# One Glove Industrial Sdn Bhd

- Location (FDA's records): Taiping, MY
- FDA decisions: 4 (2022–2022): 4 510(k) clearances
- Product codes: LZA (4)
- 510(k) review time since 2016: median 86 days, against 111 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K220431: Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile (Jun 17, 2022)
- K220429: Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile (May 13, 2022)
- K220428: Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile (May 10, 2022)
- K220427: White Nitrile Powder-Free Patient Examination Glove, Non Sterile (May 10, 2022)

Source page: https://510kreport.com/company/one-glove-industrial-sdn-bhd