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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 K973615
Device Name SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX EXAMINATION GLOVES
Applicant
Macro Rubber Industrial, Inc.
3234 Ella Ln.
New Port Riche,  FL  34655
Applicant Contact ED RANSOM
Correspondent
Macro Rubber Industrial, Inc.
3234 Ella Ln.
New Port Riche,  FL  34655
Correspondent Contact ED RANSOM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/23/1997
Decision Date 05/20/1998
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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