any product labelled, marketed, or sold with claims suggesting medical/clinical suitability is squarely within CDSCO’s regulatory ambit, regardless of how it may be positioned elsewhere.

Q2. What is the difference in registration pathway between examination gloves and surgical gloves? 

Non-sterile examination gloves are typically Class A devices, with manufacturing licences issued by the State Licensing Authority rather than CDSCO centrally. Sterile surgical gloves are typically Class B, registered through CDSCO via the SUGAM portal. All imports — regardless of class — are processed through CDSCO centrally via Form MD-14/MD-15.

Q3. What does “AQL 1.5” mean and why does it matter for CDSCO registration? 

AQL (Acceptable Quality Level) 1.5 means that, under the defined statistical sampling protocol, a maximum of 1.5% of units in a sampled batch may exhibit defects (primarily pinholes/leaks) for the batch to be considered acceptable. This is the most fundamental quality metric for medical gloves, and your CDSCO dossier must include test data demonstrating your product reliably meets its claimed AQL specification.

Q4. Can “latex-free” claims on nitrile gloves be made without specific testing? 

While nitrile is inherently free of natural rubber latex proteins (being a synthetic polymer), substantiating a “latex-free” label claim with appropriate documentation — confirming the formulation does not include natural rubber latex components — is expected as part of a complete, defensible regulatory submission, particularly given that latex-free positioning is often the primary commercial differentiator driving nitrile glove selection.

Q5. Is CE marking sufficient to sell nitrile gloves in India? 

No. CE certification documents are submitted as the Free Sale Certificate (FSC) supporting the CDSCO import licence application but do not substitute for a separate Indian CDSCO registration.

Q6. Do chemotherapy-rated gloves require additional documentation beyond standard examination/surgical glove requirements? 

Yes. Chemotherapy-rated gloves require permeation resistance test data against a specified panel of cytotoxic drugs (per applicable EN 374/ISO 374 series testing), in addition to the standard dimensional, physical property, AQL, and biocompatibility documentation required for the base glove category.

Q7. What happens if we sell unregistered medical gloves in India? 

Importing, distributing, or selling unregistered medical gloves is a criminal offence under the Drugs and Cosmetics Act, 1940. Given the heightened post-pandemic regulatory and market attention to glove quality and registration compliance, enforcement focus on this category has intensified. Consequences include product seizure and destruction, cancellation of IEC and business licences, financial penalties, imprisonment of up to 3 years, and reputational damage.

Q8. Can one CDSCO licence cover multiple glove sizes from the same manufacturer?

Yes, generally. Multiple sizes (XS through XL) of the same fundamental product formulation and design from a single manufacturer can typically be covered under a single application, provided size-specific dimensional and AQL data is included where required. Distinctly different product lines (e.g., examination gloves vs. surgical gloves vs. chemotherapy-rated gloves) from the same manufacturer typically require separate registration consideration given their differing classification and standards requirements.