Cleared Traditional

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) (K210143) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K210143 is an FDA 510(k) clearance for the Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3). Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Foshan Nanhai Plus Medical Co, Ltd. (Foshan, CN). The FDA issued a Cleared decision on July 22, 2021 after a review of 184 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Foshan Nanhai Plus Medical Co, Ltd. devices

Submission Details

510(k) Number K210143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 129d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
Olivia Meng

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FYA Gown, Surgical

All 105
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K210143.
Surgical Gown
K211077 · Wujiang Tutaike Textiles & Finishing Co., Ltd. · Oct 2021
Disposable Surgical Gowns
K202532 · Anhui Medpurest Medical Technology Co.,Ltd · Aug 2021
Disposable Surgical Gown
K210510 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · Aug 2021
AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown
K210688 · O&M Halyard, Inc. · Jul 2021
Surgical Gowns
K210215 · Jiangsu Province Jianerkang Medical Dressing Co., Ltd. · Jul 2021
Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown
K211422 · Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · Jul 2021