Cleared Traditional

Disposable Surgical Gown (K233068) - FDA 510(k) Clearance

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

K233068 · Nanning Tecbod Biological Technology Co., Ltd. · General Hospital
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Mar 2024
Decision
185d
Days
Class 2
Risk

K233068 is an FDA 510(k) clearance for the Disposable Surgical Gown. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Nanning Tecbod Biological Technology Co., Ltd. (Nanning, CN). The FDA issued a Cleared decision on March 29, 2024 after a review of 185 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 Nanning Tecbod Biological Technology Co., Ltd. devices

Submission Details

510(k) Number K233068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2023
Decision Date March 29, 2024
Days to Decision 185 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 129d · This submission: 185d
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 116
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K233068.
Stryker Steri-Shield 8 Surgical Hoods and Togas
K241272 · Stryker Instruments · Oct 2024
ProPel SG3™ Surgical Gown
K241214 · Standard Textile Co., Inc. · Sep 2024
GCI Surgical Gown
K233571 · George Courey, Inc. · Aug 2024
Surgical Gown (40083)
K233183 · Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. · Feb 2024
Skypro, Surgical Gown 6021
K230707 · Skypro Medical Supplies Company · Oct 2023
Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)
K230610 · Dongguan Shin YI Healthcare Products Factory · Aug 2023