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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 K922903
Device Name HYGIENEX EXAMINATION GLOVES
Applicant
Hygienex Corp.
2263 Pasong Tamo Ext.
Makati, Metro Manila,  PH
Applicant Contact MARTIN P LORENZO
Correspondent
Hygienex Corp.
2263 Pasong Tamo Ext.
Makati, Metro Manila,  PH
Correspondent Contact MARTIN P LORENZO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/16/1992
Decision Date 02/18/1993
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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