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Allegiance Healthcare Corp.

United StatesFDA applicant, unverified

Devices
64
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Allegiance Healthcare Corp. makes

Allegiance Healthcare Corp. manufactures single-use medical barriers, including nitrile and latex examination gloves, sterile surgical gloves, surgical gowns, drapes, and impervious shoe covers. The company also produces ventilator circuits, breathing circuit filters, and flexible vascular clamps for surgical and critical care settings.

The portfolio includes devices classified as Class I and Class II under FDA regulations, with many products listed via the 510(k) pathway. Allegiance Healthcare Corp. is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

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FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Allegiance Healthcare Corp., initiated on 2003-01-22. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2003

    • 22 Jan 2003 Z-0576-03 Unclassified (pre-2012) Terminated The product labeled as sterile had not been through its sterilzation cycle. Distribution: New Jersey, Georgia, Washington and Florida Submission number: K002419

Frequently asked questions

How many devices does Allegiance Healthcare Corp. have in the registry?

The registry currently lists 64 devices for Allegiance Healthcare Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Allegiance Healthcare Corp.'s devices?

Among its 50 most recently registered devices, Allegiance Healthcare Corp. has devices listed in FDA 510(k) (50 devices).

What risk classes do Allegiance Healthcare Corp.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Allegiance Healthcare Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Allegiance Healthcare Corp.?

FDA recall records list 1 recall initiated by Allegiance Healthcare Corp., the most recent initiated on 22 Jan 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Allegiance Healthcare Corp. in the registry?

The most recently registered devices listed for Allegiance Healthcare Corp. include NITRILE POWDER-FREE EXAMINATION GLOVES, POWDER FREE STERILE LATEX EXAMINATION GLOVES, STERILE NITRILE POWDER-FREE EXAMINATION GLOVES and ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS).

Generated automatically from registry data and not verified by a human reviewer.