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POWDER FREE NITRILE GLOVE

  A good barrier protection against bacteria, viruses, chemicals and dangerous substances.

  An alternative solution for individuals who are allergic to Natural Rubber Latex.

  Free from latex protein, eliminating Type I Immediate Hypersensitivity reaction.

  Custom design enhanced comfort and fit.

  Finger or palm textured enhanced wet and dry grip with added handling precision.

  Chlorinated or polymer powder free interior promote smooth donning & doffing experience.

QUALITY STANDARDS:

  Manufactured under Bureau of Indian standards.

  Manufactured under QSR(GMP), ISO 9001:2015 and ISO 13485:2016 Quality Management System.

  Confirm to ASTM D6319, EN455, ISO 11193 Standards.

  Complies to PPE Regulation (EU) 2016/425 requirements.


Material: Synthetic nitrile latex

Type: Power free, Non Sterile

Design Feature: Finger Textured or Palm Textured Surface, Ambidextrus, Beaded Cuff, Online Single, Clorinated Or Polymer coated

Storage: The gloves shall maintain their properties when stored in dry condition. Avoid direct sunlight

Shelf Life: 5 years from the date of manufacturing

Application: Medical, Healthcare, Dental

Product Safety Conformance

BIOCOMPATIBILITY TESTEDPASS

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
kin Sensitization PASSES
Not a contact sensitizer under condition of the study
CYTOTOXICITY TESTEDPAS

Reference: ISO 10993-5: Test for in vitro Cytotoxicity

Purpose: Biological Evaluation of Medical Device to determine the biological reactivity.

Biocompatibility Test Test Results
Cytotoxicity Test PASSES
Did not shows potential toxicity
This is the format we are expecting
Dimention Small Medium Large
Length (MM) Min 230 Min 235 Min 235
Width(MM) 80 ± 10 95 ± 10 111 ± 10
Thickness(MM)
Finger Min 0.05 Min 0.05 Min 0.05
Palm Min 0.05 Min 0.05 Min 0.05
These are the exact dimensions.

ISO 11193

Size Length (mm) Palm width (mm) Thickness : Single wall (mm)
XS <=80< /td> 70 ± 10
S 80 ± 10
M Min 220 (XS, S) 95 ± 10 Smooth: Min 0.08(>= 3.2 mil)
L Min 230 (M, L, XL) 110 ± 10 Textured: Min 0.11(>= 4.4 mil)
XL >= 110
XXL N/A

Elongation at Break, %

Before Aging

Min

500

After Aging

Min

400

Median Force at Break, N

Before Aging

Min 7

After Aging

Min 6

touch-illustration

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