POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG


Device Classification Name

polymer patient examination glove

510(k) Number K111589
Device Name POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG
Applicant
DERMA CARE PLUS PRODUCTS, LLC
2614 main street
green bay, 
WI 
54311

Applicant Contact joseph neuser
Correspondent
DERMA CARE PLUS PRODUCTS, LLC
2614 main street
green bay, 
WI 
54311

Correspodent Contact joseph neuser
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 06/07/2011
Decision Date 08/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No