N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE


Device Classification Name

polymer patient examination glove

510(k) Number K992170
Device Name N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
Applicant
BEST MANUFACTURING COMPANY
579 edison st.
menlo, 
GA 
30731

Applicant Contact david c young
Correspondent
BEST MANUFACTURING COMPANY
579 edison st.
menlo, 
GA 
30731

Correspodent Contact david c young
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 06/28/1999
Decision Date 09/07/1999
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