Instructions for Use (English)

[Product Name]

Y-FLOW DSH Moisturizing Gel

[Model Name]

A22, A20, A17, B20, B30

[Product Description]

This product is a water-based lubricating gel containing Hyaluronic Acid and Hydroxyethyl Cellulose.

[Intended Purpose]

Lubricant intended for patient medical or diagnostic purposes, or for temporary application to the vaginal mucosa to reduce friction, facilitate the insertion of diagnostic or therapeutic devices, and help prevent injury.

[Applicable Medical Device Types]

Used together with vaginal dilators, speculums, sampling swabs, probes, and other devices applied in visual inspection, pelvic examination, or related clinical procedures.

[Intended Operators]

To be used by physicians or by other healthcare professionals under the instruction or supervision of a physician. The product may also be used by patients at home under the recommendation and instructions of a physician.

[Use environments]

Hospitals and clinics, including outpatient gynecology and obstetrics departments. (Home use under the recommendation and instructions of a physician.)

[Applicable Body Sites]

Vaginal canal and external genital area

[Procedure for Use]

1. Preparation before use

a. Check the product’s expiration date. Do not use if the expiration date has passed.

b. Check the packaging and product for any damage such as breakage or exposure of contents. Do not use if any damage is found.

c. Familiarize yourself with the instructions for use of the product.

2. Instructions for use

a. Tear open the upper part of the single-use individual package and take out the product.

b. Twist the cap lightly at a 45° angle to remove it.

c. Hold the outer tube with the thumb and middle finger, place the index finger lightly on the plunger, and insert the applicator into the vagina approximately 5–8 cm in a comfortable position to facilitate insertion.

d. Press the plunger gently in one motion to dispense the contents (gel).

e. Slowly withdraw the applicator.

3. Storage and handling after use

a. This product is a “single-use medical device” and must not be reused.

b. Even if unused, discard any product once it has been opened.

[Precautions for Use]

1. Warnings

a. Do not use in patients with known or suspected hypersensitivity to any of the ingredients contained in the gel formulation.

b. Do not freeze or expose to excessive heat.

c. If irritation or discomfort occurs, discontinue use and consult a physician.

d. Do not use this product together with other silicone-based products.

e. Note that this product is not a contraceptive or spermicide.

f. If pregnant, or in the presence of local inflammation or other abnormalities, consult a physician before use.

2. General Precautions

a. Keep out of reach of children.

b. Do not use if the packaging is damaged.

c. Do not use the product after the expiration date indicated on the package.

d. Products past their expiration date must be disposed of in accordance with disposal regulations.

3. Precautions for Applicarion

a. This product has a slippery formularion; wipe immediately if spilled.

b. This product may leave stains on fabrics.

[Contraindications]

a. Do not use if you have known or suspected hypersensitivity to any of the ingredients contained in this product.

b. Do not use during pregnancy without prior consultation with a physician.

c. Do not use in cases of local inflammation, infection, or other abnormalities of the vaginal area.

d. Do not use together with other silicone-based products.

[Storage Instructions]

1. Storage Conditions

– Avoid direct sunlight.

– Store at room temperature (1°C to 30°C).

– Keep in a dry, low-humidity environment.

2. Packaging Information

– Packaging Type: Pre-filled container packed in a box.

– Packaging Materials: Outer tube (PP), stopper (PP), suction (Silicone), seal (PE)

[Expiration Date]

24 months from the date of manufacture

[Manufacturer (Product Owner)]

DSH MEDICAL CO., LTD.

712, 713, 714, 1035, 18, Gwangseokcheongil,

[Manufacturer (Physical Manufacturer)]

DAEMYUNG COMPANY

29, Dokjeong-ro 273beon-gil, Jingeoneup,

Namyangju-si, Gyeonggi-do,

Republic of Korea

[Date of Documentation]

2026. 01