Metacure Surgical Gloves Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 2
What Metacure Surgical Gloves Sdn Bhd makes
Metacure Surgical Gloves Sdn Bhd manufactures surgical gloves and powder-free latex examination gloves in varying thicknesses and colors, including 18 mils (blue) and 9/10 mils (natural). These products are designed for medical and examination use to maintain sterility and reduce contamination risks during procedures.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed via the 510(k) pathway. The manufacturer is based in the United States, adhering to U.S. regulatory requirements for these products.
Catalogue
Surgi Gloves Ref K073447
Regimes: 510(k) Registry: 510(k)Powder-Free Latex Examination Gloves - 18 Mils At Finger, Blue Color; 9 And 10 Mils At Finger, Natural Color Ref K072197
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Metacure Surgical Gloves Sdn Bhd have in the registry?
The registry currently lists 2 devices for Metacure Surgical Gloves Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Metacure Surgical Gloves Sdn Bhd's devices?
Among its 2 most recently registered devices, Metacure Surgical Gloves Sdn Bhd has devices listed in FDA 510(k) (2 devices).
What risk classes do Metacure Surgical Gloves Sdn Bhd's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Metacure Surgical Gloves Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Metacure Surgical Gloves Sdn Bhd in the registry?
The most recently registered devices listed for Metacure Surgical Gloves Sdn Bhd include SURGI GLOVES and POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR.