Hood

Hood
Flyte - 0408800000NS

A garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a single-use garment.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OEA

Device Name: Non-Surgical Gown

Device Class: 1

Physical State: A gown is made of fabric material, either non-woven or woven

Definition: A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material

Submission Type ID: 4

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Serves as physical barrier to the transfer of microorganisms, body fluids and particulate material. Provides minimal or low levels of barrier protection (e.g., ANSI/AAMI PB70 Level 2 or below)

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: A gown covers the torso and clothing and poses a physical barrier to the transfer of microorganisms, body fluids and particulate material

Regulation Number: 878.4040

Third Party Flag: N

Medical Specialty: SU

Device Id: 37613327514064

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 07613327514063

Package Quantity: 32

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: pack

Device Id: 07613327514063

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A