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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 K220561
Device Name Disposable Medical Nitrile Examination Gloves
Applicant
Nanjing Universal Medical Equipment Co., Ltd.
288 Qinhuai Ave., Yongyang St., Lishui District
Nanjing,  CN 210000
Applicant Contact Jerry Gao
Correspondent
Nanjing Universal Medical Equipment Co., Ltd.
288 Qinhuai Ave., Yongyang St., Lishui District
Nanjing,  CN 210000
Correspondent Contact Jerry Gao
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/28/2022
Decision Date 04/14/2022
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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