Straitscom
Country not established
- Devices
- 3
What Straitscom makes
Straitscom manufactures surgical gloves for surgeons and hypoallergenic latex examination gloves for medical examinations. These products are designed for single-use in clinical settings to reduce contamination risk and minimize allergic reactions.
The company’s portfolio is regulated as Class I medical devices under FDA 510(k) clearance requirements. The devices are listed in the FDA’s 510(k) database, and the company is based in the United States.
Catalogue
Non-Sterile Exam Gloves Ref K885319
Regimes: 510(k) Registry: 510(k)Surgeon's (Surgical) Gloves Ref K903534
Regimes: 510(k) Registry: 510(k)Hypoallergenic Latex Examination Gloves Ref K910009
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Straitscom have in the registry?
The registry currently lists 3 devices for Straitscom. Devices recorded under merged duplicate company entries are counted once.
Which registries list Straitscom's devices?
Among its 3 most recently registered devices, Straitscom has devices listed in FDA 510(k) (3 devices).
What risk classes do Straitscom's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Straitscom's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Straitscom in the registry?
The most recently registered devices listed for Straitscom include NON-STERILE EXAM GLOVES, SURGEON'S (SURGICAL) GLOVES and HYPOALLERGENIC LATEX EXAMINATION GLOVES.