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| Powder Free Plus Latex Exam Gloves | ||||
| Product Description | Ambidextrous, natural rubber latex non-chlorinated, powder free glove. This glove has passed the modified Draize test on 300 human subjects. Contains less than 50 mcg of total extractable protein per gram. | |||
| Standards Conformance | ASTM D 3578 | Standard Specification for Rubber Examination Gloves | ||
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ASTM D 5151 |
Standard Test Method for Detection of Holes in Rubber Gloves Standard |
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ASTM D 5712 |
Test Method for Analysis of Protein in Natural Rubber and its Products |
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ASTM D 6124 |
Standard Test Method for Residual Powder on Medical Gloves |
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ASTM D 6355 |
Modified Draize Test on Human Subjects |
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| Packaging | Sterility: Packaging: Quantity (inner box): Quantity (outer carton): | Non-Sterile Box board meets requirements of CFR #176.180 100 gloves per box 10 boxes per carton | ||
| FDA Registrations | 510(K) Number: Country of Origin: | K960225 Malaysia | ||
| Quality Assurance Standards | American Society for Testing and Materials (ASTM) | |||
| Materials | Natural Rubber Latex and compounding materials safe for use in medical gloves. Polysiloxane will be applied to the inside only to facilitate donning. | |||
| Conformance to Standards | ASTM D 3578 STANDARD: DIMENSIONS (mm): Width (tolerance +/- 5mm): Length (minimum): Thickness (minimum): Physical Parameters: Minimum Tensile Strength: Minimum Ultimate Elongation: | PASS Small-80; Medium-95; Large-110 Small-220; Medium-230; Large-230 .10mm Unaged or Aged (70° C, 7 days) Unaged - 21MPa, Aged - 16MPa Unaged - 700%, Aged - 500% | ||
| ASTM D 5151 STANDARD WATER LEAK TEST (test for holes) | PASS | |||
| WATERTIGHTNESS, ASTM AQL: | 2.5 | |||
| ASTM F1671 STANDARD VIRAL PENETRATION TEST: | PASS Viral penetration test using a surrogate bacterial virus, PhiX174 bacteriophage. The test is considered to pass when there is no viral penetration through the glove material for at least one hour. | |||
| ASTM Powder Content | <2 mg / glove | |||
| ALLERGEN/PROTEIN CONTENT ASTM Lowry: | < 50 mg / gram of glove | |||
| Chemical Accelerators/ Antioxidant: | Paraphenylenediamine antioxidant: Zinc dialkyldithiocarbamates: Mercaptobenzothiazole (MBT): Thiurams | NONE YES NONE NONE | ||
| Allergen/Protein Content | Protein (µg/gram of glove) Total extractable protein: Lowry: LEAP/ELISA: RAST Inhibition: | LESS THAN 50 LESS THAN 50 LESS THAN 50 LESS THAN 50 | ||
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