Cleared Traditional

Plus Medical Chemotherapy Gown

K211036 · Foshan Nanhai Plus Medical Co, Ltd. · General Hospital
May 2022
Decision
392d
Days
Class 2
Risk

About This 510(k) Submission

K211036 is an FDA 510(k) clearance for the Plus Medical Chemotherapy 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 4, 2022, 392 days after receiving the submission on April 7, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K211036 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2021
Decision Date May 04, 2022
Days to Decision 392 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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