SERJUN PRE-POWDERED STERILE LATEX SURGICAL GLOVES
- Non-detectable levels of chemical residue reduces allergic skin reactions like Contact Dermatitis - Type IV Allergy
- Lightly powdered with Modified Bio-Absorbable Corn starch USP Grade (No talc), to prevent wound infections and granulomas
- Manufactured in clean environment to comply with ISO 13485:2016 requirements
- Sterilized in a validated process cycle to achieve sterility assurance level of 106, and air wash cycles to reduce sterilant residue to less than 5 ppm
- Latex Film structure passes Viral Penetration Test (ASTM F1671:2007)
- AQL 1.5 for pin holes
PRODUCT CHARACTERISTICS
- Made from natural rubber latex
- Anatomically shaped
- Textured surface for excellent instrument grip
- Pre-powdered with USP Bio-absorbable cornstarch. (FDA Approved)
- Beaded cuff with minimum length of 280 mm. (for extra protection)
- Meets International standards ASTM D 3577, EN 455 part I, II & III
- Licensee of Bureau of Indian Standards IS 13422:1992
STANDARDS
- Conforms to Standards ASTM D 3577, EN 455 Part I &II
- Manufactured in ISO 9001:2008 Certified Facility
QUALITY CONTROL
- In-House Standard of AQL 1.5 (ASTM Standard AQL 4.0)
- Uncompromised inspection of every glove
PHYSICAL DIMENSIONS
|
Size |
Length (mm) Min |
Palm Width (mm) Min |
Thickness (mm) |
||
|
Cuff |
Palm |
Finger |
|||
|
5½ |
250 |
72 ± 5 |
0.12 |
0.16 |
0.18 |
|
6 |
265 |
76 ± 6 |
|||
|
6½ |
83 ± 6 |
||||
|
7 |
89 ± 6 |
||||
|
7½ |
95 ± 6 |
||||
|
8 |
102 ± 6 |
||||
|
8½ |
108 ± 6 |
||||
|
9 |
114 ± 6 |
||||
PHYSICAL PROPERTIES
|
Characteristics |
Before Ageing |
After Ageing (100°C for 22 hrs.) |
|
Tensile Strength (Mpa) min. |
24 |
18 |
|
Ultimate Elongation (%) min. |
750 |
560 |
|
Stress at 500% Elongation (Mpa) Max. |
5.5 |
---- |
|
Force at Break (N), Min |
9 |
9 |
PRODUCT INFORMATION
|
Freedom from Holes |
Inspection level G1, AQL : 1.5 |
|
Visual defects - Major |
Inspection level G1, AQL : 1.5 |
|
Visual defects – Minor |
Inspection level G1, AQL : 2.5 |
|
Total protein content |
< 150 µg /dm2 |
|
Powder amount |
< 15 mg/ dm2 |
|
Sterilization |
Ethylene Oxide / Gamma as per customer requirement |
|
Sterility( for sterile product) |
Shall pass the sterility test |
|
Packaging |
1 pair of gloves in a paper wallet and on a wallet per pouch. 25 pouches per Inner box and 20 Inner Box per Master carton / as per customer requirements. |
|
Labelling |
Shall comply with the corresponding labeling specification and customer requirements |
|
Shelf life |
5 years from the Date of manufacture |
|
Storage condition |
Gloves shall be stored in cool dry place and away from direct sun light. |
|
Certificates |
ISO 9001:2008 , ISO 13485 :2016 & ISO 14001 : 2004 |
|
Quality Standards |
ASTM D 3577, EN 455 & IS 13422:1992. |
PACKAGING
|
Material |
Quantity |
Dimension |
|
Paper Wallet (Folded) |
One Pair |
19(L) x 10(W) |
|
Pouch |
One Pair |
24(L) x 14(W) |
|
Inner Box |
25 Pairs |
26(L) x 10(W) x 10(H) |
|
Master Carton |
500 Pairs |
53(L) x 29(W) x 52(H) |