Cleared Traditional

K223411 - Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (FDA 510(k) Clearance)

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

K223411 · Xiamen Probtain Medical Techology Co., Ltd. · General Hospital
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Jan 2023
Decision
56d
Days
Class 2
Risk

K223411 is an FDA 510(k) clearance for the Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL). Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Xiamen Probtain Medical Techology Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on January 4, 2023 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 Xiamen Probtain Medical Techology Co., Ltd. devices

Submission Details

510(k) Number K223411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2022
Decision Date January 04, 2023
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
72d faster than avg
Panel avg: 128d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYC Gown, Isolation, 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 Peers - FYC Gown, Isolation, Surgical

All 67
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K223411.
Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
K232849 · Owens & Minor (O&M) Halyard, Inc. · May 2024
Copioumed Chemotherapy Isolation Gown
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Disposable Isolation Gown
K223467 · Nanning Tecbod Biological Technology Co., Ltd. · Feb 2023
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
K223304 · Xiamen Probtain Medical Technology Co., Ltd. · Feb 2023
Paneffort AAMI Level 3 Isolation Gown
K212717 · Paneffort, LLC · Nov 2022
CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown
K210414 · Medtecs (Taiwan) Corp. · Oct 2022