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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 K223375
Device Name Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
Applicant
Kossan International Sdn Bhd3
Wisma Kossan, Lot 782, Jalan Sungai Putus
Off Batu 3 3/4, Jalan Kapar
Klang,  MY 42100
Applicant Contact Cho Sow Fong
Correspondent
Kossan International Sdn Bhd3
Wisma Kossan, Lot 782, Jalan Sungai Putus
Off Batu 3 3/4, Jalan Kapar
Klang,  MY 42100
Correspondent Contact Cho Sow Fong
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received11/04/2022
Decision Date 03/15/2023
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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