Skip to content

Thantex Specialties, Inc.

United StatesFDA applicant, unverified

Devices
21

What Thantex Specialties, Inc. makes

Thantex Specialties, Inc. manufactures surgical isolation barriers, including surgeon’s caps, hoods, bouffant caps, drapes, gowns, and vests, as well as x-ray detectable variants for radiology safety. The company also produces sharps management systems designed for surgical and procedural settings to improve needle and blade safety. Products are tailored for operating room use, with some items featuring reinforced layers for contamination control.

The portfolio includes Class I, Class II, and Unclassified devices, with submissions recorded in the FDA’s 510(k) registry. Products are listed under U.S. regulatory requirements, and the company operates from the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue21

Newest first, rows 1-21 of 21

Search and filter all 21 devices
Skip device list

  • Isolyser Orex Surgeon's Caps, Hoods, Bouffant Caps Ref K942200

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Orex(R) O.r Equipment Drapes Ref K945755

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Isolyser Sharps Management System Sms Ref K943626

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Orex (18X18 X-Ray Detectable) Ref K940766

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Orex Surgeon's Vest Ref K961083

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Isolyser Ref K940765

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Orex Isolation Gown Ref K945223

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Isolyser (8X4 12 Ply X-Ray Detectable) Ref K940763

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Orex Ref K940716

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Orex Ref K940764

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Orex (12X12 X-Ray Detectable) Ref K940767

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Orex Surgical Drapes Ref K944859

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Isolyser (18X18 X-Ray Detectable) Ref K940762

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Isolyser (4X18) X-Ray Detectable Ref K940757

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Orex O.R. Towel Ref K942228

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Orex Surgeon's Gown Ref K944827

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Isolyser (X-Ray Detectable) Ref K940756

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Isolyer (4X4, 12 Ply) Ref K940754

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Isolyser Sds Sharps Container Ref K970547

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Orex Medical Bedding Ref K944953

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Orex Shoe Covers Ref K943034

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-21 of 21

Frequently asked questions

How many devices does Thantex Specialties, Inc. have in the registry?

The registry currently lists 21 devices for Thantex Specialties, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Thantex Specialties, Inc.'s devices?

Among its 21 most recently registered devices, Thantex Specialties, Inc. has devices listed in FDA 510(k) (21 devices).

What risk classes do Thantex Specialties, Inc.'s devices fall under?

Among its 21 most recently registered devices, the classes recorded for Thantex Specialties, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Thantex Specialties, Inc. in the registry?

The most recently registered devices listed for Thantex Specialties, Inc. include ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS, OREX(R) O.R EQUIPMENT DRAPES, ISOLYSER SHARPS MANAGEMENT SYSTEM SMS and OREX (18X18 X-RAY DETECTABLE).

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