Lovytex Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 3
What Lovytex Sdn Bhd makes
Lovytex Sdn Bhd manufactures powder-free examination gloves, including latex, nitrile, and polymer-coated latex variants designed for medical and clinical use. These products are intended for single-use protection during procedures requiring sterile barriers, such as patient examinations and minor surgical interventions.
The company’s portfolio is classified under Class I medical devices and is listed in the FDA’s 510(k) registry. The manufacturer is based in the US, adhering to regulatory requirements for examination gloves under this classification.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Lovytex Powder-Free Nitrile Examination Gloves Ref K981179
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lovytex Sdn Bhd have in the registry?
The registry currently lists 3 devices for Lovytex Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lovytex Sdn Bhd's devices?
Among its 3 most recently registered devices, Lovytex Sdn Bhd has devices listed in FDA 510(k) (3 devices).
What risk classes do Lovytex Sdn Bhd's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Lovytex Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Lovytex Sdn Bhd in the registry?
The most recently registered devices listed for Lovytex Sdn Bhd include LOVYTEX SDN BHD POWDER-FREE LATEX EXAMINATION GLOVES, LOVYTEX POWDER-FREE NITRILE EXAMINATION GLOVES and LOVYTEX SND BHD POWDER-FREE POLYMER COATED LATEX EXAMINATION GLOVES.