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| True Advantage Nitrile Exam Gloves | ||||
| Product Description | Ambidextrous poly nitrile blend synthetic gloves which are powder free, flexible, stress relaxing, non-toxic, seamless, moisture resistant and which will allow a high degree of tactile sensitivity. Gloves do not contain any natural rubber latex, accelerators or plasticizers. United States Patents for Elastomeric Covering Material and Hand Glove Made Therewith, for Non Allergenic Medical Devices made from Crosslinked Synthetic Elastomers, No. 5,997,969 issued December 7, 1999. | |||
| Standards Conformance | ASTM D 6319 | Standard Specifications for Nitrile Examination Gloves | ||
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ASTM D 5151 |
Standard Test Method for Detection of Holes in Medical Gloves |
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ASTM D 6124 |
Standard Test Method for Residual Powder on Medical Gloves |
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ASTM F1671 |
Standard Test Method for Viral Penetration (Bacteriophage Biopenetration) |
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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: | K013016 USA | ||
| Quality Assurance Standards | American Society for Testing and Materials (ASTM) | |||
| Materials | Synthetic Nitrile and compounding materials safe for use in medical gloves. | |||
| Conformance to Standards | ASTM D 6319: DIMENSIONS (mm): Width (-/+ 10mm): Length (minimum): Thickness (minimum): Physical Parameters: Minimum Tensile Strength: Minimum Elongation: | PASS Small-70-80; Medium-80-95; Large-95-115; X-Large-120 230 All Sizes .10mm Unaged or Aged (70° C, 7 days) Unaged - 14MPa, Aged - 14MPa Unaged - 500%, Aged - 400% | ||
| WATERTIGHTNESS, ASTM - AQL | 2.5 | |||
| ASTM F1671 STANDARD Viral Penetration Test | PASS Viral penetration using a surrogate bacterial virus, PhiX174 bactriophage. The test is considered to pass when there is no viral penetration through the glove material for at least one hour. | |||
| ASTM F739 STANDARD Chemical Permeation Test: (8 hour study) Formaldehyde (37%) Gluteraldehyde (50%) Cidex 7 (Gluteraldehyde 2.5%) | PASS PASS PASS | |||
| ASTM D5151 STANDARD: Water Leak Test (test for holes): | PASS | |||
| ASTM Powder Content: | < 2mg / glove | |||
| ALLERGEN PROTEIN CONTENT Protein (µg/gram of glove) Residual Protein Content: (Does not contain natural rubber latex proteins) | NONE | |||
| CHEMICAL ACCELERATORS/ ANTIOXIDANT Paraphenylenediamine antioxidant: Zinc dialkyldithiocarbamates: Mercaptobenzothiazole (MBT): Thiurams | NONE NONE NONE NONE | |||
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