Cleared Traditional

K112796 - SURGICAL GOWN (EO STERILIZED)

K112796 is an FDA 510(k) clearance for SURGICAL GOWN (EO STERILIZED), manufactured by Cobes Industries Co., Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 717-day FDA review.

K112796 · Cobes Industries Co., Ltd. · General Hospital
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Sep 2013
Decision
717d
Days
Class 2
Risk

K112796 is an FDA 510(k) clearance for the SURGICAL GOWN (EO STERILIZED). Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Cobes Industries Co., Ltd. (Dover, US). The FDA issued a Cleared decision on September 12, 2013 after a review of 717 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Cobes Industries Co., Ltd. devices

FDA 510(k) Submission Details - K112796

510(k) Number K112796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2011
Decision Date September 12, 2013
Days to Decision 717 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
588d slower than avg
Panel avg: 129d · This submission: 717d
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
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