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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 K153744
Device Name A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)
Applicant
A1 GLOVE SDN BHD
LOT 3726, KAWASAN PERINDUSTRIAN NILAI,
MUKIM SETUL
NILAI,  MY 71900
Applicant Contact CONNIE YUNG
Correspondent
A1 GLOVE SDN BHD
LOT 3726, KAWASAN PERINDUSTRIAN NILAI,
MUKIM SETUL
NILAI,  MY 71900
Correspondent Contact John Phan
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/28/2015
Decision Date 08/04/2016
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
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