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Surgical mask (with different trade names: Face Mask, Surgical Mask, Surgical Face Mask) is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates.

Surgical Mask is single use multi-layer mask with outer layer and inner layer (spunbond polypropylene) that sandwich a meltblown polypropylene filter material. There are 2 options for the surgical mask to be secured on user - via earloops or ties. Earloops are of urethane elastic fiber and latex-free; and ties are of spunbond polypropylene and also latex-free. The nose piece is a pliable white aluminum strip, covered by PP covering. All of the materials used in the construction of the Surgical Mask are being used in currently marketed devices.

Insulin pen needle is intended for use with pen injector for subcutaneous injection of insulin.

Insulin pen needle is a single-use device, which consists of needle tube, needle shield, needle seat, needle seat protection cover, and seat seal paper. Needle gauge includes 29G, 30G, 31G, and 32G. Needle length can be produced to various sizes. After sterilization by EO, it's sterile, pyrogen free, and non-toxic. Its shelf life is 5-year.

The Syringe with or without needle is intended for dispensing/administering fluids, and collecting/ sampling of fluid in medical practice. The insulin syringe (U-100) with fixed needle is a device intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of U-100 insulin into parts of the body below the surface skin. The Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

| Device Name | Intended Use | Nozzel | Nominal Capacity / Gauge | Material | Remark | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|----------------------------------------------------------------------|------------------------------|------------------------| | Syringe | Syringe is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. | Luer Slip | 1ml、2ml、3ml、5ml、10ml、20ml、30ml、50ml | PP/PE | With or Without Needle | | Insulin Syringe | Insulin syringe (U-100) with fixed needle is a device intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of U-100 insulin into parts of the body below the surface skin. | Fixed | 0.3ml、0.5ml、1ml | PP/PE | With Fixed Needle | | Hypodermic Needle | Hypodermic Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. | Female 6% Luer Conical Socket | 16G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G | SUS 304 Stainless Steel / PP | - |

The Tiger SFM0001 surgical mask is intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

The Tiger surgical mask SFM0001 (colors: blue) is flat pleated by 3-ply masks with outer layer and inner layers (spunbonded polypropylene) that sanwich a meltbown polypropylene filter material; Ear-loops are made of urethane elastic fiber for free elastic loops. The nose piece is white aluminum strip with PP covering. All of the materials used in the construction of the Tiger flat surgical Masks are being used in currently marketed devices (see predicate information). All items are nosterilize and only for single use.

The indication for use for all the product variants is grouped into three different sections: (a) Uncuffed, oral/nasal and Cuffed, oral /nasal: The intended use of this device is to be intubated into a patient's trachea via the nose or mouth for airway management. (b) Uncuffed, nasal only and Cuffed, nasal only: The intended use of this device is to be intubated into a patient's trachea via the nose for airway management, specifically for use in surgical procedures involving the head, neck and face. (c) Uncuffed, oral only and Cuffed, oral only: The intended use of this device is to be intubated into a patient's trachea via the mouth for airway management, specifically for use in surgical procedures involving the head, neck and face.

Tiger Medical Products Ltd's Endotracheal tube is available in 90 different variants distributed among 6 main configurations and different sizes, as detailed below. It is marketed as sterile, single use, for airway management. It consists of a clear tracheal tube with radiopaque blue stripe running its entire length, and it is graduated with multiple centimeter markings to allow easy detemination of intubated length, and is terminated with a 15mm standard connector. It conforms to ISO 5261: 1999 and ASTM F1242: 1996 with one minor exception in the tube marking. The six categories (or confiqurations) are listed below: - (a) CATEGORY 1: uncuffed, oral/nasal: It is provided as uncuffed, murphy, oral/nasal, and in 0.5mm ID increments from sizes 2.0 to 10.0 inclusive, totalling 17 sizes - (b) CATEGORY 2: uncuffed, nasal only: It is provided as uncuffed, murphy, preformed nasal- 2 eyes, and in 0.5mm ID increments from sizes 2.0 to 10.0 inclusive, totalling 17 sizes - (c) CATEGORY 3: uncuffed, oral only: It is provided as uncuffed, murphy, preformed oral- 2 eyes, and it is provided as anones from sizes 2.0 to 10.0 inclusive, totalling 17 sizes - (d) CATEGORY 4: cuffed, oral/nasal: lt is provided as cuffed, murphy, oral/nasal, and in 0.5mm ID it is provided as sizes 4.0 to 10.0 inclusive, totalling 13 sizes - (e) CATEGORY 5: cuffed, nasal only: It is provided as cuffed, murphy, preformed nasal, and in 0.5mm ID increments from sizes 4.0 to 10.0 inclusive, totalling 13 sizes - (f) CATEGORY 6: cuffed, oral only: lt is provided as cuffed, murphy, preformed oral, and in 0.5mm ID increments from sizes 4.0 to 10.0 inclusive, totalling 13 sizes