SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM


Device Classification Name

patient examination glove, specialty

510(k) Number K992162
Device Name SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM
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
LZC  
Date Received 06/25/1999
Decision Date 08/30/1999
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