Cleared Traditional

Disposable Isolation Gown

K223467 · Nanning Tecbod Biological Technology Co., Ltd. · General Hospital
Feb 2023
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K223467 is an FDA 510(k) clearance for the Disposable Isolation Gown, a Gown, Isolation, Surgical (Class II — Special Controls, product code FYC), submitted by Nanning Tecbod Biological Technology Co., Ltd. (Naning, CN). The FDA issued a Cleared decision on February 10, 2023, 85 days after receiving the submission on November 17, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K223467 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2022
Decision Date February 10, 2023
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FYC — Gown, Isolation, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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