Cleared Traditional

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)

K210143 · Foshan Nanhai Plus Medical Co, Ltd. · General Hospital
Jul 2021
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K210143 is an FDA 510(k) clearance for the Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3), 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 July 22, 2021, 184 days after receiving the submission on January 19, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K210143 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2021
Decision Date July 22, 2021
Days to Decision 184 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

Similar Devices — FYA Gown, Surgical

All 290
Copioumed AAMI 3 Surgical Gown
K251860 · Copioumed International, Inc. · Feb 2026
Henan Yadu Level 4 Surgical Gowns (Reinforced)
K252301 · Yadu Medical (Henan) Co., Ltd. · Feb 2026
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
K250564 · Yadu Medical (Henan) Co., Ltd. · Dec 2025
ViVi? Toga Premium
K243522 · Thi Total Healthcare Innovation GmbH · May 2025
Dream Medi Sterile Surgical Gown (SurgicalGownUL)
K242937 · Dae Myung Chemical Co., Ltd. (Vietnam) · May 2025
Medline Level 4 Surgical Gown with Breathable Sleeves
K242844 · Medline Industries, LP · Feb 2025