Technical Specifications - AAMI Level 3 Liquid Barrier Protection (Moderate fluid and microbial barrier). - Sizes: Regular/large, medium, XL, XXL, XXXL. - Raglan Sleeves, elastic wrist. - Weight: Heavy fabric. - Material (Spunbond/Meltblown/Spunbond)/Polyester film/SMS. - Fully cover the front torso and arms and should tie in the back. - Disposable/Single use. - Muse be sterile for surgely/procedure area use. - Closure - Hook-and-loop, Tape Tab Neck, or Neck ties. - Muse meet FDA standards. - Hood (with/without). - Non-flammable. - Performance Requirements at 4% AQL: AATCC 42 Impact Penetration =< 1.0g, AATCC 127 Hydrostatic Pressure >= 50cm. - Intended Use: The widest range of surgical procedures, where moderate fluid protection is indicated; Mastectomies; Arthroscopic, orthopedic procedures, Endoscopic urological procedures, Transurethral Prostate Resections (TURP), Open gastrointestinal and genitourinary procedures. Licenses & Certifications: - Test report of product. - Certificate of Conformity (CE). - Certificate of Medical Device Registration 2020 (FDA). - Certificate ISO Standard. - Certificate ISO Standard: 9001 - Made in Vietnam.