NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)


Device Classification Name

polymer patient examination glove

510(k) Number K103670
Device Name NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)
Applicant
INNOVATIVE GLOVES CO; LTD
800 moo 4,saambin-ban klang
rd kuanlang
hatyai, songkhla, 

TH

90110

Applicant Contact rajeev sood
Correspondent
INNOVATIVE GLOVES CO; LTD
800 moo 4,saambin-ban klang
rd kuanlang
hatyai, songkhla, 

TH

90110

Correspodent Contact rajeev sood
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 12/16/2010
Decision Date 03/31/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No