DrSharpe Health DrSharpe Health

FDA/En14683 Certificated Disposable Medical Use Face Mask with Earloop 3ply Disposable Hospital Use Surgical Face Mask

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Product Description

Basic Information

Model NO.A-31
Available TimesDisposable
TypeMedical Surgical Mask
Layers3 Ply
StyleEarloop
ShapeFlat
SterilizationNon Sterilization
Age GroupAdult
ColorBlue
Item NameDisposable Medical Face Mask
Art No.a-31
MaterialPP + Meltblown + PP
Certificates510K/ISO13485/ISO9001/EN14683/CE MDR/UKCA
SampleFree Sample
ApplicationHospital, Pharmacy, Laboratory
Shipping PortsWuhan, Shanghai, Guangzhou
Transport Package50PCS/Box, 40boxes/Case
Specification17.5x9.5cm
TrademarkODM or OEM
Production Capacity50 Container/Month

Product Description

Earloop Face Mask: Made of soft non-woven material, featuring a 3-ply protective design. Non-irritating and highly protective, utilizing professional materials, strict production processes, and expert workmanship to ensure reliability and safety. Excellent filtration for bacteria and particles, ideal for hospitals, laboratories, and clinics. Features double elastic latex-free earloops for a comfortable, flexible wearing experience.

Disposable Medical Use Face Mask with Earloop
Disposable Hospital Use Surgical Face Mask
Product Name Level-3 Surgical Face Mask
Art No. A-31
Material Polypropylene + Meltblown + Polypropylene
Layer 3-ply
Model With earloop (latex-free elastic rubber)
Size 17.5x9.5cm, or customized
Color White, Green, Blue
Certificates CE MDR / ISO13485 / ISO9001 / EN14683 / FDA 510K / UKCA
Brand OEM Available
Type Single use, non-sterile

Product Features

  • 3-Ply Protective Design: Built with Polypropylene + Meltblown + Polypropylene for professional and reliable filtration safety.
  • Latex-Free Earloops: Skin-friendly elastic loops that prevent irritation and minimize tightness during extended wear.
  • Waterproof & Breathable: Effectively blocks droplets while maintaining comfortable ventilation.
  • High Filtration Efficiency: Excellent bacterial and particle filtration for critical settings.
  • Adjustable Nose Bridge: Enhances fitment to prevent air leakage and conforms comfortably to the face.
  • Lightweight & Compact: Space-saving thickness, convenient to carry and store.

Packaging & Shipping

Packing 50pcs/box, 40boxes/case (adjustable according to requirements)
MOQ 50 cases
Availability 50 Forty-Foot Container / Month
Ports Wuhan, Shanghai, Guangzhou, etc.
Payment L/C, D/A, D/P, T/T, Western Union, MoneyGram
Delivery Time 2-3 weeks (negotiable)

Certifications

We have obtained ISO9001 and ISO13485 quality management system certifications, Class I and II licenses for medical devices, Sedex international social responsibility certification, and US FDA, CE, and Nelson testing certificates. Additionally, our products comply with the European standard EN14683 medical mask requirements, US FDA 510K Medical Mask (Level-3) specifications, European standard CAT3 Type 4/5/6 industrial protective clothing regulations, and EN14126 Type 4B/5B/6B medical protective standards.

Medical Face Mask Certifications

Use Instructions

  1. Hold the mask vertically with the metallic nose clip bar facing upwards.
  2. Place the mask tightly against the face, aligning the nose clip bar with the bridge of your nose.
  3. Loop the elastic bands around both ears, adjusting the alignment flat against the skin.
  4. Press and adjust the nose clip bar to fit the contour of your nose bridge.
  5. Conduct a fit test: Cover the mask with both hands to check for air leakage. If air escapes from the top, adjust the nose clip. If air leaks from the sides, adjust the earloops for a snugger fit.
Face Mask Wearing Instructions

Company Profile

We mainly specialize in healthcare products, providing a wide range of disposable items for safety and hygiene sectors, hospitals, food services, laboratories, electronic assembly lines, and cleanrooms. Supported by 20 years of regional manufacturing expertise and state-of-the-art machinery, we maintain strict management workflows from raw material intake to post-production testing. Our capabilities allow us to manage large volumes, duplicate customer package specifications, and develop customized configurations tailored to unique brand requirements.

Manufacturing Cleanroom Production
Quality Management System Inspection

Exhibitions

We have participated in numerous international trade fairs, accumulating valuable market insight and establishing long-term customer relationships globally. Notable events include presentations and trade shows in Arab (2014), Dubai (2016), Iran & Thailand (2017), Japan (2018), Germany & Korea (2019), and Germany (2024).

Exhibition Booth Presentation
Trade Fair Interaction
Medical Expo Event
Global Trade Show Stand
International Health Exhibition
Product Display Showcase

Frequently Asked Questions

Q1How to make an inquiry?
Please provide details regarding the materials, sizes, and quantities of the products you require, alongside your preferred shipping method. We accommodate first-time orders and welcome drawings or specifications of items you need. You may contact us via email to outline your expectations.
Q2Can we design the packaging with our own logo?
Yes. We can design and produce customized outer packaging aligned with your specifications, including custom cartoon styles, board thickness, print colors, and branding details.
Q3How are product samples handled?
Once pricing terms are established, we supply complimentary samples to evaluate product specifications and build quality. Mass production begins following your formal approval of the sample.
Q4What certifications are available?
Our manufacturing lines are backed by ISO13485 and ISO9001 quality management systems. The masks comply with CE MDR requirements and hold Type 5/6 classifications.
Q5What are your primary product categories?
Our core product categories include disposable face masks, isolation gowns, coveralls, laboratory coats, surgical drapes, mob caps, protective aprons, boot covers, and disposable gloves.
Q6What are the standard payment terms?
We accept T/T (and secure online options for sample/minor setups) alongside L/C at sight. For established high-volume buyers, we can discuss credit extension configurations, document presentations (D/P), or alternative payment paths.

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