Sterile Nitrile Surgical Powder Free Glove

Excellent alternative which eliminates protein allergic reaction and suitable for those who are sensitive to natural rubber latex. 

Colour

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Product Specification

  • Material 

    Synthetic Nitrile

  • Type

    Synthetic Surgical Gloves, Powder Free, Chlorinated

  • Colour 

    White

  • 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

Quality Performance

Functional Benefits

  • Provides an alternative solution for individuals who are allergic to natural rubber latex
  • Appropriate for medical procedures requiring sterility
  • Fully anatomic design to reduce hand fatigue
  • Textured surface for better tactile sensitivity 

 Quality Standards

  • Manufactured under QSR (GMP), ISO 9001:2015 and ISO 13485:2016 Quality Management System
  • Conforms to EN455 standards

 

 

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: 0.15±0.02
  • Palm: 0.13±0.02
  • Cuff: 0.08±0.02
 

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
 

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 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.

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.

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