FDA 510(k)

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

K番号: K220431 · 2022-06-17

決定日2022-06-17

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

Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile is the device name listed in this FDA 510(k) record. The listed applicant is One Glove Industrial Sdn Bhd. It received FDA 510(k) clearance on 2022-06-17 under 510(k) number K220431. 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 Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile?

Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile is a medical device that received FDA 510(k) clearance on 2022-06-17. The listed applicant is One Glove Industrial Sdn Bhd. The 510(k) number is K220431.

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

Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile received FDA 510(k) clearance on 2022-06-17, under 510(k) number K220431.

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

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

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

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

申請者としてOne Glove Industrial Sdn Bhdを記載するその他の記録

K220429紫ローズニトリル粉を含まない患者検査手袋、非無菌 K220427ホワイトニトリル非粉体患者検査手袋、非無菌 K220428ブラックニトリル粉無しの患者検査用手袋、非無菌

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