Top Calibre Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 5
What Top Calibre Sdn Bhd makes
Top Calibre Sdn Bhd manufactures single-use patient examination gloves, including powder-free nitrile and latex varieties, as well as powdered latex gloves. The portfolio includes latex gloves with protein content labeling claims under specific regulatory conditions.
These devices are classified as Class I under global regulatory frameworks and are listed via FDA 510(k) clearance in the United States. The company is based in Malaysia.
Catalogue
Latex Examination Gloves (Powder Free) Ref K120692
Regimes: 510(k) Registry: 510(k)Powder Free Nitrile Patient Examination Glove Ref K133949
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Latex Examination Gloves (Powdered) Ref K120693
Regimes: 510(k) Registry: 510(k)Multiple Name Ref K123819
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Top Calibre Sdn Bhd have in the registry?
The registry currently lists 5 devices for Top Calibre Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Top Calibre Sdn Bhd's devices?
Among its 5 most recently registered devices, Top Calibre Sdn Bhd has devices listed in FDA 510(k) (5 devices).
What risk classes do Top Calibre Sdn Bhd's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Top Calibre Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Top Calibre Sdn Bhd in the registry?
The most recently registered devices listed for Top Calibre Sdn Bhd include LATEX EXAMINATION GLOVES (POWDER FREE), POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM and LATEX EXAMINATION GLOVES (POWDERED).