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The Procedure mask/Surgical mask/Face mask is 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, provided non-sterile.

The subject device is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The subject device is available in one type, ear loop. The ear loops are made of polyester and spandex. The ear loops model is held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The nose clip is made of Iron and polypropylene. Users can adjust the nose clip 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 ear loop masks are available in two size, 17.5 × 9.5 cm and 14.5 × 9.5 cm. And the colors for the ear loop mask are yellow, blue and white. The ear loop masks are available in level 1, level 2 and level 3 masks based on ASTM F2100-23. This is a single-use, disposable device, provided non-sterile.

For Prescription Use: Under the supervision of a healthcare professional, Antibacterial Gel Wound Dressing is indicated for the management of first and superficial second degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites. For Over-the-Counter Use: Antibacterial Gel Wound Dressing is intended for the management of minor abrasions, cuts, lacerations and scalds.

The subject device, Antibacterial Gel Wound Dressing, is a non-sterile, repeated-use moist amorphous gel. The hydrogel consists of amorphous cellulose-based gel complex, silver ions and Benzalkonium Chloride (BZK). The silver ions and Benzalkonium Chloride (BZK) act as a preservative to inhibit the growth of microorganisms in the gel during shelf storage. The hydroxyethyl cellulose is used as thickener to modify the viscosity of the wound gel, resulting in a moist amorphous gel with the function of moisture donation and moisture absorption. The combination of allantoin and propylene glycol are used as moisturizer to prevent gel water release. The gel possesses both moisture donating and moisture sequestering action depending on the moisture level in the wound. The hydrogel helps to maintain a moist wound environment. The hydrogel is supplied in collapsible blind ended heat sealed HDPE tubes fitted with screw caps.

Prescription Use: Skin and Wound Cleanser for prescription use is intended for use under the supervision of healthcare professionals for cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. OTC Use: Skin and Wound Cleanser for over-the-counter use is intended for cleansing wounds and moistening absorbent wound dressings for the management of minor cuts, minor abrasions, minor lacerations and minor burns.

The proposed devices, Skin and Wound Cleanser, is a clear, colorless solution that is intended for wound management including cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings (e.g. gauze).The solution of Skin and Wound Cleanser contains purified water, PHMB, undecylenamidopropyl betaine, and trace ingredients (allantoin, citric acid). During the application of product, fluid moving across the wound aids in the removal of foreign objects such as dirt and debris. Skin and Wound Cleanser solution contains PHMB, a known antimicrobial preservative, which is shown to inhibit the growth of microorganisms such as Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Aspergillus niger, Methicillinresistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterocccus faecalis (VRE) to maintain quality of the product during storage of the wound cleansing solution.

The Collagen Wound Dressing is indicated for the management of exuding wounds including: Full thickness and partial thickness wounds Pressure and venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers Partial thickness burns Donor sites and other bleeding surface wounds Abrasions Traumatic wound healing by secondary intention Dehisced surgical incisions

Collagen Wound Dressing is an advanced wound care device composed of pure freezedried cross-linked bovine collagen. It is a sterile, absorbent, white, porous, topical wound dressing. As a primary wound dressing, it can be cut to any size or be used in multi-layers to fit wound. It can also be used in combination with either occlusive or semi-occlusive secondary dressing. The product is biodegradable.

Antibacterial bandage is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns.

The subject device. Antibacterial bandage, is to be applied topically to the skin for the management of minor cuts, minor scrapes and minor burns. The subject devices are available sterile in three models. All of devices contain three layers: (1) adhesive backing layer (fabric or plastic); (2) exactly same antibacterial non-stick absorbent pad layer (composed of Polyester fiber, viscose fiber, PE mesh, Benzalkonium chloride); (3) release liner. Each model is available in different sizes with identical materials, chemicals and physical properties, therefore, size of the device will not affect the function and performance of products. All models of subject device, Antibacterial bandage, are for single use only and sterilized by Ethylene Oxide using conditions validated following ISO 11135:2014.

The Procedure mask/Surgical mask is 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, provided non-sterile.

The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are used to secure the mask over the users' mouth and face. The nose clip is made of Iron and polypropylene. Users can adjust the nose piece according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5×9.5 cm and 14.5×9 cm; the tie-on mask is available in one size, 17.5×9.5 cm. And the colors for the ear loop mask are blue and black; the color for the tie-on mask is blue. Both the ear loop and tie-on masks are available in level 3 masks based on ASTM F2100-19 due to the difference in gram weight of the mask body. The proposed device is provided in non-sterile.

