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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 K925358
Device Name DERMATOUCH PLUS HYPOALLERGENIC EXAMINATION GLOVES
Applicant
Colonial Surgical Supply, Inc.
C/O Regulatory/Technical Assoc
73 Franklin Tpk.
Allendale,  NJ  07401
Applicant Contact ROBERT J STAAB
Correspondent
Colonial Surgical Supply, Inc.
C/O Regulatory/Technical Assoc
73 Franklin Tpk.
Allendale,  NJ  07401
Correspondent Contact ROBERT J STAAB
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/22/1992
Decision Date 04/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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