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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 K220644
Device Name Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs
Applicant
YTY Industry (Manjung) Sdn Bhd
Lot 1422-1424, Batu 10 Lekir
Sitiawan,  MY 32020
Applicant Contact Punitha Samy
Correspondent
YTY Industry (Manjung) Sdn Bhd
Lot 1422-1424, Batu 10 Lekir
Sitiawan,  MY 32020
Correspondent Contact Punitha Samy
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ  
Date Received03/04/2022
Decision Date 03/25/2023
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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