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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K951007
Device Name MORE CHAIN POWDER FREE VINYL EXAMINATION GLOVES
Applicant
Allerderm Laboratories, Inc.
P.O. Box 931
Mill Valley,  CA  94941
Applicant Contact BENJAMIN K LEE
Correspondent
Allerderm Laboratories, Inc.
P.O. Box 931
Mill Valley,  CA  94941
Correspondent Contact BENJAMIN K LEE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received02/28/1995
Decision Date 07/26/1995
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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