China has replaced its two national standards for disposable medical examination gloves. Rubber examination gloves move from GB 10213-2006 to GB/T 10213-2025, and poly(vinyl chloride) (PVC) examination gloves move from GB 24786-2009 to GB/T 24786-2025. Both new editions took effect on 1 September 2026. Regulatory, quality and sourcing teams usually ask three questions: is the new edition still mandatory, which test items apply, and which mark (CNAS or IAS accreditation, or CMA qualification) can the test report carry? This guide answers each one from the official standard records and the accreditation and qualification scopes of SUNGO's Shanghai laboratory, and ends with a checklist for preparing a submission.
Key points
- The new numbers carry "/T". China's national standards information platform lists GB/T 10213-2025 (Single-use medical rubber examination gloves) and GB/T 24786-2025 (Single-use medical poly(vinyl chloride) examination gloves) as recommended national standards. Both were published on 2025-08-29 and implemented on 2026-09-01. They fully replace the mandatory GB 10213-2006 and GB 24786-2009.
- Five items of the new editions are in SUNGO Shanghai's CNAS and CMA scopes. The CNAS (L22083) and CMA (240015340087) scopes of Shanghai SUNGO Medical Technology Co., Ltd. list five items for both 2025 editions: dimensions, watertightness test, tensile properties, packaging and marking. Clauses not listed in the scopes cannot be reported with a CNAS or CMA mark. In those scopes the numbers are written GB 10213-2025 and GB 24786-2025.
- The CMA scope also keeps the old editions. The same five items under GB 10213-2006 and GB 24786-2009 remain in the Shanghai CMA scope. The CNAS scope lists only the 2025 editions.
- The IAS scope lists whole standards without a year. The Shanghai IAS scope (TL-1019) lists GB/T 10213 and GB/T 24786 as whole standards.
- Other glove standards, including EN and ASTM, are also covered in Shanghai. The Shanghai scopes also include GB/T 24787-2009, the EN 455 series, and ASTM D3578, D6319, D5250 and D6977. None of the EN or ASTM standards is in the CMA scope, and EN 455-3 is accredited for specific clauses only.
- Biological tests are subcontracted. Cytotoxicity, sensitization, irritation and other biological tests are subcontracted by SUNGO to appropriately qualified laboratories. Under accreditation rules, the client's agreement is obtained in advance, and the report identifies the subcontracted items and the subcontractor.
The standards and their scope
The details below come from the standard records on China's national standards information platform and its national standards full-text system, checked on 2026-10-22.
GB/T 10213-2025 Single-use medical rubber examination gloves
- Status: recommended national standard, listed as current.
- Published 2025-08-29; implemented 2026-09-01. Issued by the State Administration for Market Regulation (SAMR) and the Standardization Administration of China (SAC).
- Fully replaces GB 10213-2006. The previous edition was a mandatory national standard (published 2006-03-14, implemented 2006-12-01) and is now listed as withdrawn.
- Adoption: identical to ISO 11193-1:2020, Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution.
- Responsible committee: National Technical Committee on Rubber and Rubber Products (TC35), executed by its Latex Products Subcommittee (TC35SC4); competent department: China Petroleum and Chemical Industry Federation.
GB/T 24786-2025 Single-use medical poly(vinyl chloride) examination gloves
- Status: recommended national standard, listed as current.
- Published 2025-08-29; implemented 2026-09-01, the same dates as GB/T 10213-2025.
- Fully replaces GB 24786-2009. The previous edition was a mandatory national standard (published 2009-12-15, implemented 2010-10-01) and is now listed as withdrawn.
- Adoption: modified from ISO 11193-2:2006, Single-use medical examination gloves — Part 2: Specification for gloves made from poly(vinyl chloride).
- Same responsible committee, executing subcommittee and competent department as GB/T 10213-2025.
How to read the scope
Both new editions adopt ISO standards, and the full-text system states that their text is not available online for copyright reasons. Based on the adoption titles, GB/T 10213-2025 covers examination gloves made from rubber latex or rubber solution, and GB/T 24786-2025 covers PVC examination gloves. For glove types, size codes, technical requirements and acceptance values, refer to the standard text itself. This guide does not quote any limits.
GB or GB/T?
