POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E


Device Classification Name

latex patient examination glove

510(k) Number K022701
Device Name POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E
Original Applicant
PERUSAHAAN GETAH ASAS SDN BHD
lot 754, jalan haji sirat
selangor, 

MY

41720

Original Contact tan kong chang
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 08/14/2002
Decision Date 09/17/2002
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