The pinhole test, also called the water leak or watertightness test, is a lot-release check that medical glove specifications commonly require. US reports usually cite ASTM D5151, EU reports cite EN 455-1, and Chinese reports cite Annex A of GB/T 10213-2025 or GB/T 24787-2009. All detect holes by water leakage, but their operating conditions, ignored zones and lot decision rules differ, so one report cannot simply replace another. This article compares ASTM D5151 with EN 455-1, the FDA method in 21 CFR 800.20 and GB/T 10213-2025 Annex A, then answers four lab questions: cuff leaks, wet gloves, long cuffs and conditioning.
Key points
- D5151 is a test method, not a product specification. Its published scope covers detecting holes that leak water, not accepting a lot. Sample size and AQL normally come from the product specification that cites it (for example ASTM D3578 or D6319), the contract or the regulator.
- EN 455-1 and 21 CFR 800.20 are the methods whose operating details can be checked in public text. Both use about 1000 mL of water, inspect immediately and again about two minutes later (2 to 3 min in EN 455-1), and ignore leaks within 40 mm of the cuff edge; water temperature, long-glove handling, inspection level and AQL differ. D5151's own parameters should be taken from its text.
- The AQL differs most. EN 455-1 referee testing: AQL 0.65 for surgical and 1.5 for examination gloves, general inspection level I. ISO 11193-1:2020, adopted identically by GB/T 10213-2025: G-I and AQL 2.5 for watertightness. 21 CFR 800.20: general inspection level II, with 1.5 for surgeons' and 2.5 for examination gloves as minimum acceptable quality levels.
- The watertightness tests of ASTM D5151, EN 455-1 and the Chinese standards discussed here are within SUNGO Shanghai's scopes, under different marks. CNAS (L22083) lists ASTM D5151-19(2023) only for nitrile, rubber examination, rubber surgical, PVC and polychloroprene gloves; IAS (TL-1019) lists ASTM D5151 as a whole standard. EN 455-1 has CNAS and IAS; the GB 10213-2025, GB 24786-2025 and GB/T 24787-2009 tests have CNAS and CMA. ISO 11193-1 is in the IAS scope only, as a whole standard without a year. No ASTM or EN standard is in the CMA scope. 21 CFR 800.20 is in none of SUNGO's scopes and is discussed for comparison only.
The standards and their scope
ASTM D5151-19(2023)
- Title: Standard Test Method for Detection of Holes in Medical Gloves, under ASTM Subcommittee D11.40. D5151-19(2023) is the 2019 edition reapproved in 2023.
- Scope and purpose: detection of holes in medical gloves that allow water leakage under the test conditions and so compromise the glove's usefulness, as a reference method for evaluating glove samples. The smallest hole that will leak has not been determined and is out of scope, as is the safe and proper use of gloves.
- FDA recognition: listed in the FDA Recognized Consensus Standards database under recognition number 6-424, complete standard. Example product codes are KGO (surgeon's gloves), LYZ (vinyl patient examination gloves) and LZA (polymer patient examination gloves). These are FDA examples only; SUNGO's CNAS scope for D5151 covers only the five glove types in the table below.
- Citations: CDC PPE-Info lists D5151-19(2023) as referenced by ASTM D3578-19(2023) and D6319-19(2023).
The D5151 text is sold by ASTM; its public abstract shows only the scope and significance sections. Its water volume, apparatus, temperature and timing are not restated here from second-hand sources; the laboratory works to the full text.
EN 455-1:2020+A2:2024
- Title: Medical gloves for single use – Part 1: Requirements and testing for freedom of holes, as on the +A2:2024 cover; the 2020 and +A1:2022 covers and SUNGO's IAS certificate read "freedom from holes". Prepared by CEN/TC 205, published September 2024, superseding EN 455-1:2020+A1:2022. The UK edition is BS EN 455-1:2020+A2:2024.
- Structure: Clause 4, requirement (no leak when tested to Clause 5); Clause 5, watertightness test (5.1 referee testing; 5.2 routine testing by the 5.1 test or another test validated against it); Clause 6, sampling, inspection level and AQL; Clause 7, test report.
The EN 455-1 parameters below come from the public preview of +A1:2022, where Clauses 4 to 7 are visible. The +A2:2024 preview stops at the foreword, and formal reports follow the +A2:2024 text.
GB/T 10213-2025 Annex A (identical to ISO 11193-1:2020)
- GB/T 10213-2025, Single-use medical rubber examination gloves, is a recommended national standard, published 2025-08-29 and implemented 2026-09-01. It replaces GB 10213-2006 and identically adopts ISO 11193-1:2020.
