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U.S. Department of Health and Human Services

510(K) Premarket Notification
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sterile polyisoprene powder free surgical glove, tested for use with chemotherapy drugs Grand Work Plastic Products Co., Ltd k230217 05/13/2023
powder free nitrile examination gloves (black), tested for use with chemotherapy drugs and fentanyl citrate Shanxi Hongjin Plastic Technology Co., Ltd. k230779 06/09/2023
biodegradable nitrile powder free examination gloves tested for use with chemotherapy drugs, fentanyl citrate and select other drugs (blue) Better Care Plastic Technology Co., Ltd. k231567 10/04/2023
biodegradable nitrile powder free examination gloves tested for use with chemotherapy drugs and fentanyl citrate (blue) Syntex Healthcare Products Co., Ltd. k231643 09/08/2023
powder free nitrile examination gloves, orange Shanxi Hongjin Plastic Technology Co., Ltd. k220229 03/26/2022
vinyl co-polymer powder-free examination gloves, black Grand Work Plastic Products Co., Ltd k220240 03/31/2022
sterile nitrile powder free examination gloves tested for use with chemotherapy drugs and fentanyl citrate (blue) Grand Work Plastic Products Co., Ltd k220249 05/26/2022
sterile powder free nitrile examination gloves (blue), tested for use with chemotherapy drugs Grand Work Plastic Products Co., Ltd k220250 05/11/2022
powder free nitrile examination gloves (blue),tested for use with chemotherapy drugs and fentanyl citrate Better Care Plastic Technology Co., Ltd. k221269 07/27/2022
nitrile powder free examination gloves, tested for use with chemotherapy drugs and fentanyl citrate (dark blue) Better Care Plastic Technology Co., Ltd. k222449 08/27/2022

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