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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 K221887
Device Name Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color
Applicant
Guangdong Kingfa Sci. & Tech. Co., Ltd.
No. 28 Delong Ave., Shijiao Town, Qingcheng District
Qingyuan,  CN 511545
Applicant Contact Xiaoge Yu
Correspondent
Guangdong Kingfa Sci. & Tech. Co., Ltd.
No. 28 Delong Ave., Shijiao Town, Qingcheng District
Qingyuan,  CN 511545
Correspondent Contact Xiaoge Yu
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/29/2022
Decision Date 09/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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