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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 K925856
Device Name SAFEHEALTH BRAND LATEX HYPOALLERGENIC EXAM GLOVES
Applicant
Motrend International Corp.
73 Franklin Tpk
Allendale,  NJ  07401
Applicant Contact ROBERT J STAAB
Correspondent
Motrend International Corp.
73 Franklin Tpk
Allendale,  NJ  07401
Correspondent Contact ROBERT J STAAB
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/17/1992
Decision Date 06/01/1993
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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