FDA 510(k)

紫ローズニトリル粉体不使用患者検査手袋、非無菌

K番号: K222721 · 2022-10-18

決定日2022-10-18

製品コードLZA

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

Violet Nitrile Powder Free Patient Examination Glove, Non Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Safeskin Retailing (Hk) Limited. It received FDA 510(k) clearance on 2022-10-18 under 510(k) number K222721. 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 Violet Nitrile Powder Free Patient Examination Glove, Non Sterile?

Violet Nitrile Powder Free Patient Examination Glove, Non Sterile is a medical device that received FDA 510(k) clearance on 2022-10-18. The listed applicant is Safeskin Retailing (Hk) Limited. The 510(k) number is K222721.

When did Violet Nitrile Powder Free Patient Examination Glove, Non Sterile receive FDA 510(k) clearance?

Violet Nitrile Powder Free Patient Examination Glove, Non Sterile received FDA 510(k) clearance on 2022-10-18, under 510(k) number K222721.

Who is the listed applicant for Violet Nitrile Powder Free Patient Examination Glove, Non Sterile?

The FDA 510(k) record lists Safeskin Retailing (Hk) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Violet Nitrile Powder Free Patient Examination Glove, Non Sterile?

The FDA product code for Violet Nitrile Powder Free Patient Examination Glove, Non Sterile is LZA.

申請者としてSafeskin Retailing (Hk) Limitedを記載するその他の記録

K222715ブラックニトリル粉無しの患者検査用手袋、非無菌 K222720ブルー・ニトリル・パウダーフリー・パッショナート・エクサミネーショングローブ、非無菌 K222713ホワイトニトリル粉無しの患者検査用手袋、非無菌

公式ソース

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