Formtex Medical Sdn. Bhd.
MalaysiaFDA 510(k) applicant, unverified
- Devices
- 3
What Formtex Medical Sdn. Bhd. makes
Formtex Medical produces powder-free latex examination gloves and non-sterile latex dental procedure gloves, designed for medical and dental use. The company also manufactures GAMASHIELD, a protective barrier device for medical applications.
These products are classified as Class I medical devices and are listed under the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Gamashield Ref K900298
510(k) 510(k)Latex Examination Glove Powder Free Formtex Ref K931427
510(k) 510(k)Non-Sterile Latex Dental Procedure Gloves Ref K903857
510(k) 510(k)
Frequently asked questions
How many devices does Formtex Medical Sdn. Bhd. have in the registry?
The registry currently lists 3 devices for Formtex Medical Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Formtex Medical Sdn. Bhd.'s devices?
Among its 3 most recently registered devices, Formtex Medical Sdn. Bhd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Formtex Medical Sdn. Bhd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Formtex Medical Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Formtex Medical Sdn. Bhd. in the registry?
The most recently registered devices listed for Formtex Medical Sdn. Bhd. include GAMASHIELD, LATEX EXAMINATION GLOVE POWDER FREE FORMTEX and NON-STERILE LATEX DENTAL PROCEDURE GLOVES.