CoverU Disposable Gown with Tape - Chemo Gown

CoverU Disposable Gown with Tape - Chemo Gown - IL-4036YKTP-CM

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: FYC

Device Name: Gown, Isolation, Surgical

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 878.4040

Third Party Flag: N

Medical Specialty: SU

Code: QSO

Device Name: Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs

Device Class: 2

Physical State: Woven or non-woven fabric

Definition: Medical gowns that are worn by healthcare personnel to protect both the patient and the wearer from transfer of microorganisms, body fluids, and particulate material. In addition, these gowns have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs.

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Medical gowns that are worn by healthcare personnel have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using an appropriate test method.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Body

Regulation Number: 878.4040

Third Party Flag: N

Medical Specialty: SU

Device Id: 94710415369034

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: 04710415369031

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