FDA 510(k)

Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)

K番号: K212613 · 2021-12-21

決定日2021-12-21

製品コードLZA

諮問委員会HO

決定Substantially Equivalent

医療機器の概要

Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Koon Seng Sdn Bhd. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K212613. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)?

Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Koon Seng Sdn Bhd. The 510(k) number is K212613.

When did Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) received FDA 510(k) clearance on 2021-12-21, under 510(k) number K212613.

Who is the listed applicant for Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)?

The FDA 510(k) record lists Koon Seng Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)?

The FDA product code for Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) is LZA.

申請者としてKoon Seng Sdn Bhdを記載するその他の記録

K171171KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)

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