FDA Certified Disposable Non-Surgical Isolation Gown

Product Details

FDA Certified Disposable Non-Surgical Isolation Gown

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Regulation Description: Surgical Apparel

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

Made of fabric material

Serves as a physical barrier to the transfer of microorganisms, body fluids and particulate material. Level of barrier protection is nonspecific.

This isolation gown covers the torso and clothing and poses a physical barrier to the transfer of microorganisms, body fluids and particulate material

Regulation Medical Specialty: General & Plastic Surgery

Product Code: OEA (non-surgical isolation gown Surgical apparel)

Submission Type: 510(K) Exempt

Regulation Number: 878.4040

Device Class: 1