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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K190241
Device Name Sterile Latex Surgical Glove, Powder Free
Applicant
Careglove Global Sdn. Bhd.
Lot 17479, Lrg Senawang 3/2, Off Jln Senawang 3, Senawang In
Seremban,  MY 70450
Applicant Contact Lim Kwee Shyan
Correspondent
Careglove Global Sdn. Bhd.
Lot 17479, Lrg Senawang 3/2, Off Jln Senawang 3, Senawang In
Seremban,  MY 70450
Correspondent Contact Lim Kwee Shyan
Regulation Number878.4460
Classification Product Code
KGO  
Date Received02/06/2019
Decision Date 12/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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