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  Formula One Sterile 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 Standard Specification for Rubber Examination Gloves
ASTM D 5151
Standard Test Method for Detection of Holes in Rubber Gloves
ANSI/AAMI/ISO 11135
Sterilization Specification - Ethylene Oxide
Packaging Sterility:
Sterility Method:
Sterility Assurance Level
 Sterile
Ethylene Oxide (ETO)
10 (-6)
  
Sterile Packaging,
Inner Wrap		 Bleached crepe kraft paper marked appropriately for orientation. Printed on both sides are the words "unfold to expose flap" and directly beneath this is an arrow pointing upward on one side and downward on the other.
Sterile Packaging,
Outer Wrap		 The Innerwrap (Singles or Pairs) will be placed in a peelable, non-resealable, cold sealed outer package at the same time of packaging. The face of the outer package will be imprinted with the size of glove inside innerwrap and the reorder number. The back of each package will be imprinted with the lot number for traceability.
Inner Box Strength:
Outer Carton Strength:		 175 lb. test
200 lb. test
Sterile Packaging
Inner Box:
Outer Carton:
100 packages of singles or 50 packages of pairs
8 inner boxes
FDA Registrations 510(K) Number:
Country of Origin:
Device Listing Number:		 K002720
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 as 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 Test
 <70 mg/glove
ANTIGENIC PROTEIN CONTENT
ASTM D 6499 ELISA (µg/gram of glove)
CHEMICAL ACCELERATORS/
ANTIOXIDANT
Paraphenylenediamine antioxidant:
Zinc dialkyldithiocarbamates:
Mercaptobenzothiazole (MBT):
Thiurams

NONE
YES
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NONE
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