FDA 510(k)

隔離衣 (S, M, L, XL, XXL (黃色，藍色))

K 號：K221027 · 2022-08-12

申請人Allmed Medical (Hubei) Protective Products Co., Ltd.

決定日期2022-08-12

產品代碼FYC

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) is the device name listed in this FDA 510(k) record. The listed applicant is Allmed Medical (Hubei) Protective Products Co., Ltd.. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K221027. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))?

Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Allmed Medical (Hubei) Protective Products Co., Ltd.. The 510(k) number is K221027.

When did Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) receive FDA 510(k) clearance?

Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) received FDA 510(k) clearance on 2022-08-12, under 510(k) number K221027.

Who is the listed applicant for Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))?

The FDA 510(k) record lists Allmed Medical (Hubei) Protective Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))?

The FDA product code for Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) is FYC.

其他以 Allmed Medical (Hubei) Protective Products Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K221637外科袍（無菌）；外科袍（非无菌）

相關器械（代碼：FYC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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