- The ISO 11193-1:2020 preview shows referee sampling to ISO 2859-1 (clause 6.1), G-I and AQL 2.5 for watertightness (Table 1), and an assumed lot of 35 001 to 150 000 when lot size cannot be determined. Clause 7.2 requires testing to normative Annex A, with sample size and allowable leaking gloves taken from Table 1.
- Annex A is not visible in the preview; take clauses and values from the Chinese text.
GB/T 24787-2009 and GB/T 24786-2025
- GB/T 24787-2009, Single-use non-sterile rubber surgical gloves, was published 2009-12-15 and implemented 2010-10-01, and became a recommended standard from 2017-03-23 under Announcement No. 7 of 2017. Its watertightness test in SUNGO's scopes is clause 6.2 and Annex A; see the standard for method details.
- GB/T 24786-2025 for PVC examination gloves shares the dates of GB/T 10213-2025 and is a modified adoption of ISO 11193-2:2006. Its watertightness test is also clause 7.2 and Annex A.
21 CFR 800.20: the FDA's own method
21 CFR 800.20 sets out the visual examination and water leak method the FDA uses when sampling examination and surgeons' gloves, with sampling plans and the conditions for treating a lot as adulterated. The FDA Medical Glove Guidance Manual (22 January 2008; a front note says it has not been updated for the 2016 powdered glove ban and FDA is assessing a revision) recommends the FDA 1000 mL Water Leak Test (21 CFR 800.20) or ASTM D5151 to assess barrier integrity in stability studies, and states that the FDA uses the 21 CFR 800.20 method for regulatory testing of gloves of all materials. 21 CFR 800.20 is outside SUNGO's accreditation scopes and is cited below for comparison only.
The two public methods compared
Only parameters confirmed in public text are listed; D5151 and GB/T 10213-2025 Annex A values are not publicly visible.
| Point | EN 455-1 (5.1 referee testing) | 21 CFR 800.20 |
|---|---|---|
| Water volume | (1000 ± 50) mL | 1000 mL |
| Water temperature | 15 °C to 35 °C | Room temperature, 20 °C to 30 °C |
| Mounting | Vertical filling tube; cuff overlaps the tube end by no more than 40 mm, sealed watertight without damaging the glove | Clear cylinder 60 mm by 380 mm with a hook and a mark 40 mm from the other end (other sizes allowed); cuff brought to the mark and fastened with elastic strapping |
| Observation | Immediately after filling, repeated after 2 min to 3 min | Immediately; if no leak, hang vertically and observe again 2 minutes after filling; do not squeeze, spread fingers with minimum manipulation |
| Zone ignored | Leaks within 40 mm of the cuff | Visual defects and leaks in the top 40 mm of the glove |
| What counts | Leaks; a "hole" is a defect that allows leakage of water | Leaks and visual defects likely to affect barrier integrity, such as tears and embedded foreign objects; several defects in one glove count once, and both gloves of a pair are counted |
| Glove will not fill | A means of testing all parts must be devised, for example clamping and testing sections in turn | Notes that in large long-cuffed surgeons' gloves water may reach only the base of the thumb |
Judging a leak
21 CFR 800.20 defines a leak as water appearing on the outside of the glove, a watertight barrier failure; drops may be blotted to confirm. EN 455-1 requires no leak when tested to Clause 5. Both are visual and do not measure hole size. The D5151 scope is limited to holes that leak under test conditions and states that the smallest leaking hole has not been determined; how D5151 judges a leak should be taken from its text.
The sampling plan turns glove results into a lot decision: accept up to the acceptance number, reject at the rejection number. In 21 CFR 800.20, a lot of 501 to 1,200 is sampled once with 80 gloves; examination gloves are accepted with up to 5 defectives and rejected at 6, surgeons' gloves at 3 and 4.
Sampling plans and AQL
| Source | Inspection level | Watertightness AQL | Notes |
|---|---|---|---|
| EN 455-1 Clause 6 | General level I, but with a sample size no smaller than the minimum for code letter L (and the corresponding Ac/Re) | 0.65 surgical; 1.5 examination (referee testing) | Single or multiple plans; ISO 2859-1 and ANSI/ASQ Z1.4 cited as examples |
| ISO 11193-1:2020 Table 1 (GB/T 10213-2025) | G-I | 2.5 | To ISO 2859-1; check values in the Chinese text |
| 21 CFR 800.20(c) | General level II | 1.5 surgeons'; 2.5 examination | FDA sampling; single sampling up to 1,200, multiple sampling above |
| ASTM D3577, D3578, D6319, D5250, D6977 | See specification | See specification | Watertightness clauses are in the scope table below |
| GB/T 24787-2009, GB/T 24786-2025 | See standard | See standard | Annex A method in SUNGO's scopes |
A useful report names the document, inspection level and AQL, not just "pass".
