Why Is EN14683 Type IIR Disposable Surgical Face Mask The Top Choice For Clinical Surgery?

2026-06-22 - Leave me a message

Medical institutions across Europe and global clinics require high-standard splash-resistant surgical masks for surgical and invasive treatment scenarios. Ordinary medical masks lack fluid barrier performance, which brings infection risks for medical staff. KINGSTAR INC Type IIR Disposable Surgical Face Mask follows EN14683:2019 standard with BFE ≥98%, featuring three-layer non-woven structure and splash-proof performance.

Type IIR Disposable Surgical Face Mask

1. Basic Definition of Type IIR Disposable Surgical Face Mask

Type IIR Disposable Surgical Face Mask is the highest-grade disposable medical mask under EU EN14683 regulation. The letter "R" stands for splash resistance, which means the mask can block blood, body fluid and medical liquid splashes during surgery, different from ordinary Type I/II masks without fluid barrier function.

KINGSTAR INC produces standard flat earloop Type IIR masks sized 17.5cm×9.5cm. It adopts three-layer polypropylene non-woven composite material, bacterial filtration efficiency reaches over 98%, fully complying with EU MDR medical device rules, equipped complete CE, ISO13485 and SGS test reports to support customs clearance of European, Australian and American markets.


2. Complete Size & Packaging Parameter Table

All batch packing specifications for bulk wholesale orders are listed below:

Item Specific Parameter
Single Mask Size 17.5cm × 9.5cm
Inner Packing 10 pieces per small bag
Middle Box 5 small bags / 50pcs per box
Outer Carton 48 boxes per export carton
Single Box Dimension 19.5×10×8.5 cm
Carton Outer Size 41.5×40.5×53 cm
Full Carton Gross Weight 11.5 KG
Mask Structure 3-ply flat earloop disposable
Core Standard EN14683:2019 Type IIR
BFE Rate ≥98%


3. Three-Layer Material Structure Details

Every KINGSTAR Type IIR Disposable Surgical Face Mask uses dedicated medical non-woven raw materials without inferior recycled fabric:

1. Outer layer: Polypropylene spunbond non-woven fabric, blocks large liquid splashes and dust particles, with anti-splash property meeting ISO22609 test standard

2. Middle filter layer: High-density polypropylene melt-blown cloth, the core filter layer to intercept bacteria and fine aerosol particles, stable filtration efficiency in long-time wearing

3. Inner skin-friendly layer: Soft spunbond non-woven fabric, reduce skin irritation for long-shift medical staff

Auxiliary accessories:

• Nose clip: PE coated iron wire, freely bent to fit different nose shapes for tight sealing

• Ear loop: Nylon & polyurethane composite elastic band, no ear pain after long-time use


4. Main Clinical Application Scenarios

KINGSTAR Type IIR Disposable Surgical Face Mask fits all high-risk medical environments needing fluid isolation:

• Operating rooms for general surgery, orthopedics and dental treatment

• Outpatient invasive examination rooms, injection and dressing change areas

• Emergency departments with frequent blood and body fluid exposure

• Veterinary clinics and cosmetic surgery institutions

• Public health epidemic prevention and centralized isolation venues

• Pharmaceutical production clean workshops requiring bacterial isolation


5. Product Using & Storage Precautions

Wearing Rules

1. The side printed with nose clip should face outward when putting on

2. Only single disposable use, strictly forbidden to wash or reuse after taking off

3. Replace the mask immediately if it gets stained, damp, deformed or damaged

Storage Requirements

Store finished cartons in clean, dry, ventilated warehouse without corrosive gas; keep away open fire and flammable goods, avoid direct sunlight long-term exposure to prevent material aging.


6. KINGSTAR Production Strength

KINGSTAR INC is a professional medical PPE manufacturer focusing on antigen test kits and medical masks for many years, fully compliant with global medical device supervision standards:

1. Complete Certificates: EU Declaration of Conformity, CE MDR certificate, ISO13485 medical quality management system certification, SGS filtration test report

2. Market Layout: Products exported to EU, North America, Southeast Asia, supported by EU authorized representative to meet overseas registration demands

3. Production Background: The factory passed relevant medical product filing standards, stable mass production capacity to support large hospital bidding orders

4. Product Line: Cover Type IIR surgical masks, FFP2 protective masks and COVID-19 antigen self-test kits, one-stop medical PPE supply for global buyers


7. Full Pre-Sales & Bulk Order Service

Pre-Sales

1. Free product samples provided for quality verification before bulk purchase

2. Send complete certification documents (CE, test report, ISO certificate) upon request

3. Custom outer box printing and packaging design for brand OEM orders

In-Sales

1. Stable mass delivery schedule for hospital group procurement

2. Real-time production photos sent during mass manufacturing

3. Support FOB, CIF and other international trade terms

After-Sales

1. Full product quality inspection before shipment

2. Online technical support for customs document sorting

3. Quick reply for mask specification and standard consultation


8. Customer FAQ

Q1 What standard does KINGSTAR Type IIR Disposable Surgical Face Mask comply with?

A: It meets EN14683:2019 Type IIR medical mask standard, BFE ≥98%, with professional splash resistance test data.

Q2 Can these masks be used in operating rooms with blood splashes?

A:Yes, the outer non-woven layer has fluid barrier performance specially designed for surgical high-risk scenes.

Q3 Is OEM custom packaging available for hospital distributors?

A:We support custom box printing, brand logo and exclusive packing design for bulk orders.

Q4 What certificates can you provide for EU customs clearance?

A:We supply CE MDR declaration, ISO13485 certificate and SGS official filtration test report.

Q5 Is the mask ear loop comfortable for all-day medical work?

A:Adopt soft composite elastic bands, avoid tight pressure on ears after long hours of continuous wearing.

Q6 What is your MOQ for wholesale orders?

A:Small trial batches are acceptable, large hospital bidding orders can get competitive factory direct price.


Summary

As the necessary protective supply for clinical surgical environments, KINGSTAR INC Type IIR Disposable Surgical Face Mask reaches EU top medical mask standard with reliable splash resistance and stable bacterial filtration performance. Supported by complete international medical certifications, stable factory production and one-stop bulk supply service, it becomes reliable PPE procurement choice for global hospitals, medical distributors and public health suppliers. If you need sample testing, detailed quotation, full certification files or OEM packaging customization plans, please feel free to contact us. Our professional international sales team will respond within 24 hours and provide targeted medical mask supply solutions for your business.

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