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CE-certified Medical Face Mask

CE-Certified Disposable Medical Face Mask with Superior Filtration & Comfort This 3-ply non-sterile medical mask features an ergonomic round-corner design for optimal fit, combining breathability with high filtration efficiency. Certified to EN14683:2019 (Type I/II) and YY/T 0969 standards, it utilizes a multi-layer PP non-woven construction for reliable protection. - 3-layer construction: Spunbond outer/oral layers + high-efficiency melt-blown filter (BFE ≥95-98%) - CE/YY-T certified | DP <40-49 Pa/cm² | Microbial cleanliness ≤30-100 CFU/g - Latex-free & fiberglass-free with soft 6mm ear loops and aluminum nose clip - Available in blue/green/white/black | Size: 17.5×9.5cm | Ultrasonic sealing
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Product Overview

DISPOSABLE MEDICAL FACE MASK (Soft Earloop, Round Corner), 17.5×9.5cm – 3 PLY, Non-sterile

Designed for extended wear in demanding clinical and care environments, this disposable medical face mask combines reliable filtration with exceptional physical comfort. The product is meticulously engineered in both feature and shape to provide a secure, gap-free fit around the facial contours. It is primarily composed of a multi-layer non-woven fabric architecture that balances fluid resistance with breathability. The outer protective layer and the inner oral layer utilize premium PP spunbond non-woven fabric, offering a smooth, non-irritating touch against the skin. Sandwiched in the middle is a high-density melt-blown non-woven fabric acting as the core filtration barrier. To accommodate various institutional uniform guidelines and visual identification needs, the outer layer is available in a selection of colors including blue, green, white, and black.


Product Description

Strictly adhering to international medical device directives, these masks are manufactured to meet exact regulatory requirements, ensuring consistent safety and performance. Every batch undergoes rigorous testing for bacterial filtration efficiency, breathing resistance, and microbial cleanliness to guarantee compliance with MDD 93/42/EEC and EN14683:2019 standards.

Product Name

DISPOSABLE MEDICAL FACE MASK (Soft Earloop, Round Corner), 17.5×9.5cm – 3 PLY, Non-sterile

Standard

YY/T 0969 - 2013

BFE ≥ 95%, DP < 49 Pa/cm2, Microbial Cleanliness ≤ 100 CFU/g, Color Fastness to Rubbing: Dry ≥ 4, Wet ≥ 4

Type I

MDD 93/42/EEC, EN14683:2019, Type I

BFE ≥ 95%, DP < 40 Pa/cm2, Microbial Cleanliness ≤ 30 CFU/g

Type II

MDD 93/42/EEC, EN14683:2019, Type II

BFE ≥ 98%, DP < 40 Pa/cm2, Microbial Cleanliness ≤ 30 CFU/g

Components

PROTECTIVE LAYER:   Spun lace non-woven of polypropylene,  45±2g/m2

FILTER LAYER:   High performance Melt-blown non-woven of polypropylene, white, 25±2g/m2

ORAL LAYER:   Spunbond non-woven of polypropylene, super soft, white, 20±2g/m2

NOSE BRIDGE STRIP:   Plastic covered aluminum clip

EAR BAND: 6mm width fluffy flat ear loop; Sealing Type: Ultrasonic


Key Advantages & Features

Our medical face masks are designed to address the specific challenges faced by healthcare professionals and industrial workers who require prolonged respiratory protection without compromising on physical comfort.

Ergonomic & Exquisite Shape Design

Engineered to fit better with an exquisite shape design, the round corners prevent the edges from poking or irritating the delicate skin around the eyes and cheeks, ensuring a contoured, secure seal.

Hypoallergenic Material Composition

Completely latex-free & fiberglass free, these masks eliminate common allergens. The inner oral layer is exceptionally soft, odorless & non-irritating, providing a skin-friendly surface that reduces friction and moisture build-up during extended shifts.

Optimized Breathability

Despite the dense filtration layers, the material structure makes it easy to breathe through. The controlled differential pressure (DP) ensures that users can maintain normal breathing patterns without excessive heat accumulation.

Enhanced Earloop Comfort

Equipped with 6mm soft earloops attached via an advanced ultrasonic welding process, the design distributes tension evenly. This results in a pain-free and comfortable wearing experience, preventing the common issue of behind-the-ear soreness.

