Three frameworks decide whether a glove shipment clears your market: ISO 13485 for the factory's quality system, FDA registration for the US, and CE marking under the MDR or PPE Regulation for Europe, with EN product standards (EN 455, EN 374, EN 1186) proving the glove itself. The fastest way to qualify a supplier is to request the certificate, the registration numbers, and the test reports before you negotiate price. This article maps what each layer covers and what paperwork to ask for.

Why Do Certification Checks Come Before Price Talks?

A container of gloves that cannot be legally sold in your market is worth zero, regardless of the unit price. Compliance is also the cheapest filter you have: a factory that cannot produce a valid ISO 13485 certificate or a coherent Declaration of Conformity in one email round will not suddenly become reliable after you wire a deposit. Spend one afternoon on paperwork and you eliminate most of the risk before samples even ship.

What Does ISO 13485 Tell You About the Factory?

ISO 13485 is the quality management system standard for medical device manufacturers. It does not certify a product; it certifies that the factory runs documented processes for design control, production, traceability, and corrective action. When you evaluate a glove factory, ask for the certificate and read three things: the issuing body, the expiry date, and the scope. The scope should explicitly cover manufacture of disposable medical gloves, not just "distribution" or an unrelated product line.

Our plant in Taishan, Guangdong operates under an ISO 13485 certified quality system, covering the full flow from compounding and dipping lines through chlorination, packaging, and the purification workshop. You can read more about the facility on our about page.

What Does the US Market Require: FDA Registration or FDA Approval?

For the US, the correct vocabulary matters. Disposable nitrile examination gloves are Class I medical devices. The baseline requirement is establishment registration and device listing: the foreign manufacturer registers its establishment with the FDA and lists the device, and our nitrile glove products carry FDA registration information for this purpose. Registration is not approval. Depending on the specific product code and intended use, a 510(k) premarket notification may also apply, so confirm the exact regulatory pathway for your SKU with your US agent or regulatory consultant before ordering.

When a supplier says "FDA approved" for an exam glove, treat it as a red flag in wording at minimum. What you want to receive is the registration and listing numbers, which you can look up yourself in the FDA's public registration and listing database. If the numbers do not match the legal manufacturer name, ask why.

What Does CE Marking Mean for Gloves Sold in Europe?

In Europe the same glove can fall under two different legal frameworks, and serious suppliers separate them clearly:

• Medical Device Regulation (EU) 2017/745 (MDR). Examination gloves for medical use are Class I medical devices. The manufacturer self-declares conformity, issues a Declaration of Conformity (DoC), and affixes the CE mark. Our nitrile glove products carry CE registration information under this framework.
• PPE Regulation (EU) 2016/425. Gloves sold as protective equipment against chemicals or biological agents are Category III PPE, which requires type examination by a notified body and ongoing conformity assessment. This is a different CE claim from the MDR one, with a notified body number attached.

The practical takeaway: ask which regulation the CE mark on the box refers to, and request the DoC for each claim. A DoC should name the regulation, the product model, the applied standards, and the manufacturer's legal entity.

Which EN Product Standards Should Appear on a Datasheet?

Registrations open the door; product standards describe the glove itself. Three families cover nearly every use case a distributor buys for:

Standard	Scope	Typical claim on a datasheet	Document to request
EN 455 (parts 1-4)	Single-use medical gloves	Freedom from holes AQL 1.5, force at break 6-7 N, shelf life 5 years	Test report per part
EN 374 / ISO 374	Protection against chemicals and micro-organisms	Chemical splash and virus penetration resistance	Test report with chemicals tested
EN 1186	Food contact materials	Migration limits for food handling use	Migration test report

As a concrete reference, our KG-1101 3.5g nitrile examination gloves datasheet lists EN 455, EN 374, and EN 1186 together, with AQL 1.5, force at break 6 N, elongation 400%, length 240 mm, and a 5-year shelf life. The heavier KG-1303 6.0g nitrile glove adds a chemo-grade claim for heavier-duty medical use. If a supplier's datasheet quotes standards without numbers behind them, ask for the underlying reports.

Which Documents Should You Request Before Ordering?

A complete pre-order document pack from a glove factory is not long. Ask for:

• ISO 13485 certificate, with scope and expiry date
• FDA establishment registration and device listing numbers (for US-bound goods)
• Declaration of Conformity per market claim (MDR, PPE, or food contact)
• Third-party test reports for the specific model you are buying: EN 455 parts 1-4 for medical use, EN 374 for chemical claims, EN 1186 for food contact
• Product datasheet with physical values (thickness, force at break, elongation, AQL) that match the test reports

Note the phrase "the specific model you are buying." A test report for a 4.0g glove does not validate a 3.0g glove, even from the same line. Match the item code on the report to the item code on your purchase order.

