Awintoo Medical Nitrile Gloves for your Safety First:
Medical Gloves a concise statement / summary:
Lets get through the material properties, Physical Characteristic & Ingredient of Nitrile Gloves. But before that we must compare Nitrile & Latex with other materials.
Properties of materials used in medical glove manufacture:-
(MATERIAL - ORIGIN - PROPERTIES - USE)
A] Natural Latex : Natural extract of rubber tree Hevea brasiliensis. Excellent fit and feel, but potentially allergenic. Used for Surgical gloves, examination gloves,
B] Synthetic Rubber : Polychloroprene or synthetic polyisoprene. Excellent fit and feel. Used for Surgical gloves, examination gloves.
C] Nitrile : Polymer of butadiene with acrylonitrile. High strength and chemical protection, good elasticity. Used as Examination gloves, surgical gloves.
D] Neoprene : Polymers of chloroprene (2-chloro-I, 3-butadiene). Good fit and feel comfortable. For Examination gloves, surgical gloves
E] Vinyl : Polyvinyl chloride (PVC), polymer of vinyl chloride monomer. This are Poor elasticity and poor chemical resistance. For Examination gloves (short-term procedures) very limited use.
Thus, Medical use Nitrile examination gloves are suitable in work environments where there is possible contact with bodily fluids, microorganisms, and chemicals. They do not contain natural rubber latex and are an excellent alternative for those suffering from Type I allergies. The powder-free gloves offer high flexibility, tactility, tear and chemical resistance. Nitrile gloves can be designed with a special Nitrile formulation so that they feel and fit like latex and allow full range of motion and excellent flexibility to minimize stress and fatigue.
FEATURES OF MEDICAL USE NITRILE GLOVES:
• Ultra Soft to minimize stress.
• 100% Latex Free.
• Powder Free. Non-sterile.
• Stronger. Meets/exceeds NFPA requirements.
• Tested using medical level standard ASTM D6319.
• Blue color.
• 100/box, 10 boxes/case.
• 2 thickness options: 3mil and 4mil, satisfy all situations.
• Length: 9.5" ± 10" Size: S, M, L, XL Available
| Size |
Weight (g) ±0.2 |
Physical Dimension | Physical Property | |||||||||
| Length (mm) |
Palm Width (mm) ±5 |
Finger Thickness (mm) ±0.02 |
Palm Thickness (mm) ±0.02 |
Cuff Thickness (mm) ±0.02 |
Tensile Strength (MPa) |
Elongation (%) |
Test AQL |
Certification | ||||
| Before Aging | After Aging | Before Aging | After Aging | |||||||||
| XS | 3.4 | >235 | 70 | 0.12 | 0.10 | 0.08 | >17 | >16 | >500 | >450 | AQL1.5 | 510K CE ISO9001 ISO13485 |
| S | 3.8 | 80 | ||||||||||
| M | 4.2 | 95 | ||||||||||
| L | 4.6 | 110 | ||||||||||
| XL | 5.0 |
120 |
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NITRILE EXAMINATION GLOVES
SUPERIOR BARRIER PROTECTION AND DEXTERITY
Nitrile Examination Gloves – Powder Free serves to provide protection from unwanted substances or potentially dangerous substances for both the professionals and patients. These gloves are made from high quality 100% nitrile.
(A synthetic co-polymer – Acrylonitrile-Butadiene) are Latex Free and are suitable for NR Latex-Sensitive Medical Professionals (Type 1 allergic reactions). It also has Low Level of Chemical Residue which reduces contact Dermatitis (Type IV Allergic Reaction). The Unique formulation makes the gloves soft and flexible for a comfortable fit. The Micro-Textured surface provides an excellent grip.
Nitrile Examination Gloves – Powder Free meets all international product standards for medical gloves. They also meet all regulatory requirements for Bio-compatibility testing and Latex Protein Allergy.
