PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES

Device Classification Name

vinyl patient examination glove

510(k) Number K992205
Device Name PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
Applicant
SHANGHAI CHINASTAR CORP.
55 northern blvd.
suite 200
great neck, 
NY 
11021

Applicant Contact susan d goldstein-falk
Correspondent
SHANGHAI CHINASTAR CORP.
55 northern blvd.
suite 200
great neck, 
NY 
11021

Correspodent Contact susan d goldstein-falk
Regulation Number 880.6250
Classification Product Code
LYZ  
Date Received 06/30/1999
Decision Date 07/23/1999
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