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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 K262208
Device Name Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid – Blue;Non-sterile, Powder Free Nitrile Examination Gloves - Pink
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   QDO  
Date Received06/30/2026
Decision Date 10/01/2026
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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