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Shen Wei USA, Inc. FDA Approvals

0 new drug approvals and 13 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution510(k)May 28, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	May 28, 2022
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution510(k)Jan 28, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jan 28, 2022
Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors510(k)Dec 22, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Dec 22, 2021
Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)510(k)Aug 19, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Aug 19, 2021
Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors510(k)Jul 28, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jul 28, 2021
Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green510(k)Jun 21, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jun 21, 2021
Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs510(k)Mar 25, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 25, 2021
Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color510(k)Mar 24, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 24, 2021
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue510(k)Mar 19, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 19, 2021
Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid510(k)Mar 17, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 17, 2021
Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors510(k)Mar 16, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 16, 2021
Biodegradable Thermoplastic Elastomer Examination (TPE) Glove510(k)Mar 5, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 5, 2021
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors510(k)Mar 5, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 5, 2021

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