Windwell Agencies Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 2
What Windwell Agencies Sdn. Bhd. makes
Windwell Agencies Sdn. Bhd. manufactures latex examination gloves designed for patient care, including standard patient examination gloves and a branded line called Wintex.
These products are classified as Class I medical devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Patient Examination Gloves, Latex Ref K894454
Regimes: 510(k) Registry: 510(k)Latex Examination Gloves (Wintex) Ref K892174
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Windwell Agencies Sdn. Bhd. have in the registry?
The registry currently lists 2 devices for Windwell Agencies Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Windwell Agencies Sdn. Bhd.'s devices?
Among its 2 most recently registered devices, Windwell Agencies Sdn. Bhd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Windwell Agencies Sdn. Bhd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Windwell Agencies Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Windwell Agencies Sdn. Bhd. in the registry?
The most recently registered devices listed for Windwell Agencies Sdn. Bhd. include PATIENT EXAMINATION GLOVES, LATEX and LATEX EXAMINATION GLOVES (WINTEX).