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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 K211666
Device Name Powder Free Nitrile Examination Gloves, Blue Chemotest
Applicant
Careglove Global SDN. BHD.
Lot 17479, Lorong Senawang 2/3, Off Jalan Senawang 3,
Senawang Industrial Estate
Seremban,  MY 70450
Applicant Contact Siti Khatijah Ahmad
Correspondent
Careglove Global SDN BHD
Lot 17479, Lorong Senawang 2/3, Off Jalan Senawang 3,
Senewang Industrial Estate
Seremban,  MY 70450
Correspondent Contact Siti Khatijah Ahmad
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received06/01/2021
Decision Date 01/09/2022
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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