SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE)


Device Classification Name

vinyl patient examination glove

510(k) Number K991951
Device Name SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE)
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
LYZ  
Date Received 06/10/1999
Decision Date 07/26/1999
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