Single-use medical mask (blue ear loops)
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Product Introduction
- Product Description
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Specifications: Large, Medium, Small.
Model: A3, A4, A5, B3, B4, B5.
[Structure and Composition]
This product consists primarily of a mask body and mask straps, which are either sewn or formed by mechanical pressing. The mask body comprises at least three layers made of nonwoven fabric, meltblown fabric, or activated carbon fabric, while the mask straps are made of nonwoven fabric or elastic bands. The product is sterilized with ethylene oxide and is supplied sterile; alternatively, it may be offered non‑sterile.
[Scope of Application]
Suitable for use in routine healthcare settings, it covers the wearer’s mouth, nose, and chin, providing a barrier against contaminants exhaled or expelled from the oral and nasal cavities.
[Contraindications, Precautions, Warnings, and Cautions]
1. If the packaging is damaged, do not use under any circumstances.
2. The product is for single use and must be destroyed after use.
3. Sterile products are sterilized with ethylene oxide; non-sterile products are not subjected to sterilization.
4. The product has a shelf life of two years.
5. Product specifications, quantity, production date, or batch number are detailed on the certificate of conformity or the packaging bag.
6. Instruction Manual Revision Date: May 7, 2020.
[Explanation of the Graphics, Symbols, Abbreviations, and Other Elements Used on Medical Device Labels]
1. Instructions for Use 2. Sun Protection 3. Single-Use
4. Moisture-proof 5. Ethylene oxide sterilization 6. Handle with care
[Product Maintenance and Care Instructions, Special Storage Conditions and Methods]
Packaged products shall be stored in a well-ventilated indoor environment with a relative humidity not exceeding 80% and free from corrosive substances.
Frequently Asked Questions
What does Nanchang Xiangyi Medical Device Co., Ltd. do?
This is a company established in 2001, located in Lidu Town, Jinxian County, Nanchang, integrating… Research and development, production, sales An integrated medical device enterprise, primarily manufacturing Class I and Class II single-use medical consumables as well as select medical devices, it is classified as a manufacturer of medical consumables.
What are the company’s main products?
The product range includes medical masks, medical surgical masks, N95 respirators, medical gauze, cotton balls, cotton swabs, disposable gloves, delivery kits, surgical packs, surgical drapes, drape sheets, surgical gowns, vaginal dilators, irrigators, nebulizers, blood collection tubes, urinary catheterization kits, tongue depressors, infusion dressings, and other sterile consumables and nebulization devices.
What category of medical device manufacturing license does the company hold?
possessing Class I and Class II medical devices Manufacturing qualifications: All Class II medical devices are duly registered with the Jiangxi Provincial Medical Products Administration, while Class I devices have completed the required filing procedures.
What is the product sterilization method?
The vast majority of single-use sterile consumables are made using Ethylene oxide (EO) sterilization After sterilization, the product undergoes standard desorption to control ethylene oxide residues and meet national standards.
Is the product exported?
Supports foreign trade export operations, assists clients in preparing the required export documentation, and facilitates connections with overseas distributors and international traders.
Can you provide OEM services?
We support OEM manufacturing partnerships for medical devices and can discuss customized specifications, packaging, and branding. All products must comply with medical device regulations, and we will provide the relevant regulatory documentation.
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