NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE


Device Classification Name

polymer patient examination glove

510(k) Number K992177
Device Name NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE
Applicant
PT. BERLIAN GLOVINDO
jln. raya medan rantau prapat
km +230 desa damuli
kec. labuhan batu – n. sumatra, 

ID

Applicant Contact tony jap
Correspondent
PT. BERLIAN GLOVINDO
jln. raya medan rantau prapat
km +230 desa damuli
kec. labuhan batu – n. sumatra, 

ID

Correspodent Contact tony jap
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 06/28/1999
Decision Date 07/29/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No