Disposable FDA 510(k) Custom Printed Medical Mask EN 14683 Face Mask

Product Description

Disposable FDA 510K/En14683 Decorated Custom Medical Face Masks

Our disposable medical face mask is a single-use mask option for healthcare, medical supply and other professional applications. The mask can be supplied with standard or custom printing, allowing distributors and healthcare buyers to add their own logo, pattern or brand design.

Depending on the selected model, the mask can be supplied according to applicable EN 14683 requirements and with FDA 510(k) clearance information where the specific model has the corresponding FDA clearance.

Product Description

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

Multi-Layer Medical Mask Construction

The mask uses a multi-layer nonwoven structure with a filtration layer between the outer and inner layers.

A typical configuration includes spunbond nonwoven layers and a meltblown filtration layer, together with elastic ear loops and a flexible nose piece. The exact material composition and number of layers should be confirmed according to the selected model.

This type of construction is commonly used in disposable surgical and medical masks. FDA 510(k) summaries for specific cleared masks describe three-layer flat-pleated designs using nonwoven and meltblown materials.

Custom Printed Medical Face Mask

For distributors and private-label buyers, the main difference is often the printing.

The mask can be customized with:

• Company logo
• Brand name
• Repeating pattern
• Custom graphic
• Promotional design
• Private-label artwork

Artwork should be provided in an approved file format before production. Printing position, color and available printing methods depend on the mask material and selected construction.

EN 14683 and Regulatory Documentation

For buyers supplying medical markets, regulatory documentation is an important part of product selection.

Applicable models can be supplied according to EN 14683 requirements. Where the specific mask model has FDA 510(k) clearance, the relevant 510(k) information can be provided for verification.

The actual regulatory status, model number and test results should always correspond to the finished product being supplied. FDA identifies surgical masks as Class II devices under 21 CFR 878.4040 and provides a 510(k) pathway for these devices.

Performance Testing

Depending on the applicable model and market requirement, medical face mask testing may cover areas such as:

• Bacterial filtration efficiency
• Particulate filtration efficiency
• Differential pressure
• Resistance to synthetic blood penetration
• Flammability
• Biocompatibility of relevant patient-contact materials

These performance items are not automatically the same for every disposable face mask. Test values and claims should be based on the documentation for the actual product model. FDA's recognized standards for medical face masks include ASTM F2100 and related test methods for BFE and other performance characteristics.

Comfortable Earloop Design

The mask is available with elastic ear loops and a flexible nose clip for everyday wearing.

The nose clip helps the user adjust the upper edge of the mask around the nose. Earloop material and attachment can be specified according to the selected model.

Different sizes can also be discussed for adult and other user requirements.

 

Detailed Photos

 

Characteristics:

A. Conform to FDA 510K of the USA (NO: K101000)
B. Fluid splash resistance
C. Particle filtration efficiency (PFE) > 99%
D. Bacteria filtration efficiency (BFE) > 99%
E. Differential pressure (Delta-P) > 4.5 mm H2O/cm2
F. Class I none flammable
G. Biocompatile
H. Non- irritating
I. Glass fiber free and latex free
J. Adjustable nose piece for easy use
K. Non-sterile
L. For single use

Sample Policy:

Factory direct sale new breathing mask Protective masks general face mask
1. Sample according to your design drawing. Sampling time: 3-5days.
2. Design your own sample, then remake it.
3. Existing Samples Sampling time: 1day
4. Make mass production after your 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(mmH20/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

Description :

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 of faces. Perfect for men, women, adults.
Care: Protect ourself and our loved ones with this disposable face masks in various environments such as home, office, school, gardening, construction, and also the work places as other public areas to help protect from allergens, dust and germs.
One Time Use: All these disposable masks are not recommend washable or reusable but for one time use and recommend to replace by each 4 hours.