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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 K992122
Device Name TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE
Applicant
Maxxim Medical
477 Commerce Blvd.
Oldsmar,  FL  34677
Applicant Contact JOYCE MOODY
Correspondent
Maxxim Medical
477 Commerce Blvd.
Oldsmar,  FL  34677
Correspondent Contact JOYCE MOODY
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received06/23/1999
Decision Date 07/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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