# Isikel Manufacturing, LLC

- Location (FDA's records): Katy, TX
- FDA decisions: 1 (2023–2023): 1 510(k) clearance
- Product codes: LZA (1)
- Predicates its devices cite: 1 (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
- Pt. Shamrock Manufacturing Corpora: 1 (https://510kreport.com/company/pt-shamrock-manufacturing-corpora)

## Recent decisions
- K232064: Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) (Oct 2, 2023)

Source page: https://510kreport.com/company/isikel-manufacturing