Stronghold SMS Reinforced Surgical Gown (Non-Sterile)-XL

Primary DI

00850037694068

Brand

Stronghold SMS Reinforced Surgical Gown (Non-Sterile)-XL

Company

The Stronghold Group LLC

Model

SC300XL

Device description

The Stronghold SMS Reinforced Gown is a device that is 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. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

Published

2021-11-25

Public version status

New

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

false

OTC

false

Sterile

false

Single use

true