# Fitone Latex Products Co., Ltd. Guangdong

- Location (FDA's records): Zhanjiang, CN
- FDA decisions: 4 (2021–2023): 4 510(k) clearances
- Product codes: LZA (2), LYY (1), KGO (1)
- 510(k) review time since 2016: median 120 days, against 131 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 4 (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

## Firms whose devices it cites most
- Guangdong Kingfa Sci. & Tech.Co., Ltd.: 2 (https://510kreport.com/company/guangdong-kingfa-sci-tech)
- Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.: 1 (https://510kreport.com/company/jiangxi-kemei-medical-apparatus-instruments-group)
- Pentavest Holdings Sdn Bhd: 1 (https://510kreport.com/company/pentavest-holdings-sdn-bhd)

## Recent decisions
- K231446: Single-Use Latex Sterile Surgical Gloves (SG100) (Sep 22, 2023)
- K221747: Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs (Dec 1, 2022)
- K222693: Single-use medical latex examination gloves (LG100) (Sep 24, 2022)
- K211927: Nitrile examination gloves (Oct 12, 2021)

Source page: https://510kreport.com/company/fitone-latex-products-co-guangdong