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Data / Medical devices / China / Hubei Wanli Protective Products Co.,ltd

Hubei Wanli Protective Products Co.,ltd: FDA-registered device maker in xiantao Hubei, China, 3 510(k) clearances

Hubei Wanli Protective Products Co.,ltd is registered with the FDA (registration 3008770063) in xiantao Hubei, China. It lists 15 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 6, 2022. Registered through 2027. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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FDA registration number
3008770063
Address
NO.106 West Station Huangjin Road, xiantao Hubei, China, 433000
Owner or operator
Hubei Wanli Protective Products Co.,ltd (10034851)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
January 7, 2011
Registered through
2027
Brand names listed
BOUFFANT CAP, Burn Sheet, CLIP CAP, CLIP CAP, BOUFFANT CAP, NON WOVEN CAP, PE CAP, DISPOSABLE CAP, NYLON CAP, Disposable Beard Cover, DISPOSABLE CAP, DISPOSABLE SHOE COVER, DISPOSABLE SHOE COVER, Sleeve Cover, DISPOSBALE FACE MASK and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Contract manufacturer, Manufactureraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Contract manufacturer, Manufactureraccessdata.fda.gov
Cap, SurgicalFYF1Contract manufacturer, Manufactureraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Contract manufacturer, Manufactureraccessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella EuaQKRNManufactureraccessdata.fda.gov
Gown, SurgicalFYA2Exporter to the US, Manufactureraccessdata.fda.gov
Mask, ScavengingKHA1Contract manufacturer, Manufactureraccessdata.fda.gov
Mask, SurgicalFXX2Exporter to the US, Manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Contract manufacturer, Manufactureraccessdata.fda.gov
Respirator, SurgicalMSH2Manufactureraccessdata.fda.gov
Sheet, BurnFPY1Manufactureraccessdata.fda.gov
Sling, ArmILI1Manufactureraccessdata.fda.gov
Stethoscope, ManualLDE1Exporter to the USaccessdata.fda.gov
Strap, Head, Gas MaskBTK1Manufactureraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 6, 2022K214085Disposable Medical MaskFXXSubstantially EquivalentHubei Wanli Protective Products Co., Ltd.accessdata.fda.gov
October 24, 2021K211509Surgical GownFYASubstantially EquivalentHubei Wanli Protective Products Co., Ltd.accessdata.fda.gov
June 2, 2021K210150Disposable Medical maskFXXSubstantially EquivalentHubei Wanli Protective Products Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated April 6, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.