Cleared Traditional

K221559 - Disposable Surgical Gown

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

K221559 is an FDA 510(k) clearance for Disposable Surgical Gown, manufactured by Stringking. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 268-day FDA review.

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

FDA 510(k) Submission Details - K221559

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.

FYA Device Classification - Class 2, Special Controls

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 165
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