Cleared Traditional

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)

K222480 · Foshan Nanhai Plus Medical Co, Ltd. · General Hospital
Nov 2022
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K222480 is an FDA 510(k) clearance for the Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2), 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 November 14, 2022, 89 days after receiving the submission on August 17, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K222480 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 2022
Decision Date November 14, 2022
Days to Decision 89 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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