Surgical Glove – Ascent Care Sdn Bhd

SECTION I : PRODUCT DESCRIPTION

SECTION I : PRODUCT DESCRIPTION
1.1	Type	Latex Surgical Gloves, Powdered, Gamma Sterilized
1.2	Material	Natural High Grade Rubber Latex
1.3	Color	Natural to white and uniform allowing for gradual shift due to thickness variation
1.4	Design and Feature	Anatomical, hand specific, curved fingers and beaded cuff
1.5	Powder	Inside absorbable cornstarch USPXX1
1.6	Storage Condition	- The gloves shall maintain their properties when stored in a dry condition at temperature between 10° to 30° C. - Avoid direct sunlight.
1.7	Shelf-Life	The gloves shall have shelf-life of 5 years from the date of manufacture with the above storage condition.
1.8	Packing Style	1 pair/pouch, 50pouches/box, 4boxes/carton, 1000cartons/20'GP or 2000cartons/40'GP
1.9	Size Marking	The size of gloves shall be marked in the label

SECTION II : PERFORMANCE REQUIREMENTS

SECTION II : PERFORMANCE REQUIREMENTS
(Sampling Plan - ISO 2859 Single Normal)
#	Characteristics	Inspection Level	Acceptable Quality Level	Reference Standard
2.1	Dimensions	Median of 13 test pieces		EN455-2-00
2.2	Physical Properties	Median of 13 test pieces		EN455-2-00
2.3	Freedom from holes (Barrier) (1000ml Water Leak Test)	GI	1.5	EN455-1-00
2.4 (i) (ii)	Visual Defects Major Visual Minor Visual	GI	1.5 2.5	In-house practice
2.5	Powder Amount	N=2	N/A	ASTM D3577-01 ASTM D6124-00
2.6	Protein Content	N=3	N/A	ASTM D3577-01 ASTM D5712-95/99
2.7	Mix Size / Mix Glove / Mix Hand	Not Allowed

SECTION III : PERFORMANCE SPECIFICATION

SECTION III : PERFORMANCE SPECIFICATION
3.1 Dimensions
Property	Size	In-House Standard
Length (mm)	All Sizes	Min 280
Palm Width (mm)	6 6.5 7 7.5 8 8.5 9	77 +/- 5 83 +/- 5 89 +/- 5 95 +/- 5 102 +/- 6 108 +/- 6 115 +/- 5
Thickness (mm) *single wall	All Sizes	Finger : Min 0.17 Palm : Min 0.14 Cuff : Min 0.11
3.2 Physical Properties
Property	In-House Standard
Property	Before Aging	After Aging
Elongation at break (%)	Min 750	Min 560
Tensile Strength (MPa)	Min 24	Min 18
Stress at 500% Elongation (MPa)	Min 5.5	N/A
Median Force at Break (N)	Min 12	Min 9

3.3 Freedom from Holes (Barrier) (1000ml Water Leak Test)
The sample size and allowable number of non-conforming gloves in the samples shall be determined in accordance to Sampling Plan ISO 2859-1 Single Normal using inspection and acceptable quality level as stated in Section II: Performance Requirements.

3.4 Visual Defects
The sample size and allowable number of non-conforming gloves in the samples for both major and minor defects shall be determined in accordance to Sampling Plan ISO 2859-1 Single Normal using Inspection and acceptable quality level as stated in Section II: Performance Requirements.