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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 K953709
Device Name DERRICK SAFETOUCH
Applicant
M.P.S. Pharm'L Int'L
7542 N. Oakley
Chicago,  IL  60645
Applicant Contact MAYNARD SANCHEZ
Correspondent
M.P.S. Pharm'L Int'L
7542 N. Oakley
Chicago,  IL  60645
Correspondent Contact MAYNARD SANCHEZ
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/09/1995
Decision Date 11/06/1995
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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