510(k) Report

510(k) · Cleared

Cleared

Disposable Isolation Gown

K911921510(k) TraditionalCleared May 13, 199113-day reviewClass II21 CFR 878.4040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Liaoning-Usa Corp. · FYB Gown, Patient

Cleared on May 13, 1991 after a 13-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 13, 1991
Review
13 days
Class
Class II
Product code
FYB
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K911921Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FYB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All FYB devices

FYB Gown, Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FYB

FDA has decided no FYB device since 2007.

Median 510(k) review, days · FYB

Too few FYB 510(k)s in any year since 2007 to give a median.

Recalls per year · FYB

No recall names FYB since 2007.

Adverse event reports per year · FYB

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code FYB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Liaoning-Usa Corp.

6 FDA decisions under this applicant name. See the company

  • K905487Various Types of StethoscopesLiaoning-Usa Corp. · 1991
  • K910623Gauze Sponges Absorbent Gauze RollsLiaoning-Usa Corp. · 1991
  • K902625Clinical Thermometer; Rectal/Oral, Inner ArmpitLiaoning-Usa Corp. · 1990
  • K892781Antelope Brand Patient Examination GlovesLiaoning-Usa Corp. · 1989
  • K892774Patient Examination GlovesLiaoning-Usa Corp. · 1989

Recent decisions in FYB

The FYB category page

  • K891820Disposable Medical GownsBioshield, Inc. · 1989
  • K891053Dental BibDispomed, Inc. · 1989
  • K803171Procedure & Recovery Patient SuitAlba Health Care · 1981
  • K801570Shield Disp. Patients Poncho GownsAmerican Convertors Div., American Pharmaseal · 1980
  • K771929Pediatrics GownConvertors · 1977

https://510kreport.com/device/K911921 · printed Nov 6, 2026

Cite this page

510(k) Report. “K911921: Disposable Isolation Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911921

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026