Cleared Traditional

Plus Medical Cover Gown

K213177 · Foshan Nanhai Plus Medical Co, Ltd. · General Hospital
May 2022
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K213177 is an FDA 510(k) clearance for the Plus Medical Cover Gown, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Foshan Nanhai Plus Medical Co, Ltd. (Foshan, CN). The FDA issued a Cleared decision on May 11, 2022, 225 days after receiving the submission on September 28, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K213177 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2021
Decision Date May 11, 2022
Days to Decision 225 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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