NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS)


Device Classification Name

latex patient examination glove

510(k) Number K111133
Device Name NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS)
Applicant
SSC SURAT THANI
13900 49th street north
clearwater, 
FL 
33762

Applicant Contact william e harris , iii
Correspondent
SSC SURAT THANI
13900 49th street north
clearwater, 
FL 
33762

Correspodent Contact william e harris , iii
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 04/22/2011
Decision Date 06/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No