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Protective gown AAMI Level 4 is intended to protect health care personnel and patients from transfer of microorganisms, body fluids and particulate material. The Protective Gowns is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.

Protective Gown AAMI Level 4

The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used up to 365 days post sterilization. Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using: a) 100% ethylene oxide (EO) with a concentration of 725 - 735 mg/l at 131 F/55°C and 40%-80% relative humidity for 60 minutes. b) Exhausting the EO gas vacuum depth: 157 mBar to 160 mBar c) Aeration time: 12 hours d) Aeration temperature: 55℃ e) Aeration pressure : 841 mBar to 864 mBar

Sterilization Wrap is single use, non-sterile provide. It is divided into single and double layers, with double layer edges closed by ultrasonic suture. The sterilization Wrap is made from 100% polypropylene spunbond- meltblown - spunbond (SMS), not made with natural rubber latex.

The Isolation Gown AAMI Level 3 is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities(ANSI/AAMI PB70). The Isolation Gown is single use, disposable medical device provided non-sterile.

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The Procedure Masks / Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Procedure Masks (68-8506-G (Green, ear loop, level 1) & 68-8508-G (Green, ear loop, level 3) are single use, three-layer, flat-folded masks with ear loops, and nose wire. The Procedure Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ear loops welded are used to keep the mask close to the nose. The elastic ear loops are not made with natural rubber latex. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The procedure masks will be provided in green. The Surgical Masks (68-8536-B (Blue, tie-on, level 1) & 68-8538-B (Blue, tie-on, level 3) are single use, threelayer, flat-folded masks with Ties, and nose wire. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ties welded are used to keep the mouth and the nose. The tie is made of spunbond polypropylene. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The surgical masks will be provided in Blue. The procedure masks are sold non-sterile and are intended to be single use, disposable device.