How to Read Examination Glove Certificates and Spec Sheets

Pacific Resource Global editorial team

Quick answer: Every glove document answers one of four questions. A product certificate, such as an EU Type-Examination certificate, tells you which glove was assessed and what it was assessed against. A quality-system certificate, such as ISO 13485:2016, tells you how the factory is run. A test report, such as an SGS report, tells you how one tested lot performed. An authorised-representative letter tells you who represents the manufacturer in the EU. Before you rely on any of them, check that the product, the size, the lot and the issuing body all match the gloves you are buying.

1. Start with the four document types

Document	What it proves	What it does not prove
EU Type-Examination certificate (PPE Regulation (EU) 2016/425)	The named product reference was examined by a Notified Body against named standards.	That every other glove from the factory is covered.
ISO 13485:2016 certificate	The manufacturer runs a medical-device quality management system within a stated scope.	That a particular product carries a CE mark.
Lab test report	The results for one sample from one lot, tested to one method.	Future lots, or other sizes and materials.
EU authorised-representative appointment (MDR (EU) 2017/745)	A named company acts for a non-EU manufacturer in the EU.	Any product certification.

2. Reading an EU Type-Examination certificate

Look for these fields:

• Notified Body number and name. The four-digit number appears on the certificate, and you can look it up in the EU NANDO database.
• Certificate number. This is different from the product reference.
• Product reference and description. The certificate covers only the products listed here.
• Category. Category III PPE protects against risks with very serious consequences, which is why a Notified Body has to be involved.
• Standards applied. For chemical and microorganism protection these are typically EN ISO 21420 (general requirements), EN ISO 374-1 (chemicals, Type A/B/C) and EN ISO 374-5 (micro-organisms).
• Dates. The issue date and the expiry date.

Our example. Our own factory in Selangor has operated since 2009. It holds EU type-examination certificate 2777/26778-01/E00-00 issued by SATRA (NB 2777) for product reference BRI-47173-A: powdered latex examination gloves, non-sterile, size M as listed on the certificate. It was issued under Module B of Regulation (EU) 2016/425, Category III. It lists EN ISO 21420:2020, EN ISO 374-1:2016+A1:2018 (Type B) and EN ISO 374-5:2016 (bacteria and fungi: pass; viruses: not claimed). It is our only CE certificate. It does not cover nitrile, powder-free latex or PROTECTOR® antimicrobial gloves.

3. Reading an ISO 13485:2016 certificate

ISO 13485:2016 is a quality management system standard for medical-device organisations. When you read one, check:

• the legal entity and address, which should match the factory you are buying from;
• the scope, meaning which products and which activities are covered;
• the certification body, and whether it is accredited;
• the validity dates.

Our factory's ISO 13485:2016 certificate (registration no. 510309 MP2016, valid until 2028-01-16) is issued by DQS Certification (M) Sdn Bhd. Its scope is the manufacture and distribution of non-sterile latex powdered and powder-free examination gloves, and non-sterile nitrile powder-free examination gloves. Like any QMS certificate, it is not a product CE mark. Our factory also holds ISO 9001 certification.

4. The EU authorised representative

A manufacturer based outside the EU appoints an EU authorised representative. Ours is Obelis s.a., appointed under MDR (EU) 2017/745. An appointment letter is not a product certificate, so treat any "CE MDR certified" claim that rests on such a letter with caution.

5. Reading a spec sheet: the standards behind the numbers

• EN 455 (Parts 1–4). This is the European series for single-use medical gloves. Part 1 covers freedom from holes, Part 2 physical properties (dimensions and strength), Part 3 biological evaluation (for example powder and protein) and Part 4 shelf life.
• ASTM D3578. The US specification for rubber (natural latex) examination gloves.
• ASTM D6319. The US specification for nitrile examination gloves.
• ISO 11193-1. The international specification for single-use medical examination gloves made from rubber latex or rubber solution.

On a spec sheet you will usually see the following:

• Dimensions. Length, palm width, and thickness at the palm and the finger, in mm.
• Force at break and elongation. Measured before and after accelerated ageing, because ageing shows how the glove holds up in storage.
• Freedom from holes. A water-leak test reported against an AQL.
• Residual powder. In mg per glove.

Always check which standard and which edition each number was tested against. A figure is only meaningful next to its test method.

6. What AQL really means

AQL (Acceptable Quality Limit) comes from attribute sampling plans in the ISO 2859-1 tradition. A sample is drawn from a lot, and the lot is accepted if the number of non-conforming gloves is at or below the plan's accept number. A lower AQL is a stricter plan. AQL is a lot-acceptance rule, so it is not a promise that a set percentage of gloves are defective.

Our specification is AQL 2.5 for latex examination gloves and AQL 1.5 for nitrile examination gloves.

7. A worked example: an SGS report for latex lot 20251010

SGS tested powdered latex examination gloves from our lot 20251010 (size M) against ISO 11193-1:2020:

• Freedom from holes (SGS report CPSA/251272402-CB88485, lot 20251010): 500 gloves tested to ISO 11193-1:2020 at AQL 2.5. The accept number was 21 and 15 gloves were non-conforming (leaking), so the lot was accepted.
• Dimensions: width 99–100 mm (requirement 95 ± 10), length 236–240 mm (min. 230), palm thickness 0.08–0.09 mm and finger thickness 0.12–0.13 mm (min. 0.08). All conformed.
• Force at break: 10.4–12.3 N before ageing (min. 7.0) and 9.4–11.0 N after ageing (min. 6.0). Elongation was 700–730% before ageing and 660–700% after. All conformed.
• Residual powder: 6.45 mg per glove. ISO 11193-1 sets a 10 mg maximum for powdered gloves.

The reports are available as PDFs on our certificates page.

8. A checklist to use before you place an order

1. Does the product reference on the certificate match the glove you are buying, including its material and whether it is powdered?
2. Do the certificate number and Notified Body check out in NANDO?
3. Do the QMS scope and address match the factory?
4. Is the test report for the same product, size and recent lot?
5. Is the AQL stated for each test, and what are the accept numbers?
6. Is the market clear? Our US-line nitrile gloves are industrial / general-purpose (non-medical).

FAQ

Is ISO 13485 the same as a CE mark?
No. ISO 13485:2016 certifies a quality management system. A CE mark depends on the product's own conformity assessment.

Does an EU authorised representative mean the gloves are CE certified?
No. Our authorised representative, Obelis, is appointed under MDR (EU) 2017/745 to represent us in the EU. The appointment is not a product certification.

Which of your gloves have a CE certificate?
Only product reference BRI-47173-A, our powdered latex examination gloves. They are covered by EU type-examination certificate 2777/26778-01/E00-00 issued by SATRA (NB 2777) under PPE Regulation (EU) 2016/425, Category III.

What AQL do your gloves meet?
Latex examination gloves are made to AQL 2.5 and nitrile examination gloves to AQL 1.5.

Is a lower AQL better?
A lower AQL means a stricter sampling plan for accepting a lot. Compare it alongside the standard and the test it applies to.

About the manufacturer

Pacific Resource Global's gloves are made at our own factory in Sungai Buloh, Selangor, Malaysia, which has operated since 2009. The company was founded in 2019. Annual capacity is about 2 billion pieces. To request any document mentioned here, use the certificate request or contact us.