‘Surgicare Low Pro’ Sterile Latex Powdered Surgical Gloves with protein content less than 100µg/dm2
Surgicare Low Progloves is made from NaturalRubber Latex. The protein content is less than 100 dm2 to reduce risk of user being sensitized to Latex Protein Allergy Type 1.The glove is anatomically shaped with thumb ball effect,reducing hand fatigue during surgicalprocedures.The precision design fit and micro rough surface provides optimum comfort and better instrument grip without compromising on sensitivity.Surgicare Low Pro gloves provides excellent barrier protection for both doctor and patient.

SAFETY FEATURES
  • Sterilized in a validated process cycle to achieve sterility assurance levelof 101and air wash cycles to reduce sterilant residue to less than 4mg/unit.
  • Chemicalresidue almost nil,eliminates risk of Contact Dermatitis- Type IV Allergy.
  • Lightly powdered with Modified Bio-Absorbable Corn starch to prevent woundinfections and granulomas
  • ManufacturedIn a clean environment to achieve low blo burden level prior to sterilization.This achieves low Pyrogen levelafter sterilization.
  • Manufactured in a clean environment to comply with EN556 & ISO 13485 requirements
Standards
  • ASTM :[)..3577-2009 & EN 455-1:2000,EN 455-2:2015 & EN455-3:2015,ISO 10282:2014 & IS 13422.
  • Registered with us FDA (510K).
  • Passes BI Compatibilty Test as per ISO 10993-10.
  • CE Mark- MOD Class lla / PPE Cat.Ill.


Quality Control
  • 100% Inspected
  • Passes viral penetration test-ASTM F1671:2007.
  • Factory Standard 0.6SAQL for Pinholes.



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