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Disposable FDA 510K En14683 Decorated Custom Printed Medical Face Mask

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Product Description

Basic Info
Ethylene Oxide Sterilization Without Ethylene Oxide Sterilization
Quality Guarantee Period Two Years
Group Adult & Child
Logo Printing With Logo Printing
Size Adult: 17.5*9.5cm / Child: 14.5*9.5cm
Layer 3ply
Style Earloop
Color White/Blue/Green/Yellow etc.
Nose Clip Single Nose Wire/Double Nose Wire/Plastic Nose Clip
Certificate CE, ISO 13485, FDA 510(K)
Sterile Nonsterile
Material Composition PP Non-Woven / Meltblown / Inner Layer
Filtration Efficiency Bfe >99%
Fluid Resistance 160 Mmhg Splash Resistance
Transport Package 50PCS/Box, 40boxs/CTN
Specification Adult: 17.5*9.5cm; Child: 14.5*9.5CM
HS Code 63079000
Production Capacity 9,000,000 PCS/Month
Product Description
Disposable FDA 510K/En14683 Decorated Custom Medical Face Masks
Technical Parameter Detailed Specification & Commercial Standard
Product Classification Disposable Decorated Medical Face Mask (Non-Sterile / Sterile Optional)
Layer Architecture 3-Ply Structure (Outer Spunbond + Middle Meltblown Filter + Inner Skin-friendly Layer)
Bacterial Filtration (BFE) >99% Sub-micron Particle and Pathogen Barrier Efficiency
Fluid Resistance Level Meets Type IIR / Level 3 Standards (Resists synthetic blood splashes at 160 mmHg)
Differential Pressure <60 Pa/cm3 (Delivers superior cool breathability for extended wear)
Microbial Cleanliness <30 cfu/g (Processed under strict dust-free medical manufacturing environments)
Printing Ink Standard Hypoallergenic, Odorless, Food-Grade Water-Based Ink (Skin Irritation Passed)
Dimension Specs Standard Adult Size: 17.5 cm x 9.5 cm (Custom sizing available for pediatric ranges)
Earloop Design Ultra-soft, highly elastic flat earloops (Latex-free to prevent ear fatigue)
Nose Clip Type Fully adjustable, integrated plastic-coated aluminum dual wire nose bridge
Wholesale Packing 50 Pcs per Customized Color Retail Box / 2,000 Pcs per Master Export Carton
Factory Certifications ISO13485 Quality System, CE EN14683 Compliant, FDA 510K Registered Facility
B2B OEM Capabilities Full Surface Patterns, Private Logo Placement, Custom Colorways, Private Label Boxes
Characteristics:
Conform to FDA 510K of the USA (NO: K101000)
Fluid splash resistance
Particle filtration efficiency (PFE) > 99%
Bacteria filtration efficiency (BFE) > 99%
Differential pressure (Delta-P) > 4.5 mm H2O/cm2
Class I non-flammable
Biocompatible
Non-irritating
Glass fiber free and latex free
Adjustable nose piece for easy use
Non-sterile
For single use
Sample Policy

1. Sample according to your design drawing. Sampling time: 3-5 days.

2. Design your own sample, then remake it.

3. Existing Samples Sampling time: 1 day.

4. Make mass production after you confirm the sample.

Quality Control

1. We will not start to make the products until you confirm the sample.

2. The packing will be water-proof, damp-proof and sealed.

Our Advantage

1. CE, ISO13485 certification.

2. One-stop service: Excellent disposable medical products, personal protection equipments.

3. Welcome any OEM requirements.

4. Qualified products, 100% new brand material, safe and sanitary.

5. Offered free samples.

6. Professional shipping service if necessary.

7. Full series after sales service system.

Standard Class Bacterial Filtration Efficiency (BFE) Breathing Resistance (mmH2O/cm2) Splash Resistance (mmHg)
Type I >98% <3.0 N/A
Type IR >98% <5.0 120
Type II >99% <3.0 N/A
Type IIR >99% <5.0 120
Keep Safe

These Face masks are class 1 medical devices, and can be used for healthcare use, but should not be used in surgical or high risk situations, or where there is a high risk of contact with liquids or infectious materials.

Comfort & Breathable

Made with non-woven fabric for effective airway protection from small particles and droplets. Soft, non-irritating, comfortable and breathable. Adjustable earloop and nose clip fits for most faces. Perfect for men, women, adults.

Care

Protect yourself and your loved ones with these disposable face masks in various environments such as home, office, school, gardening, construction, and also workplaces as other public areas to help protect from allergens, dust and germs.

One Time Use

All these disposable masks are not recommended washable or reusable but for one time use and recommended to replace each 4 hours.

Detailed Photos
Frequently Asked Questions
Q1: What certifications do these decorated medical face masks have?
Our face masks are processed under a registered facility with CE, ISO 13485, and US FDA 510K certifications, ensuring international quality standards.
Q2: What is the filtration efficiency of these disposable face masks?
These masks offer a high level of protection, with a bacterial filtration efficiency (BFE) > 99% and a particle filtration efficiency (PFE) > 99%.
Q3: How many layers do these masks have and what are they made of?
They feature a 3-Ply structure composed of a PP non-woven spunbond outer layer, a middle meltblown filter layer, and an inner skin-friendly layer for comfort and breathability.
Q4: Are these decorated medical masks reusable?
No, these are single-use disposable masks. It is recommended to replace the mask every 4 hours to maintain optimal performance and hygiene.
Q5: Are the printing inks safe for sensitive skin?
Yes, we use food-grade, odorless, water-based printing inks that are hypoallergenic and have passed strict skin irritation tests.
Q6: What customization options are available for wholesale orders?
We offer full surface OEM patterns, customized colorways, private logo placement, customized pediatric sizes, and custom-branded retail boxes.

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