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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 K011412
Device Name POWDER-FREE VINYL EXAM GLOVES
Applicant
Heyuan Hongli Industries, Inc.
198 Ave. De La D'Emerald
Sparks,  NV  89434 -9550
Applicant Contact JANNA P TUCKER
Correspondent
Heyuan Hongli Industries, Inc.
198 Ave. De La D'Emerald
Sparks,  NV  89434 -9550
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received05/08/2001
Decision Date 05/31/2001
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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