FDA 510(k) Applications Submitted by Fatin Nor Irdina Bt Ahmad Fauzi

FDA 510(k) Number Submission Date Device Name Applicant
K230314 02/06/2023 Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) New Era Medicare Sdn. Bhd.
K221424 05/16/2022 Sterile Surgical Powder Free Latex Glove New Era Medicare Sdn. Bhd.
K221667 06/08/2022 Non Sterile Powder Free Latex Examination Glove New Era Medicare Sdn. Bhd.
K203036 10/05/2020 Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) Central Medicare Sdn Bhd
K213437 10/22/2021 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims Central Medicare Sdn Bhd


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