MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM…


Device Classification Name

surgeon’s gloves

510(k) Number K111807
Device Name MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM…
Applicant
MEDLINE INDUSTRIES, INC.
one medline place
mundelein, 
IL 
60060

Applicant Contact matt clausen
Correspondent
MEDLINE INDUSTRIES, INC.
one medline place
mundelein, 
IL 
60060

Correspodent Contact matt clausen
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 06/27/2011
Decision Date 08/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No