NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED)


Device Classification Name

polymer patient examination glove

510(k) Number K030075
Device Name NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED)
Original Applicant
BEST MANUFACTURING COMPANY-DISTRIBUTION CENTER
579 edison st.
menlo, 
GA 
30731

Original Contact david c young
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 01/08/2003
Decision Date 03/05/2003
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