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| | Next Generation Stretch Vinyl Exam Gloves Non Latex |
| Product Description | Ambidextrous, polyvinyl chloride (PVC) non-latex, powder free medical grade examination gloves. | |
| Standards Conformance | ASTM D 5250 | Standard Specification for Polyvinyl Chloride Glove | |
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ASTM D 412 |
Standard Test Method for Vulcanized Rubber and Thermoplastic Rubbers and Thermoplastic Elastomers - Tension |
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ASTM D 5151 |
Standard Test Method for Detection of Holes in Medical Gloves |
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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: Device Listing Number: | K992979 People's Republic of China (See Shipment) | |
| Quality Assurance Standards | American Society for Testing and Materials (ASTM) | |
| Materials | Polyvinyl Chloride (PVC) and compounding materials safe for use in medical gloves. No donning powder added. | |
| Conformance to Standards PHYSICAL REQUIREMENTS (exam) | ASTM D 5250-92 STANDARD: DIMENSIONS (mm): Width (tolerance +/- 5mm): Length (minimum): Thickness (minimum): Physical Parameters: Minimum Tensile Strength: Minimum Ultimate Elongation: | PASS
Small-87; Medium-96; Large-108; X-Large-118
Small-240; Medium-240; Large-240; X-Large-240
.10mm
Unaged or Aged (70° C, 7 days)
Unaged - 10MPa, Aged - 10MPa
Unaged - 400%, Aged - 400%
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| | ASTM D 5151 STANDARD WATER LEAK TEST (test for holes) | PASS | |
| | ASTM F739-91 STANDARD CHEMICAL PENETRATION TEST (8 hour study) Bleach (sodium hypochlorite 5.25%) Formaldehyde (37%) Cidex 7 (Glutaraldehyde 2.5%) | PASS PASS PASS | |
| Chemical Accelerators/ Antioxidant: | Paraphenylenediamine antioxidant: Zinc dialkyldithiocarbamates: Mercaptobenzothiazole (MBT)** **HPLC analysis of aqueous extracts: Thiurams | NONE NONE NONE
NONE | |
| Iodine Test for Starch | | None Detected | |
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