Gloves Tests
Nelson Laboratories conducts the testing of medical glove. These methods are valuable in characterizing all types of medical gloves in accordance with specific ASTM standards and FDA guidance documents. The test results can be used in support of 510(K) submission, materials files, and lot release quality control.
Note: As of 19 Dec 2008 the AQl adulteration levels for both surgical and examination gloves have been tightened. Now for surgical level the AQL adulteration level is 1.5 and for patient examination level is 2.5. Additional information about the new ruling can be read at the end by downloading now.
Optional Tests for Gloves Tests
Tensile test, elastomeric materials ASTM D412
Fabrics are tested by the strip method (ASTM D5035) or the grab test (ASTM D5034). Plastics are tested according to ASTM D882, ASTM D638, and ASTM D412.
Whole glove viral barrier study
This outline details procedures for evaluation of the barrier properties of covers/sheaths or gloves. A simulated probe is placed in the covers. The covers are suspended in a container filled with sterile solution and then filled with a suspension of the challenge virus Phi-X174 at a concentration ≥108 plaque forming units (PFU) per mL. The covers will be agitated throughout the challenge procedure on an orbital shaker operated at 100-125 revolutions per minute (rpm). Shaking will be performed at 37 ± 2°C to simulate clinical use conditions. The external liquid will be assayed for the challenge virus Phi-X174 using plaque assay techniques at each of the following time intervals: 0 and 60 minutes. Positive, negative, and percent recovery controls will be included in the test.
Glove IPA degradation test NFPA 1999
Current FDA expectations for patient examination gloves ASTM D3578, medical surgical gloves ASTM D3577 and PVC gloves ASTM D5250 include adherence to these ASTM standards as well as the NFPA 1999 standard for physical properties.
Glove heat aging degradation test ASTM D573, NFPA 1999
Current FDA expectations for patient examination gloves ASTM D3578, medical surgical gloves ASTM D3577 and PVC gloves ASTM D5250 include adherence to these ASTM standards as well as the NFPA 1999 standard for physical properties.
Evaluation of Leakage in Gloves ASTM5151
Evaluation of Leakage in Gloves ASTM 5151
Glove Puncture Resistance ASTM F1342
This test method determines the puncture resistance of a material specimen by measuring the force required to cause a sharp-edged puncture probe to penetrate through the specimen. This test method is covered as defined in ASTM F1342.
Glove test, residual powder, aged ASTM D6124
Glove test, residual powder, unaged ASTM D6124
Glove physical dimensions ASTM D3578-91, ASTM D573, ASTM D5250
Current FDA expectations for patient examination gloves ASTM D3578, medical surgical gloves ASTM D3577 and PVC gloves ASTM D5250 include adherence to these ASTM standards as well as the NFPA 1999 standard for physical properties.
Glove tensile test, aged ASTM D3578
Glove tensile test, unaged ASTM D3578
Current FDA expectations for patient examination gloves ASTM D3578, medical surgical gloves ASTM D3577 and PVC gloves ASTM D5250 include adherence to these ASTM standards as well as the NFPA 1999 standard for physical properties.
MEM Elution and pH for gloves ISO 10993-5, USP 87
This cytotoxicity test using mammalian cell culture media (MEM) demonstrates the cytotoxic effect of the sample/product submitted for testing. Samples are placed in contact with a monolayer of L-929 or other appropriate layer of cells and incubated. The cells are then scored for cytopathic effect.
