Cleared Traditional

Plus Medical Isolation Gown Level 3

K212698 · Foshan Nanhai Plus Medical Co, Ltd. · General Hospital
Mar 2022
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K212698 is an FDA 510(k) clearance for the Plus Medical Isolation Gown Level 3, a Gown, Isolation, Surgical (Class II — Special Controls, product code FYC), submitted by Foshan Nanhai Plus Medical Co, Ltd. (Foshan, CN). The FDA issued a Cleared decision on March 2, 2022, 189 days after receiving the submission on August 25, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K212698 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2021
Decision Date March 02, 2022
Days to Decision 189 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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