PRODUCT SPECIFICATIONS
Product Specs
Non-Sterile Powder-Free Nitrile Examination Glove
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1.0. PRODUCT INFORMATION |
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1.1 |
Trade Name |
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Non-Sterile Powder-Free Nitrile Examination Glove |
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1.2 |
Design and Feature |
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Ambidextrous, beaded cuff, smooth, finger texture, polymer coated |
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1.3 |
Product Classification |
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FDA: 80LZA-880.6250, MDD : Class I |
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1.4 |
Intended Use |
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Medical use for medical examination and procedure to help prevent contamination between healthcare workers and patients |
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1.5 |
Product conformance |
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Meet current version of ASTM D 6319 and EN-455: Part 1, 2, 3, 4 |
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1.6 |
Material |
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Carboxylated Acrylo-Nitrile Butadiene Rubber (XNBR) |
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1.7 |
Donning Aid |
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Acrylic Polymer |
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1.8 |
Color |
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Blue -SB |
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1.9 |
Storage Condition |
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Product shall be stored under room condition avoid direct sunlight |
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1.10 |
Shelf life |
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3 years from the date of manufacture with the above storage condition |
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2.0. PHYSICAL DIMENSION (ASTM D 6319 & EN 455) AND GLOVE WEIGHT |
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2.1 |
Glove size |
XS |
S |
M |
L |
XL |
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2.2 |
Width (mm) |
75 ± 5 |
85 ± 5 |
95 ± 5 |
105 ± 5 |
115 ± 5 |
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2.3 |
Length (mm) |
Min. 240 |
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2.4 |
Glove Weight |
3.5 ± 0.2g – M Size (For Reference only) |
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2.5 |
Glove Thickness (mm) |
0.06 ± 0.02 |
0.08 ± 0.02 |
0.09 ± 0.02 |
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3.1. PHYSICAL PROPERTIES (ASTM D 412) |
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Before Aging |
After Aging |
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Tensile Strength (Mpa) |
Elongation at break (%) |
Tensile Strength (Mpa) |
Elongation at break (%) |
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Min. 14 |
Min. 500 |
Min. 14 |
Min. 400 |
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3.2. PHYSICAL PROPERTIES (ASTM D 412) |
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Before Aging |
After Aging |
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Tensile Strength (N) |
Elongation at break (%) |
Tensile Strength (N) |
Elongation at break (%) |
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Median ≥ 6N |
nil |
Median ≥ 6N |
nil |
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4.0. RESIDUAL POWDER CONTENT (ASTM D 6124) : Less than 2.0mg/glove |
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5.0. PACKING METHOD : Packing by weight |
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6.0. PERFORMANCE AND CONFORMANCE |
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Inspection & Testing Method |
Quality Criteria |
Inspection Level |
AQL |
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6.1 |
Watertight Test (ASTM D 5151) |
Holes |
GI |
1.5 |
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6.2 |
Visual Inspection (Internal) |
Major Defects |
GI |
2.5 |
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6.3 |
Visual Inspection (Internal) |
Minor Defects |
GI |
4.0 |
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6.4 |
Physical Properties(ASTM D 412, ASTM D 6319, EN 455-2) |
Tensile Strength & Elongation |
S-2 |
4.0 |
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6.5 |
Physical Dimension (ASTM D 6319, EN 455) |
Measurement |
S-2 |
4.0 |
Non-Sterile Powder-Free Nitrile Disposable Glove
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1.0. PRODUCT INFORMATION |
|||
|
1.1 |
Trade Name |
: |
Non-Sterile Powder-Free Nitrile Disposable Glove |
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1.2 |
Design and Feature |
: |
Ambidextrous, beaded cuff, smooth, finger texture, polymer coated |
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1.3 |
Product Classification |
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FDA: 80LZA-880.6250, MDD : Class I |
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1.4 |
Intended Use |
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For protection of the user as a physical barrier against brief contact with chemicals. |
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1.5 |
Product conformance |
: |
Meet current version of ASTM D 6319 and EN-455: Part 1, 2, 3, 4 |
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1.6 |
Material |
: |
Carboxylated Acrylo-Nitrile Butadiene Rubber (XNBR) |
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1.7 |
Donning Aid |
: |
Acrylic Polymer |
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1.8 |
Color |
: |
Blue -SB |
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1.9 |
Storage Condition |
: |
Product shall be stored under room condition avoid direct sunlight |
|
1.10 |
Shelf life |
: |
3 years from the date of manufacture with the above storage condition |
|
2.0. PHYSICAL DIMENSION (ASTM D 6319 & EN 455) AND GLOVE WEIGHT |
||||||
|
2.1 |
Glove size |
XS |
S |
M |
L |
XL |
|
2.2 |
Width (mm) |
75 ± 5 |
85 ± 5 |
95 ± 5 |
105 ± 5 |
115 ± 5 |
|
2.3 |
Length (mm) |
Min. 240 |
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|
2.4 |
Glove Weight |
3.5 ± 0.2g – M Size (For Reference only) |
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2.5 |
Glove Thickness (mm) |
0.07 ± 0.02 |
0.08 ± 0.02 |
0.09 ± 0.02 |
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|
3.1. PHYSICAL PROPERTIES (ASTM D 412) |
|||
|
Before Aging |
After Aging |
||
|
Tensile Strength (Mpa) |
Elongation at break (%) |
Tensile Strength (Mpa) |
Elongation at break (%) |
|
Min. 14 |
Min. 500 |
Min. 14 |
Min. 400 |
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3.2. PHYSICAL PROPERTIES (EN 455-2) |
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Before Aging |
After Aging |
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|
Tensile Strength (N) |
Elongation at break (%) |
Tensile Strength (N) |
Elongation at break (%) |
|
Median ≥ 6N |
nil |
Median ≥ 6N |
nil |
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4.0. RESIDUAL POWDER CONTENT (ASTM D 6124) : Less than 2.0mg/glove |
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5.0. PACKING METHOD : Packing by weight |
|||
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6.0. PERFORMANCE AND CONFORMANCE |
||||
|
|
Inspection & Testing Method |
Quality Criteria |
Inspection Level |
AQL |
|
6.1 |
Watertight Test (ASTM D 5151) |
Holes |
GI |
1.5 |
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6.2 |
Visual Inspection (Internal) |
Major Defects |
GI |
2.5 |
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6.3 |
Visual Inspection (Internal) |
Minor Defects |
GI |
4.0 |
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6.4 |
Physical Properties(ASTM D 412, ASTM D 6319, EN 455-2) |
Tensile Strength & Elongation |
S-2 |
4.0 |
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6.5 |
Physical Dimension (ASTM D 6319, EN 455) |
Measurement |
S-2 |
4.0 |
Features and Benefits
- Beaded for easing donning and prevents rollback
- Soft and comfortable on the hands
- Good elasticity to reduce hand fatigue
- Finger textured for better grip
- Low chemical residue
- Powder free – reduces allergic reaction
- Superior puncture and tear resistance properties
- Non sterile Single Use
Complying to
- EN 455 1-4
- ASTM D6319