1/3

Protect Yourself

Protect Others

Latex Surgical Gloves

  • Type : Powdered and Powder-Free, Steril

  • 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

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