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| Dental Care Latex Exam Gloves | ||||
| Product Description | PolyTex® blend lined stretchable exam glove. Ambidextrous, low modulus, soft stretch natural rubber latex gloves which are soft, flexible, non-toxic, seamless, moisture resistant and which will allow a high degree of tactile sensitivity and comfortable fit. This glove has been made with Allotex®, a brand of natural rubber latex that has been enzyme treated to reduce protein antigens. No starch donning powder is added to the glove. | |||
| 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 |
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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 6499 |
Standard ELISA Test Method for Antigenic Proteins |
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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: | K002718 USA A975463 | ||
| Quality Assurance Standards | American Society for Testing and Materials (ASTM) | |||
| Materials | Allotex® natural rubber latex, a brand of natural rubber latex that has been enzyme treated to reduce protein antigens and compounding materials. All will be safe for use in medical gloves. Synthetic latex blend inner layer compounded with approved additives. No starch donning powder added. | |||
| Conformance to Standards PHYSICAL REQUIREMENTS (exam) | ASTM D 3578: DIMENSIONS (mm): Width (tolerance +/- 5mm): Length (minimum): Thickness (minimum): Physical Parameters: Minimum Tensile Strength: Minimum Elongation: | PASS Small-75; Unisize-88; Medium-88; Large-103 Small-220; Unisize-230; Medium-230; Large-240 .10mm Unaged or Aged (70° C, 7 days) Unaged - 14MPa, Aged - 14MPa Unaged - 700%, Aged - 500% | ||
| WATER LEAK TEST (test for holes) ASTM D 5151 (AQL 2.5) | PASS | |||
| Iodine Test for Starch | NONE DETECTED | |||
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ASTM Powder Content |
< 15 mg / glove |
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| ANTIGENIC PROTEIN CONTENT ASTM D 6499 ELISA (µg/gram of glove)  | ||||
| CHEMICAL ACCELERATORS/ ANTIOXIDANT Paraphenylenediamine antioxidant: Zinc dialkyldithiocarbamates: Mercaptobenzothiazole: Thiurams | NONE YES NONE NONE | |||
| BIOCOMPATIBILITY | BIOCOMPATIBLE | |||
| ISO 10993-10 Biological Evaluation of Medical Devices Part 10 | ||||
| Primary Skin Irritation - Rabbit: Primary Irritation Index: Sensitization Study - Guinea Pig: Two (2) - Week Cumulative Irritation Patch Study HUMANS: IRRITATION SCORES: | PASS 0.0 PASS No evidence of causing delayed dermal contact sensitization PASS Total: 0.0, Normalized: 0.0 | |||
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