Pinnacle Co., Ltd.
ChinaFDA applicant, unverified FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Pinnacle Co., Ltd. makes
Pinnacle Co., Ltd. manufactures vinyl examination gloves, including powdered and powder-free variants, as well as synthetic vinyl gloves in yellow and white colors. These products are designed for single-use medical and clinical examinations to maintain hygiene and reduce contamination risk.
The company’s portfolio is regulated under FDA 510(k) clearance as Class I medical devices. These products are listed in the FDA’s 510(k) database and comply with U.S. regulatory requirements for examination gloves.
Catalogue
Vinyl Examination Glove, Powdered Ref K072223
Regimes: 510(k) Registry: 510(k)Vinyl Examination Glove Powder Free Ref K072227
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA establishments
- Pinnacle Co., Ltd Linzi, Zibo Shandong · CN FEI 3006946173
Frequently asked questions
How many devices does Pinnacle Co., Ltd. have in the registry?
The registry currently lists 3 devices for Pinnacle Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pinnacle Co., Ltd.'s devices?
Among its 3 most recently registered devices, Pinnacle Co., Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Pinnacle Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Pinnacle Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pinnacle Co., Ltd. in the registry?
The most recently registered devices listed for Pinnacle Co., Ltd. include VINYL EXAMINATION GLOVE, POWDERED, VINYL EXAMINATION GLOVE POWDER FREE and SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE).
Which FDA establishments are linked to Pinnacle Co., Ltd.?
1 FDA establishment is linked to Pinnacle Co., Ltd. in the registry; they are listed on the company page.