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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
Predetermined Change
Control Plan Authorized		 No
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