The ASTM D6319-99 issued by the U.S. FDA and China’s GB10213 are commonly used standards for testing medical nitrile gloves in China. These standards specify inspection items, technical requirements, and pass/fail criteria, providing essential guidelines for nitrile glove testing. Below is an introduction to the sampling plan for nitrile glove testing.
Sampling Plan
Nitrile examination gloves are typically packaged in boxes of 100 gloves, with 10 boxes per carton, and 1,000–1,200 cartons per 20-foot container for export.
The number of test samples is determined based on the inspection level of each test item, ensuring both representativeness of the batch and compliance with testing requirements. For a 20-foot container of nitrile examination gloves, 32 cartons should be sampled. If the batch size is less than 500 cartons, the actual number of cartons can be used to determine the sampling quantity by referencing standard tables.
Some clients may adopt alternative inspection methods, such as sampling 5 cartons per glove size and then randomly selecting 2 full boxes from each carton for testing. While this method is relatively simple, there is currently no official documentation supporting its validity.
Testing Content
- Physical Performance Testing
Abrasion Resistance Test: Includes tensile strength and elongation tests. Specialized machines measure the material’s tensile strength and maximum elongation to evaluate tear resistance.
- Chemical Performance Testing
Tests resistance to oil, acids, alkalis, etc., ensuring the gloves provide effective hand protection in various chemical environments.
- Pinhole Detection Test
A common method uses a water leak tester, where a sample of gloves is filled with water to determine the leakage rate, indicating the batch’s compliance.
- Safety Level Testing
Measures chemical residues on the glove surface, such as vulcanizing agents, plasticizers, unreacted acrylonitrile, or butadiene monomers. Excessive levels may pose long-term health risks to users.
The above covers the testing content and sampling plan for nitrile gloves. For more information, please do not hesitate to contact us.
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