Cleared Traditional

Disposable Surgical Gown, Level 4 (K221559) - FDA 510(k) Clearance

Also marketed or referenced as:
Disposable Surgical Gown, Level 3

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

K221559 · Stringking · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
268d
Days
Class 2
Risk

K221559 is an FDA 510(k) clearance for the Disposable Surgical Gown, Level 4. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Stringking (Gardena, US). The FDA issued a Cleared decision on February 23, 2023 after a review of 268 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 Stringking devices

Submission Details

510(k) Number K221559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2022
Decision Date February 23, 2023
Days to Decision 268 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
139d slower than avg
Panel avg: 129d · This submission: 268d
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 Peers - FYA Gown, Surgical

All 105
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K221559.
Surgical Gown
K222999 · Hubei Woozon Healthcare Co., Ltd. · Jun 2023
High Protection Surgical Gown
K222456 · 3A Medical Products Co., Ltd. · Mar 2023
Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
K223401 · Xiamen Probtain Medical Techology Co., Ltd. · Mar 2023
Surgical Gown
K213844 · Bayteks Teknik Tekstil San. VE Tic. A.S. · Feb 2023
SEJONG Surgical Gown Soft
K220435 · Sejong Healthcare Co., Ltd. · Feb 2023
Surgical Gown
K222403 · Guangzhou Fuzelong Hygiene Material Co., Ltd. · Jan 2023