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Central Medicare Sdn Bhd

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories2
Latest FDA decision2023-10-02
TypeNumberDevice NameCodeDateActions
510(k) K230681 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and FentanylLZA2023-10-02 View
510(k) K223752 Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and FentanylLZA2023-07-24 View
510(k) K230875 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance ClaimsLZA2023-07-20 View
510(k) K230564 Green Non Sterile Powder Free Nitrile Examination GlovesLZA2023-05-23 View
510(k) K213437 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance ClaimsLZA2022-04-11 View
510(k) K211022 Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.LZA2021-12-22 View
510(k) K203036 Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)LZA2021-05-07 View
510(k) K183149 Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance ClaimLZC2019-07-04 View
510(k) K173942 Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsLZC2018-03-05 View
510(k) K172642 Orange Non Sterile Powder Free Nitrile Examination GlovesLZC2017-11-28 View
510(k) K172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsLZC2017-11-13 View
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