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SURGICAL FACE MASK with Earloop, 17.5×9.5cm – 3 PLY

The product is mainly composed of multi-layer non-woven fabric: the outer layer and the oral layer is PP spun bond non-woven fabric, and the middle is high filtration performance melt-blown non-woven fabric. The outer layer is available in blue, green, white, black and other colors; The ear straps are round and soft. The nose bridge strip is made of plastic materials and fits the nose bridge.
Availability:

The SURGICAL FACE MASK with earloop, 17.5×9.5cm – 3 PLY represents an essential protective barrier designed for rigorous clinical and medical environments. Manufactured within a certified 100,000-class cleanroom facility under a strict ISO 13485 quality management system, every single unit maintains exceptional medical-grade purity and structural consistency. The product is mainly composed of multi-layer non-woven fabric: the outer layer and the oral layer utilize PP spun bond non-woven fabric for structural integrity and skin comfort, while the middle layer features high filtration performance melt-blown non-woven fabric to effectively trap airborne particulates and fluids.

Visually and tactilely, the mask is engineered for extended daily wear. The outer fluid-resistant layer is available in blue, green, white, black, and other custom colors to suit different institutional protocols. The ear straps are round, exceptionally soft, and designed to minimize pressure points behind the ears during long shifts. Furthermore, the nose bridge strip is made of durable plastic materials over an aluminum core, allowing it to closely fit the natural contours of the wearer's face and prevent visual obstruction or fogging.

Product Description:

Engineered to meet stringent international medical standards, this protective facial covering delivers reliable defense against fluid penetration and particulate exposure. The advanced three-tier construction provides a dual-action filtration mechanism, ensuring both Bacterial Filtration Efficiency (BFE) and Particle Filtration Efficiency (PFE) perform exceptionally well under clinical stress. Each layer is ultrasonically bonded to prevent delamination, ensuring the mask maintains its protective profile even in demanding environments.

Product Name

SURICAL FACE MASK with earloop, 17.5×9.5cm – 3 PLY

Standard

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

Type IIR

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

BFE ≥ 98%, DP < 40 Pa/cm2, Synthetic Blood Penetration ≥ 16KPa, Microbial Cleanliness ≤ 30 CFU/g

Components

PROTECTIVE LAYER:   Spunbond non-woven of polypropylene, white/blue, 25±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, 25±2g/m2

NOSE BRIDGE STRIP:   Plastic covered aluminum clip

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

The specific material weights, meticulously maintained at 25±2g/m², ensure an optimal balance between breathability and dense filtration. By adhering to the EN14683:2019 standards across Type I, Type II, and Type IIR categories, procurement managers can confidently match the exact protection level required for their specific healthcare settings.

Advantages:

Selecting the right protective equipment requires a focus on both user safety and long-term wearability. This mask integrates several critical design benefits to support medical professionals during demanding tasks:

  • Hypoallergenic Composition: 100% Latex-free & Fiberglass free, eliminating the risk of common occupational skin allergies and respiratory irritation.

  • Exceptional Breathability: Easy to Breathe Through, maintaining a low differential pressure to prevent heat buildup and fatigue during extended procedures.

  • Tactile Comfort: Soft, Odorless & Non-Irritating, Skin-friendly inner oral layer that feels gentle against the face, absorbing moisture without compromising the filtration barrier.

  • Durable Securement: Soft earloops with an advanced ultrasonic welding process, ensuring a pain-free and comfortable wearing experience. The earbands boast a high tensile strength (≥10N) to prevent snapping during rapid donning and doffing.

  • Regulatory Compliance: Achieve CE certificate (No. G2S 037967 0030 Rev. 01) and full EC Declaration of Conformity. Every shipment includes a product qualification certificate, ensuring smooth global customs clearance and immediate institutional deployment.

Supply Ability:

Production Capacity: 40 million pcs per month.

Backed by a fully automated manufacturing infrastructure, our production lines operate with precision and speed to fulfill large-scale institutional demands. This substantial monthly output guarantees a stable supply chain, mitigating the risk of inventory shortages during peak procurement seasons. Beyond standard production, comprehensive OEM and ODM customization services are available. Procurement teams can specify exact mask colors, request tailored inner and outer packaging designs, and incorporate custom brand logo printing to align with regional market preferences or specific hospital branding guidelines. This flexibility ensures that every large-volume order is delivered exactly to specification, with expedited lead times.

Usage:

It is intended to be worn by health professionals during surgery and during nursing to catch the bacteria shed in liquid droplets and aerosols from the wearer's mouth and nose.

In practical applications, this barrier is crucial in operating theaters, intensive care units, outpatient clinics, and dental practices. By securely covering the lower face, it significantly reduces the transmission risk of airborne pathogens between the care provider and the patient. The Type IIR variant, specifically, offers enhanced resistance against synthetic blood penetration, making it the optimal choice for trauma centers and complex surgical interventions where fluid splashing is a recognized hazard. Its reliable fit ensures that the protective seal remains intact even when the wearer is speaking or moving.

Specification:

Proper packaging is vital for maintaining the microbial cleanliness of the masks during transit and storage. The configurations below detail the precise dimensions for both sterile and non-sterile options, utilizing robust corrugated cartons designed to withstand the rigors of international freight. This organized packing density maximizes shipping container utilization while protecting the structural integrity of the nose bridges and ear loops.

Package Description

Package

Box Dimension

Carton Dimension

50 PCS/ Open bag/ Box,

60 Boxes/ Carton,

Non-sterile

Pcs

/Box

Box

/Carton

Length

/cm

Width

/cm

Height

/cm

Length

/cm

Width

/cm

Height

/cm

50

60

19

10

7

52

40

45

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

50

40

19

10

10

52

40

42

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

Instructions:

Strict adherence to proper donning procedures is essential to maximize the filtration efficacy and maintain the hygienic integrity of the product. Please follow these steps carefully:

  1. Clean your hands thoroughly with soap and water or an alcohol-based sanitizer before touching the mask to prevent cross-contamination.

  2. Hold the mask by the ear loops with the earloops' ultrasonic welding spots facing outward. Place a loop securely around each ear.

  3. Adjust the mask vertically to cover the mouth, nose, and chin fully, creating a continuous protective zone.

  4. Form the plastic-covered aluminum nose bridge strip firmly around the contours of the nose and cheek to close any gap, ensuring exhaled air passes through the filter medium rather than escaping from the top.

After use, remove the mask by handling only the ear loops and dispose of it immediately in a designated clinical waste receptacle. Do not reuse single-use items.

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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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