Product code OEA

Device name

Non-Surgical Gown

Medical specialty

General, Plastic Surgery

Device class

1

Regulation number

878.4040

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material

Source

FDA openFDA device classification dataset