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A Certificate of Conformity (CoC) is a document issued by a manufacturer or notified body confirming that a product meets specified regulatory and technical requirements. For disposable gloves, the CoC is the fastest way to verify that a batch meets the claims made on the box. 1. What a CoC Is - and What It Is Not A CoC is an attestation of compliance. It is not a test report, not an invoice, and not a marketing brochure. It should reference the exact standard, batch or lot number, and the issuing authority. If the CoC does not match the product label, the document is unreliable. 2. Eight Fields to Check on Every Glove CoC Field What to Look For Why It Matters Product description Exact glove type, material, powder-free status, size range Ensures the CoC covers the SKU you are buying Applicable standards EN 455, EN 374, ASTM D6319, ASTM D3578, ISO 11193 Confirms regulatory scope for your market Notified body / lab Name, address, accreditation (ISO 17025) Unaccredited labs produce unenforceable certificates Test report numbers Unique report IDs with dates Lets you cross-check with the lab Batch / lot number Must match the shipment label Traceability and recall management AQL level AQL 1.5, 0.65, 2.5, 4.0 Determines defect allowance and medical-grade status Expiry / validity CoC issue date and validity period Old CoCs may not reflect current formulation Authorized signature Signed by quality manager or regulatory representative Demonstrates accountability 3. Red Flags That Should Stop the Order The CoC has no test report number or the lab is not ISO 17025 accredited. The standard referenced is outdated, vague, or incorrect for the product. The batch number on the CoC does not match the physical carton label. The document is a generic template with no product-specific details. The manufacturer refuses to share the original test report or factory quality manual. 4. How to Verify the CoC Contact the test lab directly using contact details from its official website, not from the CoC itself. Provide the report number and ask for confirmation. For EU CE-marked medical gloves, check the notified body identification number in the NANDO database. For GSO-marked products, verify the registration in the GCC Standardization Organization systems or national authority portals. 5. FAQ Q: Is a CoC the same as a test report? A: No. A CoC is a declaration that the product complies with standards. A test report contains the actual measurement data from a lab. Q: Who can issue a CoC for disposable gloves? A: A manufacturer can issue a self-declaration for some standards, but medical-grade and PPE claims usually require a notified body or ISO 17025 lab. Q: How long is a CoC valid? A: There is no universal expiry, but most buyers accept CoCs issued within 1-2 years. A new formulation, standard update, or material change requires a new CoC. Q: What does AQL 1.5 on a CoC mean? A: AQL 1.5 means the accepted quality level allows up to 1.5% defective gloves in the sampled lot. Lower AQL values mean stricter quality. Q: Can I use a CoC from one country in another market? A: Not automatically. A CoC must reference the standards recognized in the target market. For example, EN 455 is for the EU; ASTM D6319 is for the US market.

ASTM and EN are the two most important standards families for disposable nitrile gloves. This cheat sheet compares key standards, test methods, AQL requirements, and physical property specs side by side, so buyers can understand what dual certification requires. ASTM International and the European Committee for Standardization (CEN) are the two primary standards bodies governing disposable medical gloves. ASTM D6319 is the US standard for nitrile examination gloves; EN 455 is the European standard for medical gloves for single use. Manufacturers selling to both the US and EU must understand the differences and achieve dual certification. This cheat sheet compares the two standards side by side. 1. Key ASTM Standards for Disposable Gloves ASTM standard Title Material ASTM D6319 Nitrile Examination Gloves for Medical Application Nitrile rubber ASTM D3578 Rubber Examination Gloves Natural rubber latex ASTM D5250 Polyvinyl Chloride Examination Gloves PVC ASTM D3577 Rubber Surgical Gloves Natural rubber latex / nitrile ASTM D6978 Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs Any 2. Key EN Standards for Disposable Gloves EN standard Title Scope EN 455-1 Medical gloves for single use - Part 1: Freedom from holes AQL and water leak test EN 455-2 Part 2: Physical properties Force at break requirements EN 455-3 Part 3: Biological evaluation Cytotoxicity, sensitization, irritation EN 455-4 Part 4: Shelf life determination Accelerated and real-time aging EN ISO 21420 Protective gloves - General requirements (formerly EN 420) pH, innocuousness, sizing, dexterity EN 374-1 to -5 Protective gloves against chemicals and micro-organisms Permeation, penetration, degradation 3. Side-by-Side: ASTM D6319 vs EN 455 for Nitrile Gloves Parameter ASTM D6319 (US) EN 455 series (EU) Governing body ASTM International CEN (European Committee for Standardization) Regulatory pathway FDA 510(k) clearance EU MDR (2017/745) via Notified Body Hole freedom test Water leak test, AQL 1.5 EN 455-1: Water leak test, AQL 1.5 Tensile strength (before aging) >= 14 MPa Not specified as MPa; EN 455-2 uses force at break Tensile strength (after aging) >= 14 MPa Not specified as MPa; force at break applies Elongation before aging >= 500% Not specified in EN 455-2 Elongation after aging >= 400% Not specified in EN 455-2 Force at break (exam gloves) Not specified in force (uses tensile strength) EN 455-2: >= 6.0 N (rubber); >= 3.6 N (thermoplastic) Force at break (surgical) Not specified (ASTM D3577 covers surgical) EN 455-2: >= 9.0 N Biological evaluation ISO 