# Onetexx Sdn Bhd

- Location (FDA's records): Kamunting, MY
- FDA decisions: 7 (2021–2022): 7 510(k) clearances
- Product codes: LZA (7)
- 510(k) review time since 2016: median 88 days, against 111 for FDA's reviews in the same codes and years (5 of 7 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ever Growth (Vietnam) Co., Ltd.: 1 (https://510kreport.com/company/ever-growth-vietnam)
- Yty Industry (Manjung) Sdn Bhd: 1 (https://510kreport.com/company/yty-industry-manjung-sdn-bhd)
- Jr Engineering & Medical Technologies (M) Sdn. Bhd.: 1 (https://510kreport.com/company/jr-engineering-medical-technologies-m-sdn-bhd)
- Shandong Xingyu Gloves Co., Ltd.: 1 (https://510kreport.com/company/shandong-xingyu-gloves)

## Firms that cite its devices most
- St Future International Limited: 1 (https://510kreport.com/company/st-future-international)

## Its most-cited devices
- K210366: Blue Nitrile Powder Free Patient Examination Glove, Non Sterile (2021), cited by 1

## Recent decisions
- K222298: Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid (Oct 18, 2022)
- K222294: Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid (Sep 24, 2022)
- K221773: Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid (Jul 30, 2022)
- K210588: Black Nitrile Powder Free Patient Examination Glove, Non Sterile (Oct 31, 2021)
- K210587: Violet Nitrile Powder Free Patient Examination Glove, Non Sterile (Jun 28, 2021)
- K210775: White Nitrile Powder Free Patient Examination Glove, Non Sterile (Jun 28, 2021)
- K210366: Blue Nitrile Powder Free Patient Examination Glove, Non Sterile (May 7, 2021)

Source page: https://510kreport.com/company/onetexx-sdn-bhd