Orthopaedic Sterile Latex Surgical Powder Free Glove

Orthopaedic Surgical Glove is designed to provide higher protection during intensive surgeries for prick risk and safety due to its high thickness. This is an alternative to Double Donning Gloves for surgeon whom prefer to wear single glove for better protection. 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. Polymer coated powder free interior enables incredible smooth donning experience.

Colour

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Product Specification

  • Material 

    Natural High Grade Rubber Latex

  • Type

    Latex Surgical Gloves, Powder Free, Polymer Coated

  • Colour 

    Brown

  • 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

    Orthopaedic Surgery

Quality Performance

Functional Benefits

  • Higher thickness offers greater barrier protection during intensive surgeries 
  • Alternative to Double Donning Gloves for surgeon whom prefer to wear single glove
  • Soft inner provides superior comfort to surgeons
  • Fully anatomical design reduces finger fatigue
  • Palm textured enhances slip resistance for extra grip and control 
  • Polymer coating interior enables incredible smooth donning

 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)
  • 5.5
  • 6.0
  • 6.5
  • 7.0
  • 7.5
  • 8.0
  • 8.5
  • 9.0
  • Min 280
  • 72 ± 4
  • 77 ± 5
  • 83 ± 5
  • 89 ± 5
  • 95 ± 5
  • 102 ± 6
  • 108 ± 6
  • 114 ± 6
  • Finger: 0.31 ± 0.02
  • Palm: 0.30 ± 0.02
  • Cuff: 0.22 ± 0.02
 

ASTM D3577

Size Length (mm) Palm width (mm) Thickness : Single wall (mm)
  • 5.5
  • 6.0
  • 6.5
  • 7.0
  • 7.5
  • 8.0
  • 8.5
  • 9.0
  • Min 245
  • Min 265
  • Min 265
  • Min 265
  • Min 265
  • Min 265
  • Min 265
  • Min 265
  • 70 ± 6
  • 76 ± 6
  • 83 ± 6
  • 89 ± 6
  • 95 ± 6
  • 102 ± 6
  • 108 ± 6
  • 114 ± 6
  • Finger: Min 0.10
  • Palm: Min 0.10
  • Cuff: Min 0.10

Tensile Strength (MPa)

  • Before Aging
     
    Min 24
  • After Aging
     
    Min 18

Elongation at Break (%)

  • Before Aging
     
    Min 750
  • After Aging
     
    Min 560

EN 445

Size Length (mm) Palm width (mm) Thickness : Single wall (mm)
  • 5.5
  • 6.0
  • 6.5
  • 7.0
  • 7.5
  • 8.0
  • 8.5
  • 9.0
  • Min 250
  • Min 260
  • Min 260
  • Min 270
  • Min 270
  • Min 270
  • Min 280
  • Min 280
  • 72 ± 4
  • 77 ± 5
  • 83 ± 5
  • 89 ± 5
  • 95 ± 5
  • 102 ± 6
  • 108 ± 6
  • 114 ± 6
  • N/A

Median Force at Break, N 

  • Before Aging
     
    Min 9
  • After Aging
     
    Min 9
 

ISO 10282

Size Length (mm) Palm width (mm) Thickness : Single wall (mm)
  • 5.5
  • 6.0
  • 6.5
  • 7.0
  • 7.5
  • 8.0
  • 8.5
  • 9.0
  • Min 250
  • Min 260
  • Min 260
  • Min 270
  • Min 270
  • Min 270 
  • Min 280
  • Min 280
  • 72 ± 4
  • 77 ± 5
  • 83 ± 5
  • 89 ± 5
  • 95 ± 5
  • 102 ± 6
  • 108 ± 6
  • 114 ± 6
  • Smooth area: Min 0.10
  • Textured area: Min 0.13 

Elongation at Break, %

  • Before Aging
     
    Min 700
  • After Aging
     
    Min 550

Median Force at Break, N

  • Before Aging
     
    Min 12.5
  • After Aging
     
    Min 9.5

Force at 300% Elongation, N

  • Before Aging
     
    Max 2
  • After Aging
     
    N/A
 

Product Safety Conformance

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.

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 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 products. Please liaise with our representative for further details.

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