Protect Yourself
Protect Others
Latex Surgical Gloves
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Type : Powdered and Powder-Free, Steril
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Material : Natural High Grade Rubber Latex
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Colour : Natural
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Design & Features : Hand specific, curved fingers, palm textured, beaded cuff
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Sterilization : Gamma Ray or EtO
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Storage : The gloves shall maintain their properties when stored in a dry condition. Avoid direct sunlight
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Shelf-life : 5 years from the date of manufacturing
FUNCTIONAL BENEFITS
· Extra strength provides additional protection from surgical debris
· Fully anatomical design to reduce hand fatigue
· Softness provides superior comfort and natural fit
· Micro-roughened palm surface provides excellent wet and dry grip · Beaded cuff makes donning easy and helps prevent roll back
· High strength and elasticity
QUALITY STANDARDS
· Conforms to ASTM D3577 and EN455 Standards
· Manufactured under QSR (GMP), ISO 9001:2015 and ISO 13485:2016 Quality Management System
· Using USP grade absorbable cornstarch
· Sterilized by Gamma Ray Irradiation or EtO
· Bioburden and sterility tested
GLOVE SIZES
· 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 Size of gloves shall be marked in the check box
on the shipping carton with black ink
PRODUCT SPECIFICATION
SIZE
6.0
6.5
7.0
7.5
8.0
8.5
9.0
PALM WIDTH +/-5mm
76
83
89
95
102
108
114
LENGTH+/-5mm
265
265
275
275
275
285
285
PHYSICAL PROPERTY MIN
Tensile Strength
Elongation
Before Aging 24 Mpa
750%
After Aging 18 Mpa
560%
Watertight Test
<=AQL1.5
Quality standards：Meets ASTM, EN, JIS, AS Manufactured in accordance
with ISO 13485 systems.
TESTED
Property
Test Results
Primary Skin Irritation
Passes
Not a primary skin irritant under condition of the study
Skin Sensitization
Passes
Not a contact sensitizer under condition of the study
1) BIOCOMPATIBILITY TESTED
Reference : ISO 10993-10 (Test for Skin Irritation and Skin Sensitization)
Purpose : Biological evaluation for medical devices for irritation and delayed type hypersensitivity
2) STERILITY TESTED
Purpose : To check the presence of bacterial in gloves after sterilization process
Sterility Test
Test Results
Passes
Remarks: Applicable to selected products. Please liaise with our representative for further details
3) BACTERIAL ENDOTOXIN TESTED
Purpose : To check the presence of bacterial in gloves and it can cause variety of inflammatory responses if enough of their molecules get in the bloodstream
Bacteria Endotoxin
Test Results
Passes
Remarks: Applicable to selected products. Please liaise with our representative for further details
4) VIRAL PENETRATION TESTED
Reference : ASTM F1671 - Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood - Borne Pathogens Using Phl-X 174 Bacteriophage Penetration as a Test System
Purpose : To test the barrier protection of the gloves from the passages of the viruses
Viral Penetration
Test Results
Passes
Remarks: Applicable to selected products. Please liaise with our representative for further details
5) CLINICAL EVALUATION TESTED
Purpose: To test the efficiency and safety of glove usage
Clinical Evaluation
Test Results
Passes
Remarks: Applicable to selected products. Please liaise with our representative for further details
6) BIOBURDEN TESTED
Purpose: To test the numbers of bacterial living on the glove's surface that has not been sterilized
Bioburden
Test Results
Passes
Remarks: Applicable to selected products. Please liaise with our representative for further details
7) CHEMICAL RESIDUE TESTED
Purpose: To ensure gloves are free from any chemical substances
Chemical Test (s)
Test Results (μg/g)
Butylated Hydroxyanisole (BHA)
Not Detected
Butylated Hydroxytoluene (BHT)
Not Detected
Diphenyl Guanidine (DPG)
Not Detected
Diphenyl Thiourea (DPT)
Not Detected
Mercaptobenzothiazole (ZMBT)
Not Detected
Zinc Mercaptobenzothiazole (ZMBT)
Not Detected
Tetramethylthiuram Disulphide (TMTD)
Not Detected
Zinc Dibutyldithiocarbamate (ZDBC)
Not Detected
Zinc Diethyldithiocarbamate (ZDEC)
Not Detected
Zinc Dimethyldithiocarbamate (ZDMC)
Not Detected
Zinc Mercaptobenzimidazole (ZMBI)
Not Detected
Zinc Pentamethyleneditithiocarbamate (ZPMC)
Not Detected
Remarks: Applicable to selected products. Please liaise with our representative for further details