Questions that come up in the lab
Does a leak near the cuff count?
EN 455-1 and 21 CFR 800.20 exclude only the first 40 mm from the cuff edge, the part mounted on the tube. Leaks beyond that, including the wrist area, count. For D5151 and GB/T 10213-2025 Annex A, follow the standard text.
The glove is wet outside. Can it be retested?
21 CFR 800.20 requires the outside to stay dry, so water must not be splashed onto the glove. Neither EN 455-1 nor 21 CFR 800.20 provides for replacing or retesting a leaking glove, so it counts as defective. A seal leak from poor clamping usually falls in the uncounted 40 mm zone; if it disturbs observation, record the reason and follow laboratory procedures.
A long-cuff glove will not fill. What then?
Under EN 455-1 clause 5.1, if a stretched glove is not filled by 1000 mL, a means of testing all parts must be devised and implemented without affecting hole detection; a note suggests clamping so each section is tested in turn for the required time. 21 CFR 800.20 only notes that water may reach just the base of the thumb in large long-cuffed surgeons' gloves. For long gloves going to the EU, state the cuff length and agree the sectioning method.
Do gloves need conditioning first?
Neither EN 455-1 clause 5.1 nor the method text of 21 CFR 800.20 has a separate conditioning step; only the water temperature is specified. For D5151 and the Annex A methods of GB/T 10213-2025 and GB/T 24787-2009, check the standard text. Watertightness after ageing belongs to a shelf-life study; the FDA glove guidance recommends the 21 CFR 800.20 test or D5151 for barrier integrity in stability studies. See shelf-life validation.
Accreditation scope table
Watertightness rows of SUNGO Shanghai's CNAS scope (effective 2026-03-09, no limitation on any row), with IAS coverage (whole standards, no year). Only the three Chinese rows are also in the CMA scope. No clause is listed for ASTM D5151 or EN 455-1; Chinese numbers are as written in the scope.
| Item | Standard and clause | Notes / limitations |
|---|---|---|
| Nitrile medical gloves: watertightness test | ASTM D6319-19(2023) 7.3; ASTM D5151-19(2023) | CNAS. IAS: ASTM D6319, ASTM D5151. |
| Rubber examination gloves: watertightness test | ASTM D3578-19(2023) 8.3; ASTM D5151-19(2023) | CNAS. IAS: ASTM D3578, ASTM D5151. |
| Rubber surgical gloves: watertightness test | ASTM D3577-19(2023) 8.3; ASTM D5151-19(2023) | CNAS. IAS: ASTM D5151, but not ASTM D3577. |
| PVC medical gloves: watertightness test | ASTM D5250-19(2023) 7.3; ASTM D5151-19(2023) | CNAS. IAS: ASTM D5250, ASTM D5151. |
| Polychloroprene medical examination gloves: watertightness test | ASTM D6977-19(2023) 7.3; ASTM D5151-19(2023) | CNAS. IAS: ASTM D6977, ASTM D5151. |
| Single-use medical gloves: watertightness test | EN 455-1:2020+A2:2024 (no clause listed) | CNAS. IAS: EN 455-1, BS EN 455-1. |
| Single-use medical rubber examination gloves: watertightness test | GB 10213-2025 7.2, Annex A | CNAS and CMA (CMA gives no clause); CMA also lists the item under GB 10213-2006 (superseded; see note below). IAS: GB/T 10213, ISO 11193-1 |
| Single-use medical PVC examination gloves: watertightness test | GB 24786-2025 7.2, Annex A | CNAS and CMA (CMA gives no clause); CMA also lists the item under GB 24786-2009 (superseded; see note below). IAS: GB/T 24786 |
| Single-use non-sterile rubber surgical gloves: watertightness test | GB/T 24787-2009 6.2, Annex A | CNAS and CMA (CMA gives no clause). IAS: GB 24787 (as written in the scope) |
IAS lists whole standards without a year; confirm the edition with the laboratory before ordering an IAS report. GB 10213-2025 and GB 24786-2025 are registered on China's national standards platform as GB/T 10213-2025 and GB/T 24786-2025; from 2026-09-01 they replace GB 10213-2006 and GB 24786-2009 in full. Check with the laboratory before ordering a report to the old editions. Full item lists are in our separate GB/T 10213-2025 testing guide.
Where the test is done and under which mark
Glove watertightness testing is done at the Shanghai laboratory at No. 958 Kangqiao East Road, Pudong, Shanghai, operated by Shanghai SUNGO Medical Technology Co., Ltd.
