Product Name:Sterile Latex Surgical Gloves
Size: 6.5, 7, 7.5, 8, 8.5,
Varieties:Powdered and Powder-Free，Textured Surface。
Manufacturer Name:Shandong Yuyuan Latex Gloves Co., Ltd
Manufacturer Manufacturing Address:Industrial Zone, Linqing City, 252600 Shandong Province, China
Contact Detail:Industrial Zone, Linqing City, Shandong Province, China. Postal Code:252600
Product Standard:Product compliance to ISO10282:2002 standard
Product Properties and Composition:This product is made from natural latex, thru the procedure sequence of
Preparation Latex Compound, Coagulant Dipping, Latex Dipping, Pre-Leaching, Drying and Curing, Post-Leaching,
Wet Powdering, Gloves Stripping, and Offline Dry and Cure Tumbling. All materials were harmless and safe for use in
medical device, provide excellent flexibility and tear resistant. Rolled cuff for donning easily. Do not contain stimulating
materials; it can be decomposed naturally after using
Scope:Applicable to the surgical operation to protect patients and users, and to avoid cross-infection.
Attention
1. This product adopts ethylene oxide gas to sterile.
2. Use forbidden if the package is broken.
3. Adopt appropriate glove to avoid broken and fall.
4. Avoid contact to oil, acid, copper, manganese and other materials that harm rubber latex;
5. Avoid exposure to sunlight, UV light and excess ozone environment;
6. Do not use this product if users allergy to natural latex;
7. Remove excessive residual powder under sterile environment, if necessary.
User Guideline
1. This product is non-ambidextrous, selection of correct size gloves and right hand is important;
2. Remove rings and other jewelry, and trim fingernails before donning the gloves,;
3. This product is single use, dispose the product according to medical disposal procedure preventing environmental
contamination.
Storage:Should be stored in well-ventilated, cool dry storage (room temperature below 30 Celsius-degrees, relative
humidity below 80 percent ) and store on the shelves 200 mm above the ground
Specification
1. Product : Sterile Powder-free Latex Surgical Gloves
2. Material :Natural Rubber Latex 3、Type :Sterile By ETO Gas
4. Glove design & Feature :Anatomic shape, Textured Surface over part of the glove；Polymer coated 5、Cuff : Bended
6. Usage : For single use only 7、Color :Ivory
8. Packaging :2 pieces/ inner pouch,50 pouches / box,10boxes / carton. 9、Dimensions (Available in 7 sizes) :
| SIZE | GLOVE WEIGHT(g/piece) | Palm Width (mm) | Length (mm) | ||
| ISO 10282 | YUYUAN | ISO 10282 | YUYUAN | ||
| 6 | 7.0±0.5 | 77±5 | 79±3 | Min.260 | Min.260 |
| 6.5 | 7.5±0.5 | 83±5 | 85±3 | Min.260 | Min.260 |
| 7 | 8.0±0.5 | 89±5 | 89±3 | Min.270 | Min.270 |
| 7.5 | 8.5±0.5 | 95±5 | 95±3 | Min.270 | Min.270 |
| 8 | 9.5±0.5 | 102±6 | 105±3 | Min.270 | Min.270 |
| 8.5 | 10.5±0.5 | 108±6 | 111±3 | Min.280 | Min.280 |
| 9 | 11±0.5 | 114±6 | 114±3 | Min.280 | Min.280 |
Thickness:
| Location of Thickness Measurement | Single wall (mm)smooth area | |
| ISO 10282 | YUYUAN | |
| Finger | Min.0.10 | Min.0.16 |
| Palm | Min.0.10 | Min.0.13 |
| Cuff | Min.0.10 | Min.0.10 |
Physical Properties:
| Before Aging | After Aging | |||
| ISO 10282 | YUYUAN | ISO 10282 | YUYUAN | |
| Force at break (N) | Min.12.5 | Min.12.5 | Min.9.5 | Min.9.5 |
| Elongation (%) | Min.700 | Min.700 | Min.550 | Min.550 |
12.（Aqueous soluble) Protein Content :Max.200μg/dm2 13、Powder Level :Max.2mg/per piece for powder free
14. Compliance Standards :ISO 10282
15.
| Inspection Criteria: | Inspection Level | AQL | |
| (Sampling & Inspection: ISO 2859-1) | Watertight Test | G1 | 1.5 |
| Major Defects | G1 | 2.5 | |
| Minor Defects | G1 | 4.0 | |
| Dimensions | S2 | 4.0 | |
| Physical Properties | S2 | 4.0 |
16. Quality Assurance :ISO 13485 certified by TUV
