Flexitech Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 6
What Flexitech Sdn. Bhd. makes
Flexitech Sdn. Bhd. manufactures examination gloves, including powder-free nitrile and latex variants, as well as prepowdered nitrile and latex options. Their product line includes polymer-coated nitrile gloves and latex gloves with specified protein content labeling claims (≤50 or ≤100 micrograms).
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Powder Free Nitrile Examination Gloves Ref K990495
Regimes: 510(k) Registry: 510(k)Prepowdered Nitrile Examination Gloves Ref K990499
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Prepowdered Latex Examination Gloves With Protein Content Labeling Claim (100 Micrograms Or Less) Ref K990502
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Flexitech Sdn. Bhd. have in the registry?
The registry currently lists 6 devices for Flexitech Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Flexitech Sdn. Bhd.'s devices?
Among its 6 most recently registered devices, Flexitech Sdn. Bhd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Flexitech Sdn. Bhd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Flexitech Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Flexitech Sdn. Bhd. in the registry?
The most recently registered devices listed for Flexitech Sdn. Bhd. include POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, POWDER FREE NITRILE EXAMINATION GLOVES, PREPOWDERED NITRILE EXAMINATION GLOVES and POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS).