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Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following: A) Pre-vacuum Steam: 134℃ for 4 minutes, 30 minutes dry time. B) Ethylene Oxide Sterilization: 100% Ethylene Oxide (EO) with a concentration of 360-363 mg/L @ 54°C and 40% relative humidity for 480 minutes, 24 hours aeration time at 42 ℃ Model: ZSW1610, ZSW 1611. Material: 45gms SMS, 54gms SMS. Color of wrap: Pink/Blue (double layers). Size (inches): 12*12, 15*15, 18*18, 20*20, 24*24, 30*30, 36*36, 40*40, 45*45, 48*48, 54*54, 72*54. The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post sterilization. Types of medical devices to be sterilized in the Pre-Vacuum Steam Sterilization and Ethylene Oxide Sterilization: General purpose non-lumened reusable metal and nonmetal devices with stainless steel diffusion restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments etc. Models validated for both sterilization methods with stainless steel as part of the load, which with a maximum weight of each types, range from 21bs to 9lbs, which dependent on each model's size. For size2*12, 15*15, 18*18, maximum weight is 216, for 20*20, 36*36, 40*40, 45*45, 48*48, maximum weight is 6lb, and for 54*54, 72*54, maximum weight is 9lb.

Sterilization Wrap is square or rectangular three-layer (SMS) non-woven sheet which manufactured with Polypropylene spunbond-meltblown-spunbond (SMS) fabric. Sterilization wrap provides a strong barrier which protects against cuts, tears with particularly device sets. The device is designed to be implemented as an outer sterilization wrap which allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post Pre-Vacuum Steam Sterilization or Ethylene Oxide Sterilization. Sterilization Wrap is two-layer sheet which ultrasonically bonded blue and pink nonwoven sheet together along two edges, thus for convenient simultaneous wrapping. Sterilization Wrap separated into two distinct types depending on different grams of weight of material, for ZSW 1610, it is two 45gsm SMS non-woven sheet ultrasonically bonded together, and for model ZSW 1611, it is two 54gsm SMS sheet. Each model contains series specification, including 12 Sizes (inches): 12*12, 15*15, 18*18, 20*20, 24*24, 30*30, 36*36, 40*40, 45*45, 48*48, 54*54, 72*54. With non-lumened reusable metal and nonmetal devices as part of the load, which with a maximum weight of each type, range from 21bs to 9lbs, which dependent on each model's size.

The Surgical Masks (model: ZSFM 23, ZSFM 24) 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 blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The proposed device (model: ZSFM 23) is blue color, four-layer, and flat pleated type mask, utilizing tie-on way for wearing, and it has nose clips design for fitting the face mask around the nose. The proposed device (model: ZSFM 24) is blue color, three-layer, and flat pleated type mask, utilizing ear loops way for wearing, and it has nose clips design for fitting the face mask around the nose. The proposed device (model: ZSFM 23) is manufactured with four layers, the inner and outer layers are made of polypropylene non-woven fabric, and the two middle layers are made of polypropylene Melt blown non-woven fabric. The proposed device is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of polypropylene non-woven fabric. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire. The proposed device (model: ZSFM 24) is manufactured with three layers, the inner and outer layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene Melt blown non-woven fabric. The proposed device is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Spandex. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire. The surgical masks will be provided in blue. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.

The Surgical Isolation Gown 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 Surgical 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. The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.

The Proposed device is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC and is a single use, disposable medical device provided non-sterile. The Surgical Isolation Gown is constructed of the neck tie, the waist belt, and elastic cuffs. The body fabric material is Polypropylene SMS non-woven, coated with Polyethylene. And all seams are reinforced by sealing tape of 100% Polyurethanes. The Surgical Isolation Gown is offered in blue with seven sizes ( S, M, L, XL, XXL, 3XL, 4XL). The Surgical Isolation Gown has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3 requirement.

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 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 Surgical Masks are single use, three-layer, flat-pleated masks with ear loops and nose clip. Two layers of polypropylene non-woven fabric, with a layer of polypropylene melt-blown filter cloth in the middle; plastic nose clip, ear loop is spandex elastic belt. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The elastic ear loops are not made with natural rubber latex. The nose clip in the layers of mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire. The surgical masks will be provided in blue. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.