Catalogue values for Single use Rubber Examination Gloves (V2)

Category Specification Bid Requirement (Allowed Values)
GENERAL Product Description Single Use Medical Examination Gloves
Sterility Non-Sterile
STANDARD Conformity to Indian Standard IS 15354 Part 1 (Latest)
PRODUCT INFORMATION Type as per IS 15354 Part 1 Type 1
Material of Gloves Natural Rubber Latex
Surface Finish Textured surface over the finger tip
Powder Powdered
Size of Gloves 9 (Extra Large)
All dimensions & tolerances of the glove shall be as per IS-15354 (Part 1) Yes
Maximum and minimum thickness of the gloves shall be as per IS-15354(Part 1) Yes
PACKAGING & MARKING Packaging & marking shall be as per IS-15354 (Part 1) Yes
Pack Type Box of 100 Non-Sterile Goves
CERTIFICATIONS & REPORTS Compliance to Medical Device Rule (MDR) 2017 as amended till date Yes
Availability of valid medical device license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date Yes
Manufacturing unit certification ISO:13485 (Latest)
Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date Yes
Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission and/or along with supplies as per buyer requirement Yes
SHELF LIFE Shelf Life from the date of manufacture (in months) 36, 48, 60 Or higher
ADVANCE SAMPLE Agree to provide advance sample of the product for buyer's approval after award of contract and before commencement of supply in case of bidding only No