Sterile Latex Surgical Powdered Glove
Latex Surgical Glove is known for it's elasticity and softness that not only provide great biological barier protection but also fit, comfort, dexterity and flexibility. Fully anatomical design with curved fingers follow the natural finger shapes at rest provides free range motion and minimises hand fatigue during surgical procedure. Palm textured surface enhances slip resistance for extra grip and control. The evenly distributed lightly powdered at the donning side promotes efficient donning and doffing.
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Product Specification
- Material
Natural High Grade Rubber Latex
- Type
Latex Surgical Gloves, Powdered with USP Grade Absorbable Corn Starch
- Colour
Natural
- Design & Features
Hand specific, curved fingers, palm textured, beaded cuff.
- Glove Size
5.5 to 9.0
- Sterilization
Yes
- Storage
The gloves shall maintain their properties when stored in a dry condition. Avoid direct sunlight
- Shelf Life
The gloves shall have shelf life of 5 years from the date of manufacture
- Application
General Surgery
Functional Benefits
Functional Benefits
- Optimum choice for general surgical operations
- Elasticity and softness provide fit, comfort, dexterity & flexibility
- Fully anatomical design reduces finger fatigue
- Palm textured enhances slip resistance for extra grip and control
- Lightly powdered interior promotes easy donning & doffing
- Beaded cuff makes donning easy and helps prevent roll back
Quality Standards
- Manufactured under QSR (GMP), ISO 9001:2015 and ISO 13485:2016 Quality Management System
- Conforms to ASTM D3577, EN455 and ISO 10282 standards
- Complies to PPE Regulation (EU) 2016/425 requirements
Physical Dimension & Physical Properties
TOP GLOVE
| Size | Length (mm) | Palm width (mm) | Thickness : Single wall (mm) | ||
|---|---|---|---|---|---|
| LSGPW | SLPE 9.6g | SLP 9.7g | |||
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| Size | Length (mm) | Palm width (mm) | Thickness : Single wall (mm) | ||||||
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| S290 | S290 | S290 | |||||||
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ASTM D3577
| Size | Length (mm) | Palm width (mm) | Thickness : Single wall (mm) |
|---|---|---|---|
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Tensile Strength (MPa)
- Before AgingMin 24
- After AgingMin 18
Elongation at Break (%)
- Before AgingMin 750
- After AgingMin 560
EN 455
| Size | Length (mm) | Palm width (mm) | Thickness : Single wall (mm) |
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Median Force at Break, N
- Before AgingMin 9
- After AgingMin 9
ISO 10282
| Size | Length (mm) | Palm width (mm) | Thickness : Single wall (mm) |
|---|---|---|---|
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Elongation at Break, %
- Before AgingMin 700
- After AgingMin 550
Median Force at Break, N
- Before AgingMin 12.5
- After AgingMin 9.5
Force at 300% Elongation, N
- Before AgingMax 2
- After AgingN/A
Product Safety Conformance
CHEMICAL RESIDUE TESTED Pass
Purpose: To ensure the gloves are free from any chemical substances and safe to use.
| 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 (MBT) | 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 Mercaptobenzothiazole (ZMBT) | Not Detected |
| Zinc Pentamethyleneditithiocarbamate (ZPMC) | Not Detected |
Remark: Applicable to selected product. Please liaise with our representative for further details.
VIRAL PENETRATION TESTED Pass
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 |
Remark:Applicable to selected products. Please liaise with our representative for further details.
STERILITY TESTED Pass
To check the presence of bacterial in gloves after sterilization process.
Remark: Applicable to selected products. Please liaise with our representative for further details.
BIOBURDEN TESTED Pass
To test the numbers of bacterial living on the glove’s surface that has not been sterilized.
| Bioburden | Test Result |
|---|---|
| PASSES |
Remark: Applicable to selected products. Please liaise with our representative for further details.
BACTERIAL ENDOTOXIN TESTED Pass
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.
Remark: Applicable to selected products. Please liaise with our representative for further details.
BIOCOMPATIBILITY TESTED Pass
Reference:ISO 10993-10 (Test for Skin Irritation and Skin Sensitization)
Purpose: Biological evaluation for medical devices for irritation and delayed type hypersensitivity.
| Biocompatibility Test | 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 |
Remark: Applicable to selected product. Please liaise with our representative for further details.
PHTHALATES TESTED Pass
Purpose: Compliance on REACH Regulation (EC) 1907/2006 Annex XVII requirements for phthalates
| Chemical Test (s) | Test Results (μg/g) |
|---|---|
| Dibutyl Phthalate (DBP) | Not Detected |
| Di(2-ethylhexyl) Phthalate (DEHP) | Not Detected |
| Di-n-octyl Phthalate (DNOP) | Not Detected |
| Di-isononyl Phthalate (DINP) | Not Detected |
| Di-isodecyl Phthalate (DIDP) | Not Detected |
| Benzyl butyl Phthalate (BBP) | Not Detected |
Remark: Applicable to selected product. Please liaise with our representative for further details.
