LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)


Device Classification Name

surgeon’s gloves

510(k) Number K992019
Device Name LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
LAGLOVE (M) SDN. BHD.
lot 478, jalan simpang balak,
off batu 13, jalan cheras
kajang, selangor, darul ehsan, 

MY

43000

Applicant Contact g. baskaran
Correspondent
LAGLOVE (M) SDN. BHD.
lot 478, jalan simpang balak,
off batu 13, jalan cheras
kajang, selangor, darul ehsan, 

MY

43000

Correspodent Contact g. baskaran
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 06/16/1999
Decision Date 08/05/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No