10993 series (cytotoxicity, sensitization, irritation) EN 455-3: ISO 10993 series (same test framework) Shelf life Manufacturer-defined with supporting data EN 455-4: accelerated aging + real-time stability testing required Sampling for AQL ANSI/ASQ Z1.4 (equivalent to ISO 2859-1) ISO 2859-1 4. Key Differences in Testing Approach The most important difference between ASTM and EN is how they measure physical properties. ASTM D6319 specifies tensile strength in megapascals (MPa) and elongation percentage. EN 455-2 specifies force at break in newtons (N) but does NOT specify tensile strength in MPa or elongation. This means a glove could pass one standard but not the other depending on its material formulation: ASTM approach: tensile strength and elongation on dumbbell-shaped specimens cut from the glove EN approach: force at break on a strip cut from the glove, measured in newtons Result: a nitrile glove with tensile strength of 16 MPa may have a force at break that varies with specimen width and thickness For biological evaluation, both ASTM and EN reference the ISO 10993 series, so the testing framework is aligned. The difference is in regulatory documentation: the US requires FDA 510(k) submission, while the EU requires CE marking via a Notified Body under the EU MDR. 5. AQL and Sampling Comparison Aspect ASTM / FDA (US) EN 455-1 (EU) Acceptable Quality Level AQL 1.5 for major defects (pinholes) AQL 1.5 for pinholes Premium grades Some manufacturers offer AQL 0.65 Some manufacturers offer AQL 0.65 Sampling standard ANSI/ASQ Z1.4 ISO 2859-1 Test method Water leak test (1000 mL water, 2-5 sec) Water leak test (1000 mL water, 2-5 sec) Batch release Per 21 CFR 800 + ASTM standards Per EN 455-1 + ISO 2859-1 6. Documentation Requirements for Dual Certification Requirement US (FDA 510(k)) EU (EU MDR / CE marking) Quality system 21 CFR 820 (QSR) or ISO 13485 ISO 13485 mandatory Technical file 510(k) premarket notification Technical documentation per EU MDR Annex II/III Biocompatibility ISO 10993 test reports EN 455-3 / ISO 10993 test reports Performance testing ASTM D6319 test report EN 455-1 to -4 test reports Risk management ISO 14971 (recommended) ISO 14971 (mandatory per EU MDR) Labeling English, per 21 CFR 801 Language of member state + CE mark UDI Required per FDA UDI rule Required per EU MDR UDI Post-market FDA MedWatch reporting EUDAMED registration and vigilance 7. Dual Certification Roadmap Design for both: specify nitrile rubber formulation that meets both ASTM D6319 (tensile >= 14 MPa, elongation >= 500%/400%) and EN 455-2 (force at break >= 6.0 N) Implement ISO 13485: this satisfies both FDA QSR expectations and EU MDR requirements Conduct ISO 10993 testing: biocompatibility data is accepted by both FDA and EU Notified Bodies Perform AQL testing: use ISO 2859-1 sampling (accepted by both ASTM and EN) Compile US technical file: 510(k) with ASTM D6319 performance data Compile EU technical file: EU MDR Annex II/III with EN 455-1 to -4 data Assign regulatory representatives: US Agent for FDA, Authorized Representative for EU Submit and maintain: register with FDA and obtain CE marking; update both files for any design or material changes Data sources: ASTM D6319-19; ASTM D3577; ASTM D3578; ASTM D5250; ASTM D6978; EN 455-1 to EN 455-4; EN ISO 21420:2020 (formerly EN 420); EN 374-1 to -5; EU MDR 2017/745; FDA 21 CFR 820; FDA 21 CFR 801; ISO 13485; ISO 14971; ISO 10993 series; ISO 2859-1; ANSI/ASQ Z1.4. Information current as of September 2026. FAQ Q: What is the main difference between ASTM and EN glove standards? A: The main difference is in how they measure physical properties. ASTM D6319 specifies tensile strength in megapascals (MPa) and elongation as a percentage. EN 455-2 specifies force at break in newtons (N) but does not set tensile strength or elongation requirements. Both use the same water leak test for AQL 1.5 and reference ISO 10993 for biocompatibility, but the regulatory pathways differ: FDA 510(k) for the US and CE marking via a Notified Body for the EU. Q: Can one glove meet both ASTM and EN requirements? A: Yes, many nitrile rubber gloves are dual-certified. A glove with tensile strength >= 14 MPa and elongation >= 500%/400% will typically also meet the EN 455-2 force at break requirement of >= 6.0 N for rubber examination gloves, because the two tests measure related properties through different methods. Manufacturers must conduct testing under both standards and maintain separate technical files for FDA 510(k) and EU MDR CE marking. Q: Which ASTM standard applies to nitrile examination gloves? A: ASTM D6319 is the US standard for nitrile examination gloves for medical application. It specifies tensile strength (>= 14 MPa before and after aging), elongation (>= 500% before aging, >= 400% after aging), dimensions, and AQL 1.5 for pinholes. For nitrile surgical gloves, ASTM D3577 applies. For chemotherapy drug permeation testing, ASTM D6978 applies. Q: What does EN 455-2 test that ASTM D6319 does not? A: EN 455-2 specifies force at break (measured in newtons) for different glove types: >= 6.0 N for rubber examination gloves, >= 3.6 N for thermoplastic (PVC/PE) examination gloves, and >= 9.0 N for surgical gloves. ASTM D6319 does not specify force at break in newtons; instead it uses tensile strength in MPa and elongation percentage. Conversely, ASTM D6319 specifies elongation, which EN 455-2 does not. Q: Do I need both certifications to sell in the US and EU? A: Yes, to sell medical gloves in both markets, you need both FDA 510(k) clearance (with ASTM D6319 compliance) for the US and CE marking (with EN 455 compliance) under the EU MDR for Europe. The two regulatory systems are independent. However, much of the underlying test data (ISO 10993 biocompatibility, AQL water leak testing, ISO 13485 quality system) can be shared between the two submissions.