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U.S. Department of Health and Human Services

510(K) Premarket Notification
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vinyl co-polymer powder free examination gloves GRAND WORK PLASTIC PRODUCTS CO., LTD. k142409 12/05/2014
powder free vinyl patient examination gloves ( yellow, white, blue, pink ) EVER LIGHT PLASTIC PRODUCTS CO., LTD. k142570 12/18/2014
powder free vinyl patient examination gloves EVER LIGHT PLASTIC PRODUCTS CO., LTD. k142571 12/17/2014
powder free vinyl patient examination gloves (green) Supermax Plastic Products Co., Ltd k152692 12/21/2015
sterile polyisoprene powder free surgical gloves Better Care Plastic Technology Co.,Ltd. k171047 06/22/2017
sterile polyisoprene powder free surgical gloves, tested for use with chemotherapy drugs Better Care Plastic Technology Co., Ltd k171898 08/18/2017
powder free vinyl patient examination gloves (yellow, white) Shanxi Hongjin Plastic Technology Co., Ltd k180260 06/12/2018
powder free vinyl patient examination gloves Shanxi Hongjin Plastic Technology Co., Ltd k180381 11/07/2018
powder free nitrile examination glove, tested for use with chemotherapy drugs (blue) Better Care Plastic Technology Co., Ltd k182600 11/30/2018
powder free vinyl patient examination gloves Shijiazhuang Hongjun Plastic Manufacture Co., Ltd. k211177 07/17/2021
powder free nitrile examination gloves (blue), tested for use with chemotherapy drugs Shanxi Hongjin Plastic Technology Co., Ltd. k211604 10/27/2021
powder free nitrile examination gloves (blue, purple-blue), tested for use with chemotherapy drugs Luliang Hongruida Health Protection Technology Co., Ltd. k213440 02/18/2022
nitrile vinyl blend powder free examination gloves (black) Grand Work Plastic Products Co., Ltd k213574 07/12/2022
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
powder free polyurethane examination gloves, blue color, tested for use with chemotherapy drugs Grand Work Plastic Products Co., Ltd k222892 12/15/2022
powder free nitrile examination gloves (blue), tested for use with chemotherapy drugs and fentanyl citrate Lingshi Hongruida Health Protection Technology Co., Ltd. k223320 11/02/2022
powder free nitrile examination glove (grey) tested for use with chemotherapy drugs and fentanyl citrate Better Care Plastic Technology Co., Ltd k223713 08/07/2023
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 and fentanyl citrate (blue) Syntex Healthcare Products Co., Ltd. k231643 09/08/2023
glove, patient examination, vinyl (powdered) SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. k964321 01/09/1997
h-ray SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. k982720 11/05/1998
disposable powder free vinyl synthetic examination gloves, white color SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. k992860 09/24/1999
sensi-pro, disposable powdered vinyl synthetic examination gloves, white color SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. k992922 10/06/1999
sensi-pro disposable powdered vinyl synthetic examination gloves, beige color SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. k994206 02/07/2000
sensi-pro disposable powder free vinyl synthetic examination gloves, beige color SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. k994222 02/07/2000

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