PVC Oxygen Mask for Single Use CE FDA ISO13485

Name: PVC Oxygen Mask for Single Use CE FDA ISO13485
Brand: Haiyan Kangyuan Medical Instrument Co., Ltd.
SKU: 1921635195

Zhejiang, ChinaHaiyan Kangyuan Medical Instrument Co., Ltd.

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

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

Company profile

Importers and ExportersHigh Repeat Buyers ChoiceYears of Export ExperienceProduct Certification

Haiyan Kangyuan Medical Instrument Co., Ltd.

Zhejiang, China

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.