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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
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