Protection Gloves Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 5
What Protection Gloves Sdn. Bhd. makes
Protection Gloves Sdn. Bhd. manufactures powder-free and chlorinated latex examination gloves in blue and green colors, including versions with reduced protein content and specific water extraction limits. Their products are designed for medical examinations and procedures, with some formulations targeting low-protein residues to minimize allergic reactions.
The company’s latex examination gloves are classified as Class I medical devices under FDA regulations and are listed via 510(k) clearance. The manufacturer is based in the US, and their devices are registered in the FDA’s 510(k) database.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Multiple Ref K945164
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Protection Gloves Sdn. Bhd. have in the registry?
The registry currently lists 5 devices for Protection Gloves Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Protection Gloves Sdn. Bhd.'s devices?
Among its 5 most recently registered devices, Protection Gloves Sdn. Bhd. has devices listed in FDA 510(k) (5 devices).
What risk classes do Protection Gloves Sdn. Bhd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Protection Gloves Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Protection Gloves Sdn. Bhd. in the registry?
The most recently registered devices listed for Protection Gloves Sdn. Bhd. include CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN), POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRA, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM and CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN.