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| | Sensi Grip Latex Exam Gloves |
| Product Description | Ambidextrous, natural rubber latex gloves which are lightly powdered, flexible, non-toxic, seamless, moisture resistant and which will allow a high degree of tactile sensitivity. | |
| 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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| 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: | K891445 Malaysia | |
| Quality Assurance Standards | American Society for Testing and Materials (ASTM) | |
| Materials | Natural Rubber Latex and compounding materials safe for use in medical gloves. Absorbable Dusting Powder, USP is a micropulverized modified starch powder. | |
| 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%
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| | 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 F739 STANDARD
Chemical Permeation Test:
(8 hour study)
Bleach (sodium hypochlorite 5.25%)
Formaldehyde (37%)
Cidex 7 (Glutaraldahyde 2.5%)
| PASS PASS PASS | |
| | ASTM Lowry | < 200 µg / gram of glove | |
| Chemical Accelerators/ Antioxidant: | Paraphenylenediamine antioxidant: Zinc dialkyldithiocarbamates: Mercaptobenzothiazole (MBT): Thiurams | NONE YES NONE NONE | |
| ASTM Powder Content | USP, Absorbable Dusting Powder | < 70 mg / glove | |
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