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CE ISO Certified PVC Disposable Oxygen Mask
Negotiable
3,000 Pieces
Sample price:US$1.00/piece.Request sample

Product profile

Customization

Available

Type

Oxygen Mask

Material

Medcial Grade PVC

Model NO.

Oxygen Mask

Ethylene Oxide Sterilization

Ethylene Oxide Sterilization

Quality Guarantee Period

5 Years

Group

All

Logo Printing

Negotiable

Package

1PC/Bag, 100PCS/Carton

Usage

Hospital and Home

Single Use

Yes

Factory

Yes

Medical Classification

Class II

Registration Documents

Available

Certification

CE, ISO13485, FDA

Transport Package

Carton 48*36*27cm

Specification

S, M, L, XL

Trademark

MADEWELL or OEM

Origin

Zhejiang Jiaxing

HS Code

9020000000

Production Capacity

800000 PCS Per Moth

Key features

Medical Grade Material: Made of 100% medical grade PVC, non-toxic and latex free.
CE ISO FDA Certified: Class II medical device with CE, ISO13485, and FDA certifications.
Customizable Tube Length: Tube length can be customized to meet specific requirements.
Comfortable Design: Features adjustable nose clip and ribbed tube to prevent twisting.
Universal Connector: Transparent tube equipped with universal connector for compatibility.
Sterile Single Use: Ethylene oxide sterilized, designed for single use only.
Multiple Size Options: Available in S, M, L, and XL sizes for various needs.
OEM ODM Service: Full customization, minor customization, and flexible options available.

Company profile

Haiyan Kangyuan Medical Instrument Co., Ltd.
Importers and ExportersHigh Repeat Buyers ChoiceYears of Export ExperienceProduct Certification
CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 19 Years CertifiedNearest Port: Shanghai Port, Ningbo PortAverage Response Time: ≤10.03h

AI-Powered supplier vetting

SummaryThe supplier operates manufacturing facilities for molding, extrusion, and sterilization and is engaged in Class I medical-device and protective-equipment production. It supports extensive customization, ODM, and OEM services, with documented finished-product inspection instructions and stated quality assurance. Export experience is substantial, with 19 years of exporting and 71%–90% of sales from exports. However, the supplier reported no new products in the past year, no 3D software design, no ERP/OA/CRM/SAP digital integration, no inventory or overseas service infrastructure, and no valid manufacturing-capacity contract with related subcontractors. Corrective-action and complaint-handling procedures exist but lack written records. CE certification is stated, while management-system certification is listed only as “Others.”
Supplier typeThe supplier is a manufacturing-oriented enterprise with molding, extrusion, and sterilizing facilities, and its stated business scope includes production of Class I medical devices, masks, labor-protection equipment, and medical protective equipment. This indicates a direct manufacturer profile rather than a purely trading or service intermediary.
CertificationsThe supplier states that its products hold CE certification. Its management-system certification is recorded only as “Others,” without identifying a specific recognized standard, so the evidence supports product compliance certification but not a clearly verifiable management-system certification.
Production capacityProduction infrastructure includes molding, extrusion, and sterilizing facilities, with a one-month stated lead time in both peak and off-season periods and 19 years of export experience. However, the supplier has no in-stock capacity and no valid manufacturing-capacity contract with related subcontractors, so production capability is supported but includes operational limitations.
Customization capabilityThe supplier explicitly supports customization from samples, customization from designs, full customization, minor customization, and flexible customization, and also offers ODM and OEM services for popular brands. These statements directly evidence broad customization capability, although 3D software design is not provided.

Product Q&A

Q:What certifications does this oxygen mask have?
A:
The mask is CE, ISO13485, and FDA certified as a Class II medical device.
Q:Can the tube length be customized?
A:
Yes, the length of the tube can be customized according to your requirements.
Q:What is the minimum order quantity?
A:
The minimum order quantity is 5000 pieces.
Q:Is the mask suitable for home use?
A:
Yes, it is suitable for both hospital and home usage.
Q:What is the quality guarantee period?
A:
The product comes with a 5-year quality guarantee period.

Send Inquiry

*To:Haiyan Kangyuan Medical Instrument Co., Ltd.Haiyan Kangyuan Medical Instrument Co., Ltd.
*Content:
0/4000

Supplier replies will be sent to your registered email

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