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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 K222342
Device Name Betel Gloves Nitrile Examination Glove Powder Free
Applicant
Betel care Sdn. Bhd.
Lot 3342, Jalan Keretapi Lama
7 ½ Miles, Off Jalan Kapar,  MY 42200
Applicant Contact Abdul Rahman Richard Abdullah
Correspondent
Liberty Management Group Limited
75 Executive Drive Suite 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/03/2022
Decision Date 09/24/2022
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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