‘Surgicare’ Sterile Latex Powdered 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 EN 556 and ISO 13485 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 F1671.976)
  • AQL 1.5 for pin holes


Product Characteristics
  • Made from natural rubber latex
  • Anatomically shaped
  • Textured surface for excellent instrument grip
  • Prepowdered 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
  • BS 4005
  • CE certified
  • Licensee of Bureau of Indian Standards, IS 13422 and IS 4148


Standards
  • Conforms to Standards ASTM D 3578, EN 455 Part I &II
  • Manufactured in ISO 9001:2000 Certified Facility


Quality Control
  • Factory Standard of AQL 1.5 (ASTM Standard AQL 4.0)
  • Uncompromised inspection of every glove



PHYSICAL DIMENSIONS

Length(mm) Min

Size

5.5

6.0

6.5

7.0

7.5

8.0

8.5

9.0

Length

250

 

280

 

Width(mm)

Size

5.5

6.0

6.5

7.0

7.5

8.0

8.5

9.0

Width

72±4

77±5

83±5

89±5

95±5

102±6

108±6

114±6

Thickness(mm) Min

Cuff

 

 

 

0.13

 

 

Palm

 

 

 

0.16

 

 

Finger

 

 

 

0.16

 

 


Characteristics

Before Ageing

After Ageing
(100 ± 2° C for 22 ± 0.3 hrs /
70± 2°C for166 ± 2 hrs)

Tensile Strength (Mpa) min.

24

18

Ultimate Elongation (%) min.

750

560

Stress at 500% Elongation (Mpa) Max.

5.5

NA

Force at break (N) Min.

9

9


PHYSICAL PROPERTIES

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 - < 100 mg/dm2
Powder amount - < 15 mg/ dm2
Sterilization - Ethylene Oxide / Gamma as per customer requirement
Sterility( for sterile product) - Shall pass the ster ility test
Packaging - 1 pair of gloves in a paper wallet and on e wallet per pouch. 50 pouches per Inner box and 8 Inner Box per Master carton / as per customer requirements.
Labelling - Shall comply with the corresponding label ing specification and customer requirements
Shelf life - 5 years from the Date of manufacture
Storage condition - Gloves shall be stored in cool dr y place and away from direct light and ozone.
Certificates - ISO 9001:2008 , ISO 13485 :2003 & ISO 14001 : 2004
Quality Standards - ASTM D 3577, EN 455 & ISO 10282


» Product Specification of Powdered Latex Surgical Gloves