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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 K250578
Device Name Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
Applicant
Careglove Global Sdn. Bhd.
Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3,
Senawang Indsutrial Estate
Seremban,  MY 70450
Applicant Contact Lim Kwee Shyan
Correspondent
Careglove Global Sdn. Bhd.
Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3,
Senawang Indsutrial Estate
Seremban,  MY 70450
Correspondent Contact Lim Kwee Shyan
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received02/27/2025
Decision Date 04/01/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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