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.
Optional Tests for Gloves Tests
Glove viral penetration ASTM F1671, PB70
This test procedure is used for evaluating the viral penetration resistance characteristics of gloves. This test procedure was designed to comply with the ASTM F1671 procedure developed by ASTM Subcommittee F23.40 on Biological Hazards. The test device used in this procedure is the ASTM F903 Chemical Penetration Cell.
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.
LAL Test: Gloves ASTM
The Limulus amebocyte lysate (LAL) test is an vitro assay for detection and quantitation of bacterial endotoxin. Validated test methods performed at Nelson Laboratories includes the gel clot technique and the kinetic turbidimetric and chromogenic (colorimetric) assays.
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.
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.
