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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 K220859
Device Name Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)
Applicant
Careglove Global Sdn. Bhd.
Lot 17479, Lorong Senawang 2/3, Off Jalan Senawang 3,
Senewang Industrial Estate
Seremban,  MY 70450
Applicant Contact Lim Kwee Shyan
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  
Date Received03/24/2022
Decision Date 09/09/2022
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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