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    K Number
    K140588
    Device Name
    FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
    Manufacturer
    STRYKER CORPORATION
    Date Cleared
    2014-06-26

    (111 days)

    Product Code
    FXY
    Regulation Number
    878.4040
    Type
    Special
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K063005
    Why did this record match?
    Device Name :

    FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Stryker Flyte Hybrid Hoods are components of a personal protection system and are intended to protect the patient, healthcare personnel, and operating room personel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.

    The devices are provided sterile and for single use only.

    Device Description

    The Stryker Flyte Hybrid Hoods are intended to be worn over a Flyte Helmet to provide protection to the user's face and head region during surgery. Hoods are worn in conjunction with surgical gowns where the hood material extends beyond the user's upper back and shoulders, while the surgical gown covers the lower portion of the hood up to the user's neck.

    The Stryker Flyte Hybrid Hood is comprised of 3 main parts: Hood, Filter and Lens. Stryker Flyte Hybrid Hoods are available with either a standard or peel away lens.

    The devices are prescription devices, provided sterile and single use only.

    AI/ML Overview

    This document describes the acceptance criteria and performance data for the Stryker Flyte Hybrid Hoods.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Test PerformedAcceptance CriteriaReported Device Performance (Conclusion)
    CO₂ Level Inside the Hood (Internal test)CO₂ Level
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