Cleared Traditional

K141467 - SURGICAL GOWN

K141467 is an FDA 510(k) clearance for SURGICAL GOWN, manufactured by Xuchang Zhengde Environstar Medical Products Co.,L. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K141467 · Xuchang Zhengde Environstar Medical Products Co.,L · General Hospital
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Mar 2015
Decision
275d
Days
Class 2
Risk

K141467 is an FDA 510(k) clearance for the SURGICAL GOWN. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Xuchang Zhengde Environstar Medical Products Co.,L (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on March 5, 2015 after a review of 275 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 Xuchang Zhengde Environstar Medical Products Co.,L devices

FDA 510(k) Submission Details - K141467

510(k) Number K141467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2014
Decision Date March 05, 2015
Days to Decision 275 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 129d · This submission: 275d
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 168
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K141467.
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TOTAL SHIELD SURGICAL
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T4/T5 HYTREL TOGAS
K121664 · Stryker Corporation · Mar 2014