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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 K223221
Device Name Non-Sterile Powder Free Nitrile Examination Gloves
Applicant
Dynacare Sdn Bhd
Lot 15528 (Pt 5001), Kawasan Perusahaan Kampung Acheh
Sitiawan,  MY 32000
Applicant Contact Chow Choong Keong
Correspondent
Novo Quality Services Sdn Bhd
Unit No 625 & 627, Block A, Kelana Centre Pt. 3
Jalan Ss7/19, Kelana Jaya
Petaling Jaya,  MY 47301
Correspondent Contact Nancy Nga
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received10/17/2022
Decision Date 01/13/2023
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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