The platform lists the new editions as GB/T 10213-2025 and GB/T 24786-2025. In SUNGO Shanghai's CNAS and CMA scopes they are written "GB 10213-2025" and "GB 24786-2025"; only the "dimensions" row of the CNAS scope reads "GB/T 10213-2025". The test-item tables below reproduce the scope wording, and the rest of the text uses the platform numbers. For contracts and product technical requirements, we suggest using the numbers as listed on the platform.
A related mandatory standard
China also published the mandatory national standard GB 24788-2025, Safety technical requirements for medical gloves. It was published on 2025-05-30, takes effect on 2028-06-01, and will then fully replace GB 24788-2009 (Limit for the removable surface powder and water-extractable protein of medical gloves). Which gloves it applies to and what it requires should be checked against the standard text. GB 24788-2025 is not among the test items listed in this guide.
Test items
The two tables below reproduce the items, clauses and limitations for the 2025 editions as listed in SUNGO Shanghai's CNAS scope, and note whether the CMA scope lists the same item. In the CNAS scope these rows are effective from 2026-03-09; in the CMA scope the 2025-edition rows are effective from 2026-02-14. The CMA scope gives no clause numbers for these items.
Single-use medical rubber examination gloves (written GB 10213-2025 in the scopes)
| Item | Clause | Notes / limitations |
|---|---|---|
| Dimensions | 7.1 | In both CNAS and CMA scopes; no limitation stated. This CNAS row reads GB/T 10213-2025 |
| Watertightness test | 7.2, Annex A | In both CNAS and CMA scopes; no limitation stated |
| Tensile properties | 7.3 | In both CNAS and CMA scopes; no limitation stated. CNAS also lists ISO 37:2024 and GB/T 3512-2014 for this item; CMA also lists GB/T 3512-2014 |
| Packaging | 8 | In both CNAS and CMA scopes; no limitation stated |
| Marking | 9 | In both CNAS and CMA scopes; no limitation stated |
Single-use medical PVC examination gloves (written GB 24786-2025 in the scopes)
| Item | Clause | Notes / limitations |
|---|---|---|
| Dimensions | 7.1 | In both CNAS and CMA scopes; no limitation stated |
| Watertightness test | 7.2, Annex A | In both CNAS and CMA scopes; no limitation stated |
| Tensile properties | 7.3 | In both CNAS and CMA scopes; no limitation stated. CNAS also lists GB/T 528-2009 and GB/T 3512-2014 for this item; CMA also lists GB/T 3512-2014 |
| Packaging | 8 | In both CNAS and CMA scopes; no limitation stated |
| Marking | 9 | In both CNAS and CMA scopes; no limitation stated |
Of the method standards listed under tensile properties, ISO 37:2024 and GB/T 528-2009 cover the determination of tensile stress-strain properties, and GB/T 3512-2014 covers hot-air accelerated ageing and heat resistance tests. Ageing conditions, specimen preparation and acceptance criteria follow the standard text.
Old editions kept in the CMA scope
If a product technical requirement or purchase contract still cites an old edition, the table below applies. These rows are effective in the CMA scope from 2024-11-25. The CNAS scope does not include the old editions.
| Item | Clause | Notes / limitations |
|---|---|---|
| Dimensions | No clause given in the scope | GB 10213-2006 and GB 24786-2009 both in the CMA scope |
| Watertightness test | No clause given in the scope | GB 10213-2006 and GB 24786-2009 both in the CMA scope |
| Tensile properties | No clause given in the scope | GB 10213-2006 and GB 24786-2009 both in the CMA scope; GB/T 3512-2014 also listed |
| Packaging | No clause given in the scope | GB 10213-2006 and GB 24786-2009 both in the CMA scope |
| Marking | No clause given in the scope | GB 10213-2006 and GB 24786-2009 both in the CMA scope |
The old editions are listed as withdrawn on the platform; which edition to test to depends on the product technical requirements and the applicable regulatory requirements.
