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STRYKER T4 URETHANE HOOD - Stryker T4 Urethane Pullover Toga

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022162

by Stryker Instruments

Identifiers

510(k) Number
K022162 FDA 510(k)
FDA Product Code
FYA FDA 510(k)
Models / Variants
Stryker T4 Urethane Hood FDA 510(k)
Stryker T4 Urethane Zipper Toga FDA 510(k)
Stryker T4 Urethane Pullover Toga FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4040 FDA 510(k)
Regulation Number
878.4040 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Stryker T4 Urethane Hood, Zipper Toga, and Pullover Toga are sterile, single-use surgical drapes designed to serve as protective barriers for surgical personnel. These items are intended to shield against contamination from infectious body fluids and microorganisms during operative procedures, maintaining a sterile field for both patient and staff. Constructed from urethane material, they provide a flexible yet durable solution for surgical environments requiring enhanced protection.

These components are supplied as non-sterile items and must be sterilized prior to use, typically via ethylene oxide or gamma irradiation. They are classified under product code FYA and are intended for use in general and plastic surgery settings. Each item is reusable only after proper cleaning and reprocessing, adhering to established infection control protocols. The devices are FDA-cleared under 510(k) number K022162, with a special clearance designation for substantial equivalence.

Frequently asked questions

What are the Stryker T4 Urethane Hood, Zipper Toga, and Pullover Toga designed for?

These items are sterile surgical drapes intended to create protective barriers for surgical personnel during operative procedures. They shield against contamination from infectious body fluids and microorganisms, ensuring a sterile field for both patients and staff. The urethane material offers flexibility and durability, making them suitable for environments requiring enhanced protection in general and plastic surgery settings.

Are these drapes single-use or reusable?

The Stryker T4 Urethane Hood, Zipper Toga, and Pullover Toga are not single-use. They are supplied in a non-sterile state and must be sterilized via ethylene oxide or gamma irradiation before use. After use, they can be reused only after proper cleaning and reprocessing, following strict infection control protocols to maintain safety and sterility.

What sterilization methods are recommended for these drapes?

These drapes are designed to be sterilized using ethylene oxide or gamma irradiation before their first use. The manufacturer does not specify alternative methods, so adherence to these validated processes ensures proper decontamination and readiness for surgical use.

Are these drapes FDA-cleared, and for what procedures?

Yes, these drapes are FDA-cleared under 510(k) number K022162 with a special clearance designation for substantial equivalence. They are classified under product code FYA and are intended for use in general and plastic surgery settings, where maintaining a sterile field is critical.

How should these drapes be stored before sterilization?

Since these drapes are supplied in a non-sterile state, they should be stored in a clean, dry environment protected from dust, moisture, and direct sunlight. Proper packaging (if provided) should remain intact until sterilization to prevent contamination. After sterilization, they must be stored in a way that preserves sterility until use, such as in sealed, sterile barriers.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Stryker T4 Urethane Hood; Stryker T4 Urethane Zipper Toga; Stryker T4 ..., Stryker T4 Hood, Stryker T4 Zippered Toga, Stryker T4 Pullover Toga ..., Stryker T4 Urethane Hood; Stryker T4 Urethane Zipper Toga; Stryker T4 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Stryker Instruments

Sources (1)

  • FDA 510(k) K022162 24 fields · synced Oct 5, 2026