Cleared Traditional

K223411 - Disposable Isolation Gowns (S

K223411 is an FDA 510(k) clearance for Disposable Isolation Gowns (S, manufactured by Xiamen Probtain Medical Techology Co., Ltd.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K223411 · Xiamen Probtain Medical Techology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K223411

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
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYC Device Classification - Class 2, Special Controls

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 33
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K223411.
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Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
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CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown
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