SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES


Device Classification Name

polymer patient examination glove

510(k) Number K992210
Device Name SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES
Applicant
SAFESKIN CORP.
12671 high bluff dr.
san diego, 
CA 
92130

Applicant Contact eugene v goorchenko
Correspondent
SAFESKIN CORP.
12671 high bluff dr.
san diego, 
CA 
92130

Correspodent Contact eugene v goorchenko
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 07/01/1999
Decision Date 09/10/1999
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