NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS


Device Classification Name

polymer patient examination glove

510(k) Number K021220
Device Name NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Original Applicant
SIAM SEMPERMED CORP. LTD.
30798 us hwy 19 north
palm harbor, 
FL 
34684

Original Contact john v calhoun
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 03/22/2002
Decision Date 06/06/2002
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