# Hong Seng Gloves Sdn Bhd

- Location (FDA's records): Sungai Petani, MY
- FDA decisions: 4 (2021–2022): 4 510(k) clearances
- Product codes: LZA (4)
- 510(k) review time since 2016: median 110 days, against 111 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 3 (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
- Shandong Xingyu Gloves Co., Ltd.: 1 (https://510kreport.com/company/shandong-xingyu-gloves)
- Jr Engineering & Medical Technologies (M) Sdn. Bhd.: 1 (https://510kreport.com/company/jr-engineering-medical-technologies-m-sdn-bhd)
- Ever Growth (Vietnam) Co., Ltd.: 1 (https://510kreport.com/company/ever-growth-vietnam)

## Recent decisions
- K221164: Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl (Aug 30, 2022)
- K212801: Powder free nitrile examination glove- black, non sterile (Jan 9, 2022)
- K212802: powder free nitrile examination glove - white, non-sterile (Dec 2, 2021)
- K212804: Powder free nitrile examination glove- blue, non-sterile (Dec 1, 2021)

Source page: https://510kreport.com/company/hong-seng-gloves-sdn-bhd