Hood
Flyte - 0408800000NS
Device Description
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.
Environmental Conditions
- 106.00
- 70.00
- 75.00
- 20.00
- 40.00
- 10.00
- 106.00
- 50.00
- 75.00
- 10.00
- 40.00
- -20.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice 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
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