How Do You Sanity-Check the Paperwork?

Most checks take minutes. Verify the ISO 13485 certificate number against the issuing certification body's online directory. Search the FDA registration and listing database for the manufacturer name and compare it to the entity on your proforma invoice. Read the DoC for internal consistency: same legal entity, same product model, standards that actually correspond to the claim. Finally, compare test report dates against the shelf life logic; a report from eight years ago for a glove with a 5-year shelf life deserves a follow-up question. None of this requires a consultant, and it catches the majority of recycled or borrowed paperwork.

FAQ

Is FDA registration the same as FDA approval?

No. Establishment registration and device listing mean the manufacturer and device are recorded with the FDA; it is not an evaluation or endorsement of the product. Approval or 510(k) clearance is a separate, higher bar that applies to specific device categories. When sourcing exam gloves, ask for registration and listing numbers you can verify, and confirm with a regulatory consultant whether your product code needs anything further.

What is EN 455?

EN 455 is the four-part European standard for single-use medical gloves. Part 1 covers freedom from holes (typically AQL 1.5), part 2 covers physical properties such as force at break and elongation, part 3 covers biological evaluation, and part 4 covers shelf-life determination. A medical-grade nitrile glove sold in Europe should have test evidence for all four parts.

Does a CE mark mean a glove is medical grade?

Not by itself. Gloves can carry CE marking under the Medical Device Regulation (MDR), under the PPE Regulation for chemical or biological protection, or as food-contact articles. Ask for the Declaration of Conformity and check which regulation and standards it cites before assuming medical-grade status.

Which documents should I request before placing a glove order?

At minimum: the ISO 13485 certificate, FDA registration and listing numbers for US-bound goods, a Declaration of Conformity for each market claim, model-specific test reports (EN 455, EN 374, EN 1186 as applicable), and a datasheet whose physical values match those reports. Verify certificate and registration numbers against the public databases of the issuing bodies.

Need a document pack for your market? Contact our export team and we will send the ISO 13485 certificate, registration information, and test reports for the model you are evaluating. You can also review the specs directly on the KG-1101 nitrile glove series or our MXGUARD nitrile exam gloves pages.

AQL, or Acceptable Quality Limit, is the statistical measure used to judge pinhole defects in disposable gloves. For medical examination gloves, most professional buyers specify AQL 1.5: it is the level required by EN 455-1 for the European market and it exceeds the FDA minimum for patient examination gloves in the US. Our KG-1101 nitrile examination gloves are produced at AQL 1.5 across the whole line.

What Does AQL Actually Mean?

AQL stands for Acceptable Quality Limit (often written Acceptable Quality Level). It comes from the sampling standards ISO 2859-1 and ANSI/ASQ Z1.4, which define how many pieces are drawn from a production lot and how many defective pieces are allowed before that lot is rejected.

Two points matter for buyers:

• AQL is a process average, not a per-box guarantee. An AQL 1.5 sampling plan accepts production running at roughly 1.5 defects per 100 gloves as its long-term average. An individual box can still contain a defective glove; what the plan controls is that the overall lot stays within the limit.
• AQL applies to a defined defect class. For examination gloves, the defect that counts is a pinhole that breaks the barrier. Cosmetic marks or minor stains are different defect classes with their own, looser AQL values.

The smaller the AQL number, the tighter the requirement: AQL 1.5 is stricter than 2.5, which is stricter than 4.0.

How Are Pinholes Tested?

The standard method is the water leak test. EN 455-1, the European standard for freedom from holes in medical gloves, and ASTM D5151, its US counterpart, use essentially the same procedure: the glove is filled with 1,000 mL of water, hung by the cuff for two minutes, and examined for any droplet or wet streak on the outside. One visible leak means the glove fails.

Because the test destroys the glove, it is always done on a sample. Under ISO 2859-1 single sampling at General Inspection Level I, a production lot of 35,001 to 150,000 gloves is judged on a random sample of 200 gloves. The acceptance numbers then depend directly on the AQL:

• At AQL 1.5, the lot passes if 7 or fewer gloves leak, and is rejected at 8 or more.
• At AQL 2.5, the same sample passes with up to 10 leakers.
• At AQL 4.0, it passes with up to 14.

