NITRILE MEDICAL GLOVES

TYPE
Powdered & Powder-Free, Non-sterile
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Our Specifications

FUNCTIONAL BENEFITS

 
  • Protection from unwanted and dangerous substances
  • Beaded cuff ensures easy donning to prevent roll down
  • Superior strength with better puncture resistance
  • Finger or palm textured enhanced wet and dry grip
  • Thinner gauge improves tactile sensitivity
  • Custom design enhanced comfort and fit
  • An alternative solution for individuals with allergies to natural rubber latex
 

QUALITY STANDARDS

  • Conforms to ASTM D6319 and EN 455 Standards
  • Manufactured under QSR (GMP), ISO 9001:2015 and ISO 13485:2016 Quality Management System

GLOVE SIZES

  • Extra-Small, Small, Medium, Large, Extra-Large
  • Size of gloves shall be marked in the check box on the shipping carton with black ink
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PHYSICAL DIMENSION
 
 
Dimension
Mediblue
ASTM D6319
EN 455
Length (mm)
Min 230
Min 240 or
300 +/- 10
Min 220 (XS, S)
Min (M, L, XL)
Min 240
Palm Width (mm)
XS
S
M
L
XL
76 +/-3
84 +/-3
94 +/-3
105 +/-3
113 +/-3
70 +/- 10
80 +/- 10
95 +/- 10
110 +/- 10
120 +/- 10
≤ 80
80 +/- 10
95 +/- 10
110 +/- 10
≥ 110
Thickness : Single Wall (mm)
Finger
Palm
Min 0.05
Min 0.05
Min 0.05
Min 0.05
N/A
N/A
 
PHYSICAL PROPERTIES
 
Property
ASTM D6319
EN 455
Tensile Strength (MPa)
Before Aging
After Aging
Min 14
Min 14
N/A
N/A
Elongation at Break (%)
Before Aging
After Aging
Min 500
Min 400
N/A
N/A
Median Force at Break (N)
Before Aging
After Aging
N/A
N/A
Min 6
Min 6
PRODUCT SAFETY CONFORMANCE
1.1) BIOCOMPATABILITY 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) VIRAL PENETRATION TESTED

Reference: ASTM F1671 - Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood - Borne Pathogens Using Phi-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
Remarks: Applicable to selected products. Please liaise with our representative for further details.
Passes
1.3) HEAVY METAL TESTED

Purpose: To ensure gloves are free from any chemical substances
Chemical Test (s)
 
Test Results (mg/kg)
 
 
Cadmium (Cb)
 
Not Detected
Lead (Pb)
Not Detected
Mercury (Hg)
Not Detected
Arsenic (As)
Not Detected
Antimony (Sb)
Not Detected
Tin (Sin)
Not Detected
 
1.4) CHEMICAL RESIDUE TESTED

Purpose: To ensure gloves are free from any chemical substances
 
 
Chemical Test (s)
 
 
Test Results (mg/kg)
 
 
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
 
Remarks: Applicable to selected products. Please liaise with our representative for further details.

Contact MediBlue today for a quotation

The trusted market name for premium quality Nitrile Gloves