Certified Compliance & Customization

We proudly achieve CE certificate (No. G2S 037967 0030 Rev. 01), providing full documentation for seamless market entry. Additionally, we support extensive OEM customization, allowing medical institutions to tailor colors and packaging formats to their specific operational requirements.


Production Capacity & Supply Chain

Supply Ability: 40 million pcs per month

Operating a highly efficient, automated manufacturing facility allows us to maintain a robust and scalable supply chain. With a monthly output capacity reaching 40 million pieces, we are fully equipped to fulfill large-scale procurement demands with consistent lead times. Our production lines are adaptable, supporting both sterile and non-sterile packaging configurations to serve diverse clinical, surgical, and general care environments. Stringent internal quality controls ensure that every shipment, regardless of volume, adheres strictly to the declared microbial cleanliness and filtration standards, providing our partners with absolute reliability and peace of mind.


Packaging Specifications

To preserve the integrity and hygiene of the medical face masks during transit and storage, we utilize standardized, durable packaging materials. The dimensions and quantities are optimized for efficient palletizing, inventory management, and space utilization in medical supply rooms. Below are the detailed metrics for our various packaging options.

Package Description

Package

Box Dimension

Carton Dimension

50 PCS/ Open bag/ Box,

40 Boxes/ Carton,

Non-sterile

Pcs

/Box

Box

/Carton

Length

/cm

Width

/cm

Height

/cm

Length

/cm

Width

/cm

Height

/cm

30

50

20.5

10

7.5

52

43

40

Single piece/ Bag,

50 Bags/ Box,

40 Boxes/ Carton,

Non-sterile

Pcs

/Box

Box

/Carton

Length

/cm

Width

/cm

Height

/cm

Length

/cm

Width

/cm

Height

/cm

40

50

21

10

9

52

44

47

Single piece/ Paper-Paper bag,

50 Bags/ Box,

12 Boxes/ Carton,

Sterile

Pcs

/Box

Box

/Carton

Length

/cm

Width

/cm

Height

/cm

Length

/cm

Width

/cm

Height

/cm

50

12

23

13

10

47

40

41


Usage Instructions

Proper application is critical to achieving the stated filtration efficiency and protecting the respiratory tract. Please follow these standardized steps for safe donning and adjustment:

1. Clean your hands with soap and water sanitizer before touching the mask to prevent contamination of the inner layer.

2. Hold the mask by the ear loops with the earloops welding spots outward. Place a loop around each ear, ensuring the colored fluid-resistant layer faces the external environment.

3. Adjust the mask to cover the mouth and nose fully. Pull the bottom edge gently under your chin to create a maximum protective area.

4. Form the nose bridge strip around the nose and cheek to close any gasp. Use both index fingers to mold the plastic-covered aluminum clip securely against your nasal contours, minimizing air leakage and preventing eyewear fogging.


Frequently Asked Questions

What documentation is provided for customs clearance and regulatory compliance?

We supply a comprehensive suite of compliance documents, including the official CE certificate (No. G2S 037967 0030 Rev. 01), Declaration of Conformity (DoC), and detailed test reports confirming adherence to EN14683 Type I/II and MDD 93/42/EEC standards. This ensures smooth customs processing and immediate market readiness.

Can we request physical samples before committing to a large volume order?

Yes, we actively encourage prospective buyers to evaluate our products firsthand. We can dispatch sample packs featuring different color options and packaging styles (sterile vs. non-sterile) so your quality assurance team can verify the material softness, earloop weld strength, and overall construction.

How do you manage lead times for customized packaging orders?

With a stable production capacity of 40 million pieces per month, standard orders are processed rapidly. For OEM requests involving custom box printing or specific bagging configurations, the lead time typically requires a brief extension to accommodate printing plate preparation. We maintain transparent communication throughout the production cycle to align with your inventory schedules.

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Kingstar Medical Products Co., Ltd. was founded in 1999, and we are a professional medical products enterprise.

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Phone: +86 15027331116
Email: sales@hbkingstar.com;
            tracychen@hbkingstar.com
Add: 2 Wenwei Rd., Zhanggou Town, Xiantao City, Hubei Province, China

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