NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS)


codes

Device Classification Name

polymer patient examination glove

510(k) Number K002391
Device Name NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS)
Original Applicant
SIAM SEMPERMED CORP. LTD.
30798 us hwy 19 north
palm harbor, 
FL 
34684

Original Contact william harris
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 08/04/2000
Decision Date 12/04/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No