‘Surgicare Low Pro’ Sterile Latex Powdered Surgical Gloves with protein content less than 100µg/dm2
  • Latex protein content less than 100µg/dm2 to reduce risk of user being sensitized to Latex Protein Allergy Type I. On special request Protein Content less than 50µg/dm2 can be provided.
  • Non-detectable levels of chemical residue reduce allergic skin reactions Like Contact Dermatitis – Type IV Allergy.
  • Lightly powdered with Modified Bio-Absorbable Corn starch USP Grade, To prevent wound infections and granulomas.
  • Manufactured in clean environment to achieve bio burden level of less than 20 cfu Prior to Sterilization.
  • 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
  • Passes Bio-Compatibility test as per ISO 10993-10


Standards
  • ASTM D-3577 & EN 455 Part I, II & III
  • Conforms to Standards of BIS - IS 13422
  • Registered with US FDA (510K)


Quality Control
  • 100% Inspected
  • Passes Viral Penetration Test
  • Factory Standard of AQL 0.65



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 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 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 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 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 Latex Powdered Surgical Gloves with Protein content less than 100µg/dm2