FEATURES:
- Unique formulation makes the glove soft and flexible for a comfortable fit
- Micro-Textured surface provides non-slip grip when handling instruments
- The dual leached gloves have low chemical residue
- High tensile strength due to its special formulation
- Beaded cuff ensures secured and easy donning
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PRODUCT STANDARD SPECIFICATIONS, PERFORMANCE & CONFORMANCE NITRILE EXAMINATION GLOVE - DISPOSABLE - ITEM CODE: AWTHNG001 |
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Type |
Nitrile Examination Glove- Disposable |
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Material |
Nitrile Butadiene Rubber (NBR) |
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Colour |
Natural White, Off White |
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Design & Feature |
Ambidextrous, Beaded Cuff, Finger Textured |
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Donning Aid |
Chlorinated |
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Product Classification |
MDD: Class I |
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Powder Content |
- |
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Protein Content |
N/A |
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Size Available |
S, M, L, XL |
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Storage Condition |
Product shall be stored under room condition, avoid direct sunlight |
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Shelf Life |
Product shall have shelf life of 3 years from the date of manufacture with the above storage condition |
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Packing Style |
Fully Pack |
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Performance Standard |
ASTM D-6319 EN 455-Part 1, 2 and 3 |
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PHYSICAL DIMENSION - - 3 MILS, 240 MM / 9” |
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Size |
S |
M |
L |
XL |
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Ave width (mm) |
80±10 |
90±10 |
105±10 |
115±10 |
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Ave weight (gm) |
3.4±0.3 |
3.8±0.3 |
4.0±0.3 |
4.3±0.3 |
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Length (mm) |
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Min 240 |
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Thickness |
Cuff |
0.040±0.02 |
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Palm |
0.070±0.02 |
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Finger |
0.080±0.02 |
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PHYSICAL PROPERTIES - ASTM |
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Parameters |
Before Aging |
After Aging |
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Tensile Strength (MPa) |
Elongation at break (%) |
Modulus at 500% (MPa) |
Tensile Strength (MPa) |
Elongation at break (%) |
Modulus at 500% (MPa) |
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Result |
18 - 28 |
650 - 750 |
Max 2.8 |
14 - 18 |
500 - 650 |
Max 2.8 |
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ASTM Requirement |
Min 14 |
Min 650% |
Max 2.8 |
Min 14 |
Min 500% |
N/A |
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PHYSICAL PROPERTIES - EN |
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Parameters |
Before Aging |
After Aging |
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Force at Break (N) |
Elongation at break (%) |
Force at Break (N) |
Elongation at break (%) |
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Result |
9.0 - 11.0 |
N/A |
6.0 - 10.0 |
N/A |
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EN Requirement (median) |
Min 9 N |
N/A |
Min 6 N |
N/A |
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CHEMICAL ANALYSIS |
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Requirement |
Protein Content |
Powder Content |
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Powder Free |
Powder Free |
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Result |
N/A |
Below 2.0 |
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ASTM requirement |
N/A |
Max 2.0 milligram/glove |
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PERFORMANCE |
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Inspection |
Related Defects |
Inspection Level |
AQL |
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Watertight Test |
Holes |
G-1 |
1.5 |
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Visual Inspection |
Major Defects |
2.5 |
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Minor Defects |
4.0 |
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Physical Properties |
Tensile Strength and Elongation |
S-2 |
4.0 |
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Physical Dimension |
Measurement |
S-2 |
4.0 |
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Nitrile Gloves Ingredient:
• Perbunan Nitrile 100.00 phr
• Ammonium caseinate 0.25 phr
• Potassium hydroxide 1.00 phr
• Sulfur 1.00 phr
• Butyl zimate 0.50 phr
• Titanium dioxide 1.00 phr
• Phthylocyanine blue 0.10 phr
• Sodium 2-ethylhexyl sulfate 0.05 phr
• Zinc oxide 0 phr
** Notes: phr = parts per 100 parts of rubber
Physical Characteristic of Nitrile Gloves :-
Tensile strength at break (psi) 2000 to 4000
Elongation (%) 500 to 750
M100, (psi) 200 to 300
Tear resistance, (lb/in) 200 to 500
Abrasion resistance, (gm loss @ 2000 cycles) 0.06 to 0.08
Puncture resistance, (lb./in) 700 to 900
Hexane swell, (%) 5 to 10%
ASTM #2 Oil @ 70, (%) 0
Product Information
Examination gloves grade, Whole Sale Price, Inner packaging, Outer packaging .
Examination Gloves Grade
Grade A Nitrile: Used as Surgical Gloves Sterilized by heat Use in Hospital
Grade B Nitrile: Gloves for general use and general medical examination in hospitals.
Grade C Nitrile: Gloves for use in food industry. Food Grade.
Factory & Machine:
Factory size Machine spec.
Capacity
Manufacturing Process Flow
Quality Standard
Factory Layout is in Green Park area. Capacity 5 Factories around 50 millions boxes per month. Free zone, industrial zone, and north corridor factories.
Factory Location : Thailand (Asia)
Build Size (m) : 80W x 120L x 14H
Area (sqm) : 9,600
Production line Quantity (Line) : 8
Machine Spec.:-
Machine size Width (m) 4
Length (m) 85
Height (m) 15
Speed (Pc/Hour) 20,000
Capacity/Month (Pc) 14,400,000
Lead time/Line (Month) 3
Material prepation system Included
Automatic unloading Included
Manufacturing Process Flow:
NBR latex preparation ผสมวัตถุดิบ → Former cleaning ล้างแม่พิมพ์ → Former temp. conditioning อบแม่พิมพ์ให้แห้ง → Coagulant dipping จุ่มสาร Coagulant → Coagulant drying อบแห้งสาร Coagulant → Latex dipping จุ่มนํ้ายาง → Latex gel and set up (oven) อบหมาดนํ้ายาง → Ring (bead) rolling ม้วนขอบถุงมือ → Leaching ล้างถุงมือ → Latex final cure (oven) อบให้ Nitrile คงตัว → Powder apply (slurry) จุ่มแป้ง → Drying (slurry dry oven) อบแห้งแป้ง → Glove removal ถอดถุงมือ → Drying (oven) อบไล่ความชื้น → Inspection ตรวจสอบ → Sterilize ฆ่าเชื้อ → Packing แพค
Investment & Timeline:
Factory Equipment Material Product R&D ie., Ingredient Test/Qualify Product spec. & Packaging at start of production was around 3 months.
Quality Standard:
Factory & Product Quality Standard:
Verified by ISO 9001 : 2015, ISO 13485, FDA, GMP, PPE (EU) 2016/425, MDD93/42/EEC
Then we started with Mass Production to meet the market requirement.
PRODUCT Tested by: Thailand FDA, PPE (EU) 2016/425, MDD93/42/EEC, FDA USA (510K), SATRA EN374, EN455, CE .
FACTORY Approved with ISO 9001, ISO 13485, Thailand FDA, GMP
