Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs

Polymer Patient Examination Glove

Guang Dong Kingfa Sci. & Tech.Co., Ltd.

The following data is part of a premarket notification filed by Guang Dong Kingfa Sci. & Tech.co., Ltd. with the FDA for Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK213040
510k NumberK213040
Device Name:Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs
ClassificationPolymer Patient Examination Glove
Applicant Guang Dong Kingfa Sci. & Tech.Co., Ltd. No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan,  CN 511545
ContactXiaoge Yu
CorrespondentXiaoge Yu
Guang Dong Kingfa Sci. & Tech.Co., Ltd. No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan,  CN 511545
Product CodeLZA  
Subsequent Product CodeLZC
Subsequent Product CodeOPJ
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-22
Decision Date2022-04-27

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