Cleared Traditional

Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown (K211422) - FDA 510(k) Clearance

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

K211422 · Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · General Hospital
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Jul 2021
Decision
56d
Days
Class 2
Risk

K211422 is an FDA 510(k) clearance for the Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinf.... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. (Siyang, CN). The FDA issued a Cleared decision on July 2, 2021 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. devices

Submission Details

510(k) Number K211422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2021
Decision Date July 02, 2021
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 129d · This submission: 56d
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

Mid-Link Consulting Co, Ltd.
Diana Hong

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 K211422.
Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)
K210143 · Foshan Nanhai Plus Medical Co, Ltd. · Jul 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
Medline Orbis Surgical Gown
K202447 · Medline Industries, Inc. · Apr 2021
Medical Surgical Gowns
K202844 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · Jan 2021
Surgical Gown (Sterile), Surgical Gown (Non-sterile)
K202706 · B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · Dec 2020