GOWN, COVER REG W/KNIT CUFF SPP
Cypress - 31-100
Device Description
A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.
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: 10815555023940
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: 20815555020892
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