Other glove standards covered by the same laboratory
For export markets or customer-specified standards, the accreditation and qualification scopes of the Shanghai laboratory also cover the glove standards below. Editions, clauses and limitations follow the CNAS scope; IAS entries follow the wording of the IAS scope.
| Item | Clause | Notes / limitations |
|---|---|---|
| Single-use non-sterile rubber surgical gloves: dimensions, watertightness test, tensile properties, packaging, marking (GB/T 24787-2009) | 6.1; 6.2, Annex A; 6.3; 7; 8 | In both CNAS and CMA scopes; GB/T 528-2009 and GB/T 3512-2014 also listed for tensile properties; the IAS scope lists GB 24787 |
| Medical gloves for single use: watertightness test (EN 455-1:2020+A2:2024) | No clause given in the scope | CNAS; the IAS scope lists EN 455-1 and BS EN 455-1 |
| Medical gloves for single use: physical properties (EN 455-2:2024) | No clause given in the scope | CNAS; the IAS scope lists EN 455-2 and BS EN 455-2 |
| Medical gloves for single use: powder residue (EN 455-3:2023) | 4.4 | CNAS limitation: clause 4.4 (powder residue) only; IAS limitation for EN 455-3 and BS EN 455-3: "only 5.2" (refer to the standard text for what clause 5.2 covers) |
| Medical gloves for single use: shelf life (EN 455-4:2009) | No clause given in the scope | CNAS; the IAS scope lists EN 455-4 and BS EN 455-4 |
| Rubber examination gloves: watertightness test, physical and dimensional properties, powder residue, water-soluble protein content (ASTM D3578-19(2023)) | 8.3; 8.4, 8.5; 8.6, 8.8; 8.7 | CNAS; also listed: ASTM D5151-19(2023) for watertightness, ASTM D412-16(2021) and ASTM D3767-03(2020) for physical and dimensional properties, ASTM D6124-06(2022) for powder residue; the IAS scope lists ASTM D3578 |
| Medical nitrile gloves: watertightness test, physical and dimensional properties, powder residue (ASTM D6319-19(2023)) | 7.3; 7.4, 7.5; 7.6, 7.7 | CNAS; also listed: ASTM D5151-19(2023) for watertightness, ASTM D412-16(2021) and ASTM D3767-03(2020) for physical and dimensional properties; the IAS scope lists ASTM D6319 |
| Medical PVC gloves: watertightness test, physical and dimensional properties, powder residue (ASTM D5250-19(2023)) | 7.3; 7.4, 7.5; 7.6, 7.7 | CNAS; method standards ASTM D5151, D412, D3767 and D6124 also listed (same editions as above); the IAS scope lists ASTM D5250 |
| Medical polychloroprene examination gloves: watertightness test, physical and dimensional properties, powder residue (ASTM D6977-19(2023)) | 7.3; 7.4, 7.5; 7.6, 7.7 | CNAS; method standards ASTM D5151, D412, D3767 and D6124 also listed (same editions as above); the IAS scope lists ASTM D6977 |
| Rubber surgical gloves: watertightness test, physical and dimensional properties, powder residue, water-soluble protein content (ASTM D3577-19(2023)) | 8.3; 8.4, 8.5; 8.6, 8.8; 8.7 | CNAS only; also listed: ASTM D5151-19(2023) for watertightness, ASTM D412-16(2021) and ASTM D3767-03(2020) for physical and dimensional properties, ASTM D6124-06(2022) for powder residue; ASTM D3577 is not in the IAS scope |
| Medical gloves: shelf life (YY/T 0616.2-2016) | No clause given in the scope | In both CNAS and CMA scopes |
| Medical gloves: shelf life (ASTM D7160-16(2023)) | No clause given in the scope | CNAS only |
| Medical gloves: powder residue (GB/T 21869-2008) | No clause given in the scope | In both CNAS and CMA scopes; the IAS scope lists GB/T 21869 |
The IAS scope also lists EN ISO 21171 (Medical gloves — Determination of removable surface powder), which is not in the CNAS or CMA scope.
Where the testing is done and under which accreditation
Medical glove testing is done in Shanghai. The laboratory, at No. 958 Kangqiao East Road, Pudong New Area, Shanghai, belongs to Shanghai SUNGO Medical Technology Co., Ltd., and reports are issued by that company. It holds two accreditations (CNAS and IAS) and a CMA qualification. Which mark a given item can carry depends on which scope lists that item.
- CNAS laboratory accreditation, registration no. CNAS L22083. All five items of both 2025 editions are in scope, with the clauses shown above; the EN 455 series and ASTM glove standards listed above are also in the CNAS scope. The CNAS certificate states that CNAS is a signatory to the mutual recognition arrangements of ILAC and APAC.
- CMA (China inspection and testing body qualification), certificate no. 240015340087. The scope lists the five items for both the 2025 and the old editions. The CMA mark can only be used for items in its scope, and the certificate states that it is valid within the People's Republic of China. None of the EN or ASTM glove standards in this guide is in the Shanghai CMA scope, so those items cannot be reported under CMA.
