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American Threshold Industries, Inc.

United StatesFDA applicant, unverified

Devices
20

What American Threshold Industries, Inc. makes

American Threshold Industries, Inc. manufactures single-use personal protective equipment (PPE) and infection control products, including surgical masks, barrier gowns (both backless and singles), surgical caps, shoe covers, and antimicrobial mattress and pillow covers. Their portfolio also includes OR/CS wraps, infection control towels, and modified surgical eyeshield masks designed for medical and surgical environments.

The company’s products are regulated under FDA’s Class I and Class II device classifications, with many authorised via the 510(k) pathway. These items are listed in the FDA’s 510(k) database, reflecting their compliance with US regulatory requirements. The manufacturer operates from the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue20

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  • Surgical Mask Ref K801036

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

  • Or/Cs Wrap Ref K810646

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

  • Disposable Shoe Cover Ref K894383

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

  • Barrier Gown, Kool-Gard Backless Gown Ref K952115

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

  • Infection Control Towel Ref K822484

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

  • Kool Gard Singles Gown Ref K952114

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

  • Surgeon's Cap Ref K953879

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

  • Mattress Cover, Anti-Microbial Ref K832483

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

  • Bouffant Cap Ref K953878

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

  • Modification Of Surgical Eyeshield Mask Ref K934085

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

  • Pillow Cover, Anti-Microbial Ref K832486

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

  • Isolation Mask I.C.S. Ref K831062

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

  • Cover Gown Ref K952116

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

  • Disposable O.R. Towel, Sterile Ref K915740

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

  • Draw Sheet, Anti-Microbial Ref K832487

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

  • Disposable O.R. Towel Ref K912110

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

  • Nova Gauze Ref K830473

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

  • Secure-Wrap (Tm) Sterilization Wrap Ref K971483

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

  • Disposable Isolation Gown Ref K851823

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

  • Nova Gauze(R) Disposable Nonwoven Sponges, Sterile Ref K915530

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

Rows 1-20 of 20

Frequently asked questions

How many devices does American Threshold Industries, Inc. have in the registry?

The registry currently lists 20 devices for American Threshold Industries, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list American Threshold Industries, Inc.'s devices?

Among its 20 most recently registered devices, American Threshold Industries, Inc. has devices listed in FDA 510(k) (20 devices).

What risk classes do American Threshold Industries, Inc.'s devices fall under?

Among its 20 most recently registered devices, the classes recorded for American Threshold Industries, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from American Threshold Industries, Inc. in the registry?

The most recently registered devices listed for American Threshold Industries, Inc. include SURGICAL MASK, OR/CS WRAP, DISPOSABLE SHOE COVER and BARRIER GOWN, KOOL-GARD BACKLESS GOWN.

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