Concept Rubber Products Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 2
What Concept Rubber Products Sdn Bhd makes
Concept Rubber Products Sdn Bhd manufactures latex patient examination gloves, including standard latex gloves and powder-free latex gloves with a protein content claim of 50 micrograms or less.
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 US.
Catalogue
Alamtex Patient Examination Gloves (Latex) Ref K891966
Regimes: 510(k) Registry: 510(k)Almatex Powder-Free Latex Exanination Gloves With Protien Labeling Claim 50 Micrograms Or Less Ref K003213
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Concept Rubber Products Sdn Bhd have in the registry?
The registry currently lists 2 devices for Concept Rubber Products Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Concept Rubber Products Sdn Bhd's devices?
Among its 2 most recently registered devices, Concept Rubber Products Sdn Bhd has devices listed in FDA 510(k) (2 devices).
What risk classes do Concept Rubber Products Sdn Bhd's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Concept Rubber Products Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Concept Rubber Products Sdn Bhd in the registry?
The most recently registered devices listed for Concept Rubber Products Sdn Bhd include ALAMTEX PATIENT EXAMINATION GLOVES (LATEX) and ALMATEX POWDER-FREE LATEX EXANINATION GLOVES WITH PROTIEN LABELING CLAIM 50 MICROGRAMS OR LESS.