Master & Frank Ent. Co., Ltd.
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Master & Frank Ent. Co., Ltd. makes
Master & Frank Ent. Co., Ltd. manufactures sterile surgical gowns designed for use in operating rooms and sterile procedures. These gowns are intended to provide barrier protection for healthcare personnel during surgical interventions.
The company’s surgical gowns fall under FDA Class II devices and are listed via the 510(k) pathway in the United States. The products are regulated under the jurisdiction of the FDA’s Center for Devices and Radiological Health.
Catalogue
Master & Frank Surgical Gowns (Sterile) Ref K012186
510(k) 510(k)
FDA establishments
- Master & Frank Ent. Co., Ltd. TAIPEI · TW FEI 1000346129
Frequently asked questions
How many devices does Master & Frank Ent. Co., Ltd. have in the registry?
The registry currently lists 1 device for Master & Frank Ent. Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Master & Frank Ent. Co., Ltd.'s devices?
Among its 1 most recently registered device, Master & Frank Ent. Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Master & Frank Ent. Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Master & Frank Ent. Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Master & Frank Ent. Co., Ltd. in the registry?
The most recently registered devices listed for Master & Frank Ent. Co., Ltd. include MASTER & FRANK SURGICAL GOWNS (STERILE).
Which FDA establishments are linked to Master & Frank Ent. Co., Ltd.?
1 FDA establishment is linked to Master & Frank Ent. Co., Ltd. in the registry; they are listed on the company page.