Product Description:

CSD Medical Face Masks are made of three layers of non-woven fabric and are intended for use by medical personnel in medical institutions during clinical treatment or examinations. They are also suitable for general public use at home.

Purpose:

For medical purposes, to prevent infection between patients and medical personnel, excluding those worn during surgical procedures.

Protective Effect: Meets CNS14774 Level 1 Medical Mask standards (bacterial filtration efficiency >95%).

Instructions for Use:

• After removing the mask, put it on directly, pulling the pleats up and down to completely cover the bridge of the nose and chin.

• Press the sides of the shaping metal strip down to fit the bridge of the nose, and adjust the straps to fit the entire face.

Precautions:

• Do not get this product wet or wash it, otherwise it will lose its filtering effect.

• This product is disposable. It is recommended to replace it immediately after it becomes soiled. Do not reuse it.

• This product is not sterilized.

China Surgical Dressings Center Co., Ltd.

The product underwent relevant testing and evaluation during the design and development verification stage. All test results met the specified acceptance criteria, as detailed below:

1. In Vitro Cytotoxicity Test (ISO 10993-5)

Acceptance Criteria: Non-cytotoxic.

Result: Passed.

2. Skin Sensitization Test (ISO 10993-10)

Acceptance Criteria: No skin sensitization reaction.

Result: Passed.

3. Skin Irritation Test (ISO 10993-23)

Acceptance Criteria: No skin irritation reaction.

Result: Passed.

4. Functional Tests

(1) Bacterial Filtration Efficiency (BFE) Test (CNS 14775)

Acceptance Criteria: ≥ 95%

Result: Passed.

(2) Differential Pressure Test (CNS 14777)

Acceptance Criteria: < 5 mmH₂O/cm²

Result: Passed.

5. Safety Tests

(1) Free Formaldehyde Test (CNS 15580-1)

Acceptance Criteria: ≤ 75 mg/kg

Result: Passed.

(2) Prohibited Azo Dyes Content Test (CNS 16113-1 and CNS 16113-3)

Acceptance Criteria: ≤ 30 mg/kg

Result: Passed.

(3) Migratable Fluorescent Substances Test (CNS 11820)

Acceptance Criteria: No migratory fluorescent substances detected.

Result: Passed.

6. Stability Tests

(1) Elastic Ear Loop Tensile Strength Test

Acceptance Criteria: > 0.3 kg

Result: Passed.

(2) Elastic Ear Loop Adhesion Test

Acceptance Criteria: No breakage.

Result: Passed.

(3) Appearance Inspection

Acceptance Criteria: Clean, free from damage, and no deterioration.

Result: Passed.

All test results met the specified standards and acceptance criteria.

The product has successfully passed relevant verification tests, including biocompatibility evaluations (cytotoxicity, skin irritation, and skin sensitization), alcohol concentration testing, and stability testing, to ensure product quality and stability.

For quality-related abnormal events, a CAPA (Corrective and Preventive Action) system has been implemented to address and prevent issues. Through systematic root cause analysis, the system is designed to both prevent the recurrence of identified problems and proactively mitigate potential risks, thereby ensuring process and product compliance.

Risk management analysis is conducted in accordance with ISO 14971 to evaluate hazards, potential risks associated with product use, and corresponding risk control measures. The scope of application covers all or part of the product life cycle, from design and development through end-of-life.

By collecting and reviewing customer complaint records, TFDA defective product and adverse event reports, product quality abnormality records, customer satisfaction surveys, and recall event data, root cause analysis is conducted and corrective actions are established to reduce the occurrence of product quality issues.