Onetexx Sdn Bhd

FDA Regulatory Profile

Onetexx Sdn Bhd has 0 FDA recalls, 0 inspections, 7 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Oct 18, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances7Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K222298Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy…Oct 18, 2022
K222294Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy…Sep 24, 2022
K221773Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid…Jul 30, 2022
K210588Black Nitrile Powder Free Patient Examination Glove, Non SterileOct 31, 2021
K210587Violet Nitrile Powder Free Patient Examination Glove, Non SterileJun 28, 2021
K210775White Nitrile Powder Free Patient Examination Glove, Non SterileJun 28, 2021
K210366Blue Nitrile Powder Free Patient Examination Glove, Non SterileMay 7, 2021