Skypro Medical Supplies Company
ChinaFDA applicant, unverified FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Skypro Medical Supplies Company makes
Skypro Medical Supplies Company manufactures single-use surgical masks, including the SP01 Mask and SP02 Mask (3-layer), as well as disposable surgical gowns like the 6021 model. These products are designed for healthcare settings to provide barrier protection against contaminants and fluids during medical procedures.
The company’s products are regulated as Class II medical devices in the US, with each device authorised through the FDA’s 510(k) clearance process. The portfolio is listed under the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Skypro, SP01 Mask Ref K152197
Regimes: 510(k) Registry: 510(k)Skypro, Surgical Gown 6021 Ref K230707
Regimes: 510(k) Registry: 510(k)Skypro, SP02 Mask (3) Ref K202255
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Skypro Medical Supplies Company Hong Kong · HK FEI 3008191254
Frequently asked questions
How many devices does Skypro Medical Supplies Company have in the registry?
The registry currently lists 3 devices for Skypro Medical Supplies Company. Devices recorded under merged duplicate company entries are counted once.
Which registries list Skypro Medical Supplies Company's devices?
Among its 3 most recently registered devices, Skypro Medical Supplies Company has devices listed in FDA 510(k) (3 devices).
What risk classes do Skypro Medical Supplies Company's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Skypro Medical Supplies Company's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Skypro Medical Supplies Company in the registry?
The most recently registered devices listed for Skypro Medical Supplies Company include Skypro, SP01 Mask, Skypro, Surgical Gown 6021 and Skypro, SP02 Mask (3).
Which FDA establishments are linked to Skypro Medical Supplies Company?
1 FDA establishment is linked to Skypro Medical Supplies Company in the registry; they are listed on the company page.