- CNAS accreditation (L22083): all nine rows above; ASTM D5151-19(2023) appears only under the five glove types listed, not other glove materials. The CNAS certificate states that CNAS is a signatory to the ILAC and APAC mutual recognition arrangements.
- IAS accreditation (TL-1019): ASTM D5151, D3578, D6319, D5250 and D6977; EN 455-1 and BS EN 455-1; GB/T 10213, GB/T 24786, GB 24787 and ISO 11193-1, all whole standards without a year. ASTM D3577 is not in the IAS scope, so results based on it cannot carry the IAS mark. The IAS certificate carries the ilac-MRA mark.
- CMA qualification (240015340087): only the national standard items in its schedule: the watertightness tests of GB 10213-2025, GB 24786-2025 and GB/T 24787-2009. The schedule also lists GB 10213-2006 and GB 24786-2009, superseded on 2026-09-01 (see the note above). ASTM and EN standards cannot be reported with the CMA mark. The CMA certificate is valid within the People's Republic of China.
- Hefei laboratory: Hefei SUNGO Medical Technology Co., Ltd. is a separate legal entity, and its scopes include no glove items.
- Biological tests: cytotoxicity, sensitization, irritation and other biological tests are outside this article. Where needed, they 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.
Whether a regulator or buyer accepts a particular report depends on that party's own requirements.
Preparing a submission
- Standard and edition. For example ASTM D5151-19(2023) with the relevant ASTM specification, EN 455-1:2020+A2:2024 or GB/T 10213-2025. List every basis you need; sample size and AQL may differ for each.
- Lot decision rule. The plan in the product specification, or a contractual inspection level and AQL.
- Lot number and lot size. EN 455-1 Clause 7 requires the report to state batch size, sample size and number of non-conforming gloves. EN 455-1 Clause 6 requires a sample size no smaller than the minimum for code letter L (its Note 2: this keeps the assessment adequate for small or unknown lots); ISO 11193-1:2020 assumes 35 001 to 150 000 when lot size cannot be determined.
- One lot. EN 455-1 defines a lot as gloves of the same design, colour, shape, size and formulation, made at essentially the same time with the same process, materials and equipment, in the same type of container, so different sizes are different lots.
- Product details. Material, examination or surgical, sterile or not, sizes and cuff length; agree sectioned filling for long gloves.
- Original packaging. 21 CFR 800.20 has gloves removed carefully from the package and examined visually first, so original packs help record visual defects.
- Separate samples for other items. Inspection levels differ by item (ISO 11193-1:2020 Table 1: S-2 for dimensions and tensile, G-I for watertightness), so sample sizes are calculated separately.
- Report requirements. CNAS, IAS or CMA mark (see above) and report language.
FAQ
Is ASTM D5151 the same as the FDA 1000 mL water leak test?
No. 21 CFR 800.20 is the FDA's regulatory sampling method, and the FDA glove guidance lists it and D5151 as alternatives for assessing barrier integrity. Whether their parameters match should be checked against the D5151 text. SUNGO's scope covers ASTM D5151-19(2023), not 21 CFR 800.20.
We have D5151 results. Do we need EN 455-1 testing for the EU?
A separate EN 455-1 result is advisable: it sets its own water temperature, observation time, long-glove handling and AQL, and Clause 7 specifies report content. See Medical Gloves for the EU: What EN 455 Actually Requires.
Does AQL 1.5 mean 1.5% of gloves may leak?
No. Lot size and inspection level set the sample size, and the AQL sets the acceptance and rejection numbers; the lot fails if leaking gloves in the sample reach the rejection number.
Can a watertightness report carry the CMA mark?
Only for GB 10213-2025, GB 24786-2025 and GB/T 24787-2009; the 2006 and 2009 editions also in the schedule were superseded on 2026-09-01, so check with the laboratory before using them. ASTM D5151 and EN 455-1 are not in the CMA scope; CNAS covers ASTM D5151-19(2023) only for the five glove types listed (nitrile, rubber examination, rubber surgical, PVC, polychloroprene) and EN 455-1 in the 2020+A2:2024 edition. IAS lists whole standards without a year, so confirm the edition before ordering an IAS report.
Will the FDA accept SUNGO's D5151 report?
SUNGO makes no promise about any regulator's decision. Acceptance depends on whether the method, data and traceability meet the regulator's requirements. See also Exporting Medical Gloves to the US: FDA Route and Test Items.
Requesting a quote
Please give the glove material and type (examination or surgical, sterile or not), sizes and cuff length, target market, standards and editions, the inspection level and AQL, lot size, and the report mark and language. The laboratory then plans sample sizes per standard. See medical mask and glove testing, and send quote requests through the contact page.