This is the practical meaning of the numbers. Moving from AQL 2.5 to AQL 1.5 is not marketing language; it changes the pass/fail line on the inspection table, and it forces the factory to hold its true pinhole rate well below 1.5 percent, otherwise lots start failing.

AQL 1.5 vs 2.5 vs 4.0: Where Each Level Is Used

AQL level	Indicative defect average	Typical acceptance use
AQL 4.0	Up to ~4 leakers per 100 gloves	Industrial, food-service and general-purpose gloves; not accepted as medical gloves in most markets
AQL 2.5	Up to ~2.5 leakers per 100 gloves	US minimum for patient examination gloves (FDA 21 CFR 800.20); ASTM D6319 nitrile exam gloves
AQL 1.5	Up to ~1.5 leakers per 100 gloves	EN 455-1 medical gloves for Europe; FDA level for surgeons’ gloves; standard requirement in most medical tenders
AQL 1.0	Up to ~1 leaker per 100 gloves	Premium or specialty orders; tighter sampling raises inspection cost, so agree the plan with the factory in advance

Why Do Medical Buyers Usually Ask for AQL 1.5?

The main reason is regulatory coverage. EN 455-1 sets AQL 1.5 as the freedom-from-holes requirement for medical gloves sold in Europe, and the FDA applies the same 1.5 level to surgeons' gloves. A glove line produced at AQL 1.5 can therefore be documented for both markets with one specification, while an AQL 2.5 line only covers the US examination-glove minimum.

The second reason is barrier margin. Cutting the acceptable defect average from 2.5 to 1.5 removes roughly 40 percent of the tolerated pinholes. For distributors supplying hospitals, dental chains or laboratories, that difference shows up directly in complaint and return rates.

The third reason is tender eligibility. Hospital and government tenders commonly write "AQL 1.5 per EN 455-1" into their technical schedules, so importers who buy at that level can bid without re-testing or re-specifying product.

Our own production follows this level. The KG-1101 3.5g, 4.0g and 5.0g nitrile examination gloves, and the heavy-duty KG-1303 6.0g chemo-grade glove, are all produced at AQL 1.5, with every lot tested for freedom from holes before shipment.

What Should You Put in a Purchase Specification?

A purchase spec that only says "medical grade" or "low pinhole rate" is not enforceable. Write the numbers in:

1. Defect class and AQL value: "Freedom from holes (pinholes): AQL 1.5".
2. Test method: EN 455-1 water leak test or ASTM D5151.
3. Sampling plan: ISO 2859-1 or ANSI/ASQ Z1.4, General Inspection Level I, single sampling, normal inspection.
4. Product standard: EN 455-1 for the European market, ASTM D6319 for US nitrile examination gloves.
5. Lot documentation: a certificate of analysis for each production lot, including the water leak test result.
6. Inspection arrangement: who inspects (the factory or a third party such as SGS, TÜV or Intertek), at what stage (pre-shipment is normal), and what happens if a lot fails (sorting, replacement or rejection, and who pays for it).

With those six lines in the purchase order, both sides know exactly how a lot will be judged, and an arriving container can be checked against the same plan.

FAQ

Is AQL 1.5 good for examination gloves?

Yes. AQL 1.5 is the level EN 455-1 requires for medical gloves in Europe and the level the FDA applies to surgeons’ gloves. It is tighter than the AQL 2.5 minimum for US patient examination gloves, and it is the level most hospitals and tenders ask for.

What AQL should I specify for medical gloves?

Specify AQL 1.5 for pinholes, tested per EN 455-1 or ASTM D5151. If you only sell into the US examination-glove market, AQL 2.5 is the regulatory floor, but most importers standardize on 1.5 so the same stock also covers Europe and tender business.

Is AQL the same as the pinhole rate?

No. AQL is a statistical acceptance limit for a production process, judged by sampling each lot. The actual pinhole rate of a well-run line is normally well below the AQL; if the process average sits at the AQL for long, lots start failing inspection.

How can I verify AQL when the goods arrive?

Ask a third-party inspector to sample the shipment per ISO 2859-1 General Inspection Level I and run the water leak test, then compare the number of leakers with the acceptance number in your purchase order. For a quick self-check, fill gloves with 1,000 mL of water, hang them for two minutes and count leaks. Also match the factory’s certificate of analysis lot by lot.

Need nitrile examination gloves produced and documented at AQL 1.5? Contact our export team for datasheets, samples and a quotation, or browse our full nitrile glove range.