Encompass Industries Sdn. Bhd.
MalaysiaFDA applicant, unverified FDA FEI 3014384460
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Encompass Industries Sdn. Bhd. makes
Encompass Industries manufactures powder-free examination gloves, including nitrile and polychloroprene variants, specifically tested for compatibility with chemotherapy drugs and fentanyl. The portfolio includes gloves in multiple colors (white, blue, black, orange, and green) to meet clinical and procedural requirements.
These devices are classified as Class I under FDA regulations and are listed via 510(k) clearance. The manufacturer operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3014384460
- Address
- LOT 18256, KAWASAN PERINDUSTRIAN LOT Q, KEMAMAN Terengganu
Frequently asked questions
How many devices does Encompass Industries Sdn. Bhd. have in the registry?
The registry currently lists 3 devices for Encompass Industries Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Encompass Industries Sdn. Bhd.'s devices?
Among its 3 most recently registered devices, Encompass Industries Sdn. Bhd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Encompass Industries Sdn. Bhd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Encompass Industries Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Encompass Industries Sdn. Bhd. in the registry?
The most recently registered devices listed for Encompass Industries Sdn. Bhd. include Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color), Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl and Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs.