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The AAMI4 Isolation Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed AAMI4 Isolation Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB 70:2012, Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The AAMI4 Isolation Gown is a single use, disposable medical device provided non-sterile.

The proposed device, AAMI4 Isolation Gown, is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed device is a single use, disposable medical device provided non-sterile. There is one model of AAMI4 Isolation Gown: 4015T. And the proposed AAMI4 Isolation Gown is available in one product size: U. The barrier protection level for AAMI4 Isolation Gown meets AAMI Level 4. The proposed device consists of five components: 1) Basic Gown, 2) Belt, 3) Cuff, 4) Hook-and-loop Velcro and 5) Seam Sealing Tape. The gown is made of polypropylene and polyethylene laminating. The gown is blue in color.

The 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 masks are intended for use in infection control practices to reduce the potential exposure to bloody fluids. This is a single-use, disposable device, provided non-sterile. XX0009 Ear loop Level: Level 1, Level 2 and Level 3 XX0008 Tie-on Level: Level 1, Level 2 and Level 3 XX0006 Tie-on with shield Level: Level 1, Level 2 and Level 3 XX0005 Ear loop with shield Level: Level 1, Level 2 and Level 3

The surgical masks are single use, flat-pleated masks that are provided in blue. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter is made of one layer of meltblown polypropylene filter. The Surgical Masks are available in four types due to different configurations, including ear loop, tie-on, ear loop with shield and tie-on with shield. Detail configurations of them are presented in Table 1 Surgical Masks Description. The ties are made of spunbond polypropylene and the ear loops are made of spandex. The shield is made of PET. The nose piece is made of iron wire and polypropylene. Users can adjust the nose piece according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The proposed devices are provided in non-sterile. The proposed devices contain four (4) types of masks: XX0009, XX008, XX0006 and XX0005. Each of these types have three different levels, level 2, and level 3. Therefore, the proposed devices have 12 models in toto, and detailed model information is provided in Table 1.