Cleared Traditional

K911921 - DISPOSABLE ISOLATION GOWN

K911921 is an FDA 510(k) clearance for DISPOSABLE ISOLATION GOWN, manufactured by Liaoning-Usa Corp.. The device is a Class 2 General Hospital device with product code FYB cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K911921 · Liaoning-Usa Corp. · General Hospital
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May 1991
Decision
13d
Days
Class 2
Risk

K911921 is an FDA 510(k) clearance for the DISPOSABLE ISOLATION GOWN. Classified as Gown, Patient (product code FYB), Class II - Special Controls.

Submitted by Liaoning-Usa Corp. (Pasadena, US). The FDA issued a Cleared decision on May 13, 1991 after a review of 13 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Liaoning-Usa Corp. devices

FDA 510(k) Submission Details - K911921

510(k) Number K911921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1991
Decision Date May 13, 1991
Days to Decision 13 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
116d faster than avg
Panel avg: 129d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYB Device Classification - Class 2, Special Controls

Product Code FYB Gown, Patient
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.