# Primus Gloves Pvt Limited

- Location (FDA's records): Cochin, IN
- FDA decisions: 3 (2016–2017): 3 510(k) clearances
- Product codes: LZA (1), KGO (1), LYZ (1)
- 510(k) review time since 2016: median 236 days, against 111 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 4 (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
- Northstar Healthcare Holdings: 1 (https://510kreport.com/company/northstar-healthcare-holdings)
- Hebei Hongsen Plastics Technology Co, Ltd.: 1 (https://510kreport.com/company/hebei-hongsen-plastics-technology)
- Shijiazhuang Hongxiang Plastics Products Co., Ltd.: 1 (https://510kreport.com/company/shijiazhuang-hongxiang-plastics-products)

## Firms that cite its devices most
- Lalan Rubbers (Pvt), Ltd.: 1 (https://510kreport.com/company/lalan-rubbers-pvt)
- M/S Tegamen Safety Products Private Limited: 1 (https://510kreport.com/company/m-s-tegamen-safety-products-private)
- Brightway Holdings Sdn. Bhd.: 1 (https://510kreport.com/company/brightway-holdings-sdn-bhd)
- Jr Engineering & Medical Technologies (M) Sdn. Bhd.: 1 (https://510kreport.com/company/jr-engineering-medical-technologies-m-sdn-bhd)

## Its most-cited devices
- K143477: Nitrile Patient Examination gloves, Powderfree, Blue color (2016), cited by 3
- K170515: Sterile Nitrile Surgical Gloves, Powder-free (2017), cited by 1

## Recent decisions
- K170612: STERILE VINYL EXAMINATION GLOVES, Powder Free (Oct 23, 2017)
- K170515: Sterile Nitrile Surgical Gloves, Powder-free (Jun 9, 2017)
- K143477: Nitrile Patient Examination gloves, Powderfree, Blue color (Apr 14, 2016)

Source page: https://510kreport.com/company/primus-gloves-pvt