LAB COAT WHT LG SPP

LAB COAT WHT LG SPP
Cypress - 34-360

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.

No Data Available

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: 20815555022001

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10815555023988

Package Quantity: 30

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 10815555023988

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

Device Id: 00815555024056

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