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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 K913888
Device Name MED-SAFE(TM) LATEX EXAMINATION GLOVES
Applicant
Promed Corp.
14134 Nephron Ln.
Hudson,  FL  34667
Applicant Contact ACHARYA
Correspondent
Promed Corp.
14134 Nephron Ln.
Hudson,  FL  34667
Correspondent Contact ACHARYA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/29/1991
Decision Date 02/07/1992
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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