SHOE COVER, NON
Cypress - 35-55
Device Description
A loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.
Environmental Conditions
No Data Available
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: 10815555024022
Device Type: Unit of Use
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
Device Id: 20815555020281
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