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  Formula One Latex Exam Gloves
Product Description 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.  
Standards Conformance ASTM D 3578
ASTM D 5151
 Standard Specification for Rubber Examination Gloves
Standard Test Method for Detection of Holes in Rubber Gloves
PackagingSterility:
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:		 K002719
USA
A915463
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. ABSORBABLE DUSTING POWDER, USP, is a micropulverized, modified starch powder.
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-86; Large-103
Small-220; Unisize-230; Large-230
.10
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
CHEMICAL PERMEATION TEST
ASTM F739
Bleach (sodium hypochlorite 5.25%)
Formaldehyde (37%)
Cidex 7 (Glutaraldehyde 2.5%)

PASS
PASS
PASS
VIRAL PENETRATION TEST
ASTM F1671
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
ASTM D 6124		 USP Absorbable Dusting Powder
<70 mg/glove
PROTEIN CONTENT
ASTM ELISA (<10µg/gram of glove)
CHEMICAL ACCELERATORS/
ANTIOXIDANT
Paraphenylenediamine antioxidant:
Zinc dialkyldithiocarbamates:
Mercaptobenzothiazole:
Thiurams

NONE
YES
NONE
NONE
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