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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K132354
Device Name POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE
Applicant
Advanced Health Products, Lot 60 & 61
Lorong Senawand 3/2
Senawang Industrial Estate
Seremban, Negeri Sembilan Darul,  MY 70450
Applicant Contact FRANCIS V
Correspondent
Advanced Health Products, Lot 60 & 61
Lorong Senawand 3/2
Senawang Industrial Estate
Seremban, Negeri Sembilan Darul,  MY 70450
Correspondent Contact FRANCIS V
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/29/2013
Decision Date 06/30/2014
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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