Maddox Defense Surgical Gowns (Sterile) - 510K

Maddox Defense Surgical Gowns (Sterile) - 510K


Surgical Gowns, Reinforced LEVEL 3 & 4



• SMS Material reinforced with Non-Woven Polypropylene (PP) and Polyethylene (PE) Film

• Single Use (Disposable)

• Sterile: Sterilized by EO (Ethylene Oxide). Product is sterile unless the package has been damaged or opened

• Store at room temperature/general warehouse conditions

• Established at 5 years based upon sterile packaged product aging studies and normal warehouse storage conditions.

After 5 years, the product should be performance tested to ensure compliance to specifications

• Not made with natural rubber latex

Certifications: • AAMI Level 3 & 4 Per ANSI/AAMI PB70:2012

• US FDA: Class 2

• MDSAP Compliant