LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)


Device Classification Name

surgeon’s gloves

510(k) Number K991950
Device Name LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)
Applicant
LAGLOVE (M) SDN. BHD.
jalan simpang balak, off batu
13, jalan cheras, 43000 kajang
selangor darul ehsan mala, 

MG
Applicant Contact g. baskaran
Correspondent
LAGLOVE (M) SDN. BHD.
jalan simpang balak, off batu
13, jalan cheras, 43000 kajang
selangor darul ehsan mala, 

MG
Correspodent Contact g. baskaran
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 06/09/1999
Decision Date 08/12/1999
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