Cleared Traditional

K241214 - ProPel SG3™ Surgical Gown

K241214 is an FDA 510(k) clearance for ProPel SG3 Surgical Gown, manufactured by Standard Textile Co., Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K241214 · Standard Textile Co., Inc. · General Hospital
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Sep 2024
Decision
133d
Days
Class 2
Risk

K241214 is an FDA 510(k) clearance for the ProPel SG3™ Surgical Gown. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Standard Textile Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 10, 2024 after a review of 133 days - within the typical 510(k) review window.

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 Standard Textile Co., Inc. devices

FDA 510(k) Submission Details - K241214

510(k) Number K241214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2024
Decision Date September 10, 2024
Days to Decision 133 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
4d slower than avg
Panel avg: 129d · This submission: 133d
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 Consultant

RQM+
Catherine Kang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FYA Gown, Surgical

All 211
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K241214.
Dream Medi Sterile Surgical Gown (SurgicalGownUL)
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GCI Surgical Gown
K233571 · George Courey, Inc. · Aug 2024
Disposable Surgical Gown
K233068 · Nanning Tecbod Biological Technology Co., Ltd. · Mar 2024
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K233183 · Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. · Feb 2024