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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
AvailableType
Oxygen MaskMaterial
Medcial Grade PVCModel NO.
Oxygen MaskEthylene Oxide Sterilization
Ethylene Oxide SterilizationQuality Guarantee Period
5 YearsGroup
AllLogo Printing
NegotiablePackage
1PC/Bag, 100PCS/CartonUsage
Hospital and HomeSingle Use
YesFactory
YesMedical Classification
Class IIRegistration Documents
AvailableCertification
CE, ISO13485, FDATransport Package
Carton 48*36*27cmSpecification
S, M, L, XLTrademark
MADEWELL or OEMOrigin
Zhejiang JiaxingHS Code
9020000000Production Capacity
800000 PCS Per MothKey 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
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:
Supplier replies will be sent to your registered email
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