LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR


definition

Device Classification Name

latex patient examination glove

510(k) Number K002314
Device Name LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR
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 07/31/2000
Decision Date 08/17/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No