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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 K220215
Device Name Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)
Applicant
Ksg Medicare Sdn. Bhd.
Ptd 16063, Kawasan Perindustrian
Tangkak,  MY 84900
Applicant Contact Jennifer Yeo
Correspondent
Truscott Medsci Associates, LLC
180 Burkemeade Ct.
Roswell,  GA  30075
Correspondent Contact Wava Truscott
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received01/26/2022
Decision Date 03/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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