Specification builder · Tier A
Glove water-leak (freedom from holes) test rig for medical examination and surgical gloves, with 1000 mL filling, multi-station hanging rig, timers and glove dimension/thickness accessories
A glove water-leak tester is a multi-station rig on which each sampled glove is clamped to a clear cylinder and filled with 1000 mL of water, then checked for leaks (immediately and again after 2 minutes under 21 CFR 800.20; EN 455-1 and ASTM D5151 use the same 1000 mL fill). Drug and device testing laboratories, glove makers and importers, and procurement testing labs in Pakistan use it to accept or reject glove lots against the AQL of the product standard. It is simple apparatus, often bought as a few ready-made units or a bidder-built bench, with glove length, width and thickness tools and an optional air-inflation screening test.
What this equipment will do
- Glove types: single-use medical examination gloves (ISO 11193-1, EN 455-1) and sterile surgical gloves (ISO 10282, EN 455-1).
- Extra-small and small gloves and extended-cuff surgical gloves, using smaller and longer filling cylinders. (with the optional module)
- Freedom from holes: 1000 mL water-leak test with leak checks immediately and 2 minutes after filling (21 CFR 800.20, ASTM D5151).
- Water-tightness (freedom from holes) test of EN 455-1, and the watertightness annexes of ISO 11193-1 and ISO 10282 (Annex B).
- Several gloves tested at the same time on a multi-station hanging rig (not less than 5 stations; 10 or 20 with the larger rigs).
- Lot accept/reject from the sample size and acceptance number for the AQL and inspection level (ISO 2859-1, 21 CFR 800.20).
- Test water kept at 20-30 deg C as 21 CFR 800.20 requires, even in hot weather. (with the optional module)
- Test-water temperature recorded with a calibrated thermometer for every test. (with the optional module)
- Glove length and palm width (ISO 11193-1, ISO 10282 Annex A, EN 455-2). (with the optional module)
- Glove film thickness at the specified measuring points (ISO 10282 Annex A, ISO 23529). (with the optional module)
- Air-inflation screening test for quick checks (with reference to EN ISO 374-2); screening only, not accepted for DTL or referee results. (with the optional module)
Not covered: Containment gloves on isolator or glovebox ports are not tested here; they need a glove port pressure-decay integrity tester.; Glove tensile strength (force at break) and elongation, before and after ageing (EN 455-2, ISO 11193-1, ISO 10282), need the universal testing machine and an ageing oven.; Powder content, extractable protein (latex allergen) and viral or blood penetration barrier tests need chemistry and specialised barrier-test equipment.; Sterility of surgical gloves needs the sterility testing set-up (isolator, pump and manifold).
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Standards this specification draws on
- EN 455-1:2020+A2:2024 European requirement and test method for freedom from holes of single-use medical gloves (1000 mL water-tightness test with referee and routine testing, ISO 2859-1 sampling and AQL); Amendment 2 approved by CEN in August 2024.
- ASTM D5151-19(2023) ASTM reference test method for detection of holes in medical gloves by water leakage, cited by the ASTM glove specifications and FDA.
- 21 CFR 800.20 US FDA rule giving the 1000 mL water-leak test apparatus (60 x 380 mm clear cylinder, 40 mm mark, hook and hanging rod), water at 20-30 deg C, checks immediately and 2 minutes after filling, and the sampling plans and AQLs for examination and surgeon's gloves.
- ISO 11193-1:2020 ISO specification for rubber medical examination gloves; its watertightness test annex and dimension requirements are used for exam-glove testing.
- ISO 10282:2023 ISO specification for sterile rubber surgical gloves; Annex A covers length, width and thickness measurement and Annex B the watertightness test.
- EN 455-2:2024 European requirements and tests for physical properties and dimensions of medical gloves (length, width).
- ISO 2859-1:1999 Sampling procedures for inspection by attributes; sets sample sizes and accept/reject numbers for the AQL-based leak test.
- EN ISO 374-2:2019 Air-leak and water-leak tests for protective gloves (same 1000 mL, 60 x 380 mm cylinder water apparatus); reference for the air-inflation option.
- IEC 61010-1 Electrical safety standard for laboratory equipment; applies to powered dispensers, timers, lighting and compressors.
- IEC 61326-1 EMC requirements for electrical laboratory equipment.
- ISO/IEC 17025:2017 Accreditation standard for testing and calibration labs; requires calibrated, traceable volume, time, temperature and dimension measurements.
Common mistakes in tenders for this equipment
- Specifying a 'glove integrity tester' for isolator or glovebox ports (pressure-decay testers for containment gloves) when the lab needs the 1000 mL water-leak rig for medical examination and surgical gloves.
- Accepting an air-inflation tester as a substitute for the 1000 mL water-leak test required by EN 455-1, ASTM D5151 and 21 CFR 800.20.
- Copying one maker's brochure (exact station count in one frame, frame size, touchscreen layout) so only that maker complies; state minimum stations (allowing several units), volume accuracy and timer accuracy instead.
- Leaving out water temperature control and a thermometer, so in summer the test runs above 30 deg C and results fall outside the method.
- Leaving out the glove length/width fixture, thickness gauge and accredited calibration certificates, so the lab cannot issue a complete glove test report.
- Using wrong sampling: testing a fixed 10 or 20 gloves per lot instead of the ISO 2859-1 sample size and acceptance number for the AQL and inspection level in the product standard.
- Asking for DRAP medical-device registration of the test rig itself; it is laboratory equipment, and the demand only confuses bidders.