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LATEX SURGICAL GLOVE

Type
  • Powdered and Powder-Free, Sterile
Material
  • Natural High Grade Rubber Latex
Colour
  • Natural
Design & Features
  • Hand specific, curved fingers, palm textured, beaded cuff
Sterilization
  • Gamma Ray or EtO
Storage
  • The gloves shall maintain their properties when stored in a dry condition. Avoid direct sunlight
Shelf-life
  • 5 years from the date of manufacturing

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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

International Quality System Certificate Awarded:


Dimension Standard
Top Glove ASTM D3577 EN 445
Length (mm)
Min 280 Min 245 (5.5)
Min 265 (6.0 to 9.0)
Min 250 (5.5)
Min 260 (6.0 to 6.5)
Min 270 (7.0 to 8.0)
Min 280 (8.5 to 9.0)
Palm Width (mm)
5.5
6.0
6.5
7.0
7.5
8.0
8.5
9.0

72 +/- 4
77 +/- 5
83 +/- 5
89 +/- 5
95 +/- 5
102 +/- 6
108 +/- 6
114 +/- 6

70 +/- 6
76 +/- 6
83 +/- 6
89 +/- 6
95 +/- 6
102 +/- 6
108 +/- 6
114 +/- 6

72 +/- 4
77 +/- 5
83 +/- 5
89 +/- 5
95 +/- 5
102 +/- 6
108 +/- 6
114 +/- 6
Thickness : Single Wall (mm)
5.5
6.0
6.5
7.0
7.5
8.0
8.5
9.0

Cuff: Min 0.10
Palm: Min 0.10
Finger: Min 0.10
N/A
Property ASTM D3577 EN 455
Tensile Strength (MPa)
Before Aging
After Aging

Min 24
Min 18

N/A
N/A
Elongation at Break (%)
Before Aging
After Aging

Min 750
Min 560

N/A
N/A
Median Force at Break (N)
Before Aging
After Aging

N/A
N/A

Min 9
Min 9

1.1) 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

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


1.2) 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.


1.3) 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.


1.4) 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.


1.5) 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.


1.6) 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.


1.7) 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.