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Latex Ind., Inc.

United StatesFDA applicant, unverified

Devices
14

What Latex Ind., Inc. makes

Latex Ind., Inc. manufactures urinary catheterization products, including male external catheters, Foley catheters with Teflon coatings, urinary drainage bags, and catheterization trays. Their portfolio also covers bladder retention kits, urological catheters, and Foley kits in various sizes (5cc and 30cc). Additional offerings include catheter care trays and sterile bladder kits designed for clinical use.

The company’s devices are regulated under FDA’s Class I and Class II classifications, with submissions recorded via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.

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

Catalogue14

Newest first, rows 1-14 of 14

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  • Akron Male External Catheter Ref K781433

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

  • Catheter, Akron Foley Teflon Ref K781751

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

  • Akron Urinary Drainage Bat Ref K812058

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

  • Bladder Retention-Cathetherizationtray Ref K772277

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

  • Bladder Cath Kit W/Out Catheter Ref K780268

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

  • Bladder Kit - 734000 Ref K772341

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

  • Robinson Kit - 750014 & 750016 Ref K772342

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

  • Cath-Care Tray Ref K771652

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

  • Bladder Retention Catheterization Tray Ref K791674

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

  • Urological Catheters Ref K810281

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

  • Akro-Sil Foley Kit 5cc Ref K771651

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

  • Akro-Sil Foley Kit 30cc Ref K771650

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

  • Cath Tray W/Out Catheter Ref K780267

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

  • Catheterization Kit 732016-732018 Ref K772340

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

Rows 1-14 of 14

Frequently asked questions

How many devices does Latex Ind., Inc. have in the registry?

The registry currently lists 14 devices for Latex Ind., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Latex Ind., Inc.'s devices?

Among its 14 most recently registered devices, Latex Ind., Inc. has devices listed in FDA 510(k) (14 devices).

What risk classes do Latex Ind., Inc.'s devices fall under?

Among its 14 most recently registered devices, the classes recorded for Latex Ind., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Latex Ind., Inc. in the registry?

The most recently registered devices listed for Latex Ind., Inc. include AKRON MALE EXTERNAL CATHETER, CATHETER, AKRON FOLEY TEFLON, AKRON URINARY DRAINAGE BAT and BLADDER RETENTION-CATHETHERIZATIONTRAY.

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