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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K070760
Device Name POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE
Applicant
Derma Care Plus Products, LLC
1500 River Pines Dr.
Green Bay,  WI  54311
Applicant Contact JOSEPH NEUSER
Correspondent
Derma Care Plus Products, LLC
1500 River Pines Dr.
Green Bay,  WI  54311
Correspondent Contact JOSEPH NEUSER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/20/2007
Decision Date 06/07/2007
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
Predetermined Change
Control Plan Authorized		 No
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