Prescription Use: PHMB Wound Dressings are indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, first and superficial second degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds. OTC Use: For Over-the-Counter Use, PHMB Wound Dressing is used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns.

The proposed device PHMB Wound Dressing is a sterile wound dressing. It is used as a primary or secondary dressing to absorb wound exudates. Based on in vitro testing, the antibacterial agent PHMB in dressing helps to resist bacterial colonization within the dressing for up to 7 days. The proposed device is available in two configurations, The first one, PHMB Island Wound Dressing with acrylic adhesive, consists of a polyester viscose non-woven backing layer coated with acrylic adhesive as the top layer, a center soft absorbent pad which is made of non-woven fabric containing 0.2 % PHMB and it is laminated with the PET film, and a release liner covers on the top adhesive layer border part. The second one, PHMB Pad Wound Dressing, only consists of a soft absorbent pad containing 0.2 % PHMB and the non-woven absorbent pad is laminated with the PET film.

The Silicone Ag Foam Dressing (OTC) /Silicone Ag Foam Dressing with Border (OTC)/ Ag Foam Dressing Non-adhesive (OTC) and Ag Foam Dressing Adhesive (OTC) are indicated to cover and protect, absorb wound exudate, and maintain moisture balance of minor cuts, minor abrasions, minor lacerations, and minor burns.

It is a sterile, single-use dressing, the foam layer contain about 0.25-0.35mg/cm2 silver. The dressing absorbs wound exudate and releases silver ions within the dressing in the presence of wound fluid to help reduce bacterial colonization of the dressing. It also assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The devices are available in four configurations: Ag Foam Dressing Non-adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, and Silicone Ag Foam dressing with Border. The dressing has light yellow or light brown appearance and is available in the form of pad and in different sizes packaged in pouches. All dressings can absorb exudates, maintains a moist wound healing environment and has good antibacterial properties. It has been shown that antibacterial effectiveness within the dressing for up to 7 days, as demonstrated in vitro.

Antimicrobial gauze sponge dressing, antimicrobial super sponge dressing, and antimicrobial non-woven sponge dressing are indicated to cover and protect, absorb wound exudate, and maintain moisture balance of minor abrasions, minor lacerations, and minor burns.

The devices are available in three configurations, which are Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing and Antimicrobial non-woven sponge dressing. All of them consist of (1) a dressing (base material) and (2) anti-microbial agent. For each configuration, it is available in several models, which are different in size and quantity of anti-microbial agent. Based on in vitro testing, the product can achieve board spectrum antimicrobial effect within the dressing for Gram+ and Gram- Bacteria and Fungi. It has been shown to have 4 log bacterial reduction in vitro against the following test organisms: Staphylococcus aureus (ATCC 6538), Escherlchia coli (ATCC 25922), Candida albicans (ATCC 10231), Pseudomona aeruginosa (ATCC 9027) and Bacillus subtilis (ATCC 6633), Streptococcus pyogenes (ATCC 19615), Serratia marcescens (ATCC 31026), Aspergillus niger (ATCC 16404). The effective inhibition of bacteria is 7 days.

Prescription Use: Under the supervision of a healthcare professional. Extra Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as follow: Partial thickness (second degree) burns; Pressure ulcers (partial and full thickness); Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology); Diabetic foot ulcers; Surgical wounds that heal by primary intent such as dermatological and surgical incisions; Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites; Traumatic wounds. OTC Use: Extra Silver Gelling Fiber Dressing may be used for the management of: Minor Abrasions, Minor Lacerations, Minor cuts, Minor scalds and burns.

Extra Silver Gelling Fiber Dressing is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose (CMC) fibers, strengthening fibers and 1.2% ionic silver. This dressing absorbs wound fluid and creates a soft gel that conforms to the wound surface, maintains a moist environment. A moist wound environment supports the body's healing process. The silver antimicrobial may help reduce bacterial colonization within the dressing for up to 7 days. The dressings are supplied sterile in a range of sizes, ranging in area from 25cm2 to 600cm². All dressings have the exactly the same material, chemical, and physical properties and are different only in size. All dressings are sterilized and sold after sterilization by gamma radiation using conditions validated following ISO 11137-2:2013.