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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 K944510
Device Name VINYL EXAMINATION GLOVE, POWDER-FREE
Applicant
American Gemini, Inc.
999 Anita Ave.
Antioch,  IL  60002
Applicant Contact PAUL HEAVNER
Correspondent
American Gemini, Inc.
999 Anita Ave.
Antioch,  IL  60002
Correspondent Contact PAUL HEAVNER
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/15/1994
Decision Date 10/18/1994
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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