- IAS accreditation, certificate no. TL-1019. The scope lists whole standards, without years, including GB/T 10213, GB/T 24786, GB 24787, ISO 11193-1, EN 455 and several ASTM glove standards; for EN 455-3 only 5.2 is accredited. Items that are in the CNAS or CMA scope but not in the IAS scope (for example ASTM D3577) cannot be reported under IAS.
SUNGO also operates a laboratory in Hefei under a separate legal entity, Hefei SUNGO Medical Technology Co., Ltd. Its accreditation and qualification scopes do not include medical glove items, so glove testing is not performed there.
If your registration file or customer also requires biological tests (cytotoxicity, sensitization, irritation and so on), SUNGO subcontracts them to appropriately qualified laboratories. Under accreditation rules, the client's agreement is obtained in advance, and the report identifies the subcontracted items and the subcontractor. The EN 455-3 entries above cover only powder residue (CNAS clause 4.4) and clause 5.2 in the IAS scope; they do not mean SUNGO performs biological evaluation itself.
Whether an overseas customer or regulator accepts a particular type of report or mark is for that party to decide, so please confirm before ordering.
Preparing your submission
- State the standard and edition. Tell us whether testing should follow GB/T 10213-2025 or GB/T 24786-2025, an old edition cited in your product technical requirements, or an EN or ASTM standard. Clause numbers and available marks differ between editions.
- Provide product information. Material, powdered or powder-free, surface finish, sterile or non-sterile, size codes and a list of models and specifications. If several models are submitted together, describe how they differ.
- Attach technical documents. Product technical requirements (if any), instructions for use, and label and packaging marking artwork. The packaging and marking items are checked against these documents and the actual product.
- Sample condition. Submit finished gloves in their original packaging, with lot number, manufacturing date and expiry date. Label different models and lots separately. The number of samples depends on the sampling provisions of the standard and the test plan; please confirm with us before ordering.
- State your report requirements. Tell us whether you need a CNAS, CMA or IAS mark and whether the report is for domestic registration, export or customer acceptance. We will then check each item against the scopes and tell you which mark it can carry.
- Mention other tests up front. If you also need shelf-life testing (for example YY/T 0616.2-2016 or EN 455-4:2009) or biological tests, raise them at submission so they can be planned together; biological tests are subcontracted as described above.
FAQ
Is GB 10213-2025 still a mandatory standard?
No. The national standards platform lists the new edition as GB/T 10213-2025, a recommended national standard published on 2025-08-29 and implemented on 2026-09-01, fully replacing the mandatory GB 10213-2006. GB/T 24786-2025 is likewise recommended and replaces the mandatory GB 24786-2009.
Can SUNGO issue CNAS and CMA reports to GB/T 10213-2025 and GB/T 24786-2025?
Yes, but only for the five items listed in the scopes: dimensions, watertightness test, tensile properties, packaging and marking. Clauses not listed in the scopes cannot be reported with a CNAS or CMA mark. These five items are in the CNAS (L22083) and CMA (240015340087) scopes of Shanghai SUNGO Medical Technology Co., Ltd., which write the numbers as GB 10213-2025 and GB 24786-2025.
Our product technical requirements still cite GB 10213-2006. Can we test to the old edition?
The Shanghai CMA scope still includes the five items of GB 10213-2006 and GB 24786-2009, while the CNAS scope lists only the 2025 editions. Which edition to use depends on your product technical requirements and the applicable regulatory requirements, so please state the edition when ordering.
How do the new editions relate to ISO 11193?
According to the platform's adoption records, GB/T 10213-2025 is identical to ISO 11193-1:2020, and GB/T 24786-2025 is modified from ISO 11193-2:2006. The Shanghai IAS scope lists ISO 11193-1 as a whole standard, with no year given.
Can SUNGO do cytotoxicity, sensitization and irritation tests on gloves?
These biological tests are subcontracted by SUNGO to appropriately qualified laboratories. Under accreditation rules, the client's agreement is obtained in advance, and the report identifies the subcontracted items and the subcontractor.
Request a quote
To test to GB/T 10213-2025 or GB/T 24786-2025, or to check which scope an item is in and which mark it can carry, start with our medical mask and medical glove testing service. For shelf-life items see shelf-life validation. To request a quote, send your product type, model list, required standards and report requirements through our contact page, and we will reply item by item against the CNAS, IAS and CMA scopes.