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Shen Wei (Usa), Inc.

FDA 510(k) & PMA Approved Dispositivos — 19 products

Total de dispositivos19
Categorías0
Última decisión de la FDA
TipoNúmeroNombre del dispositivoCódigoFechaAcciones
510(k) K213141 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 SolutionLZA2022-05-28 Ver
510(k) K213142 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 SolutionLZA2022-01-28 Ver
510(k) K213144 Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White ColorsLYZ2021-12-22 Ver
510(k) K211620 Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)LYY2021-08-19 Ver
510(k) K211455 Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White ColorsLZA2021-07-28 Ver
510(k) K202085 Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, GreenLZA2021-06-21 Ver
510(k) K202083 Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy DrugsLZA2021-03-25 Ver
510(k) K202080 Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black ColorLZA2021-03-24 Ver
510(k) K202081 Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, BlueLZA2021-03-19 Ver
510(k) K202082 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 AcidLZA2021-03-17 Ver
510(k) K202086 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 ColorsLZA2021-03-16 Ver
510(k) K202078 Biodegradable Thermoplastic Elastomer Examination (TPE) GloveLZA2021-03-05 Ver
510(k) K202076 Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray ColorsLZA2021-03-05 Ver
510(k) K190466 PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl CitrateLZA2019-09-26 Ver
510(k) K173766 PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo DrugsLZC2018-07-08 Ver
510(k) K172678 THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVELZA2017-11-24 Ver
510(k) K162312 Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green ColorLZA2017-07-25 Ver
510(k) K170290 Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo drLZA2017-05-24 Ver
510(k) K161074 Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorLZA2016-11-17 Ver
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