# Regent Medical Americas, LLC

- Location (FDA's records): Norcross, GA
- FDA decisions: 7 (2005–2006): 7 510(k) clearances
- Product codes: KGO (7)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 8 (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 that cite its devices most
- Molnlycke Health Care Us, LLC: 7 (https://510kreport.com/company/molnlycke-health-care-us)
- Ssl Americas, Inc.: 1 (https://510kreport.com/company/ssl-americas)

## Its most-cited devices
- K050184: Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex Glove (2005), cited by 5
- K053443: Biogel Eclipse Non-Pyrogenic Latex Powder-Free Sterile Surgeon's Glove (2006), cited by 2
- K053102: Biogel Skinsense Powder-Free Non-Latex Surgeon's Glove (2006), cited by 1

## Recent decisions
- K053441: Biogel Latex Powder Free Sterile Surgeon's Glove (Apr 10, 2006)
- K053102: Biogel Skinsense Powder-Free Non-Latex Surgeon's Glove (Mar 10, 2006)
- K053442: Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex Glove (Mar 7, 2006)
- K053443: Biogel Eclipse Non-Pyrogenic Latex Powder-Free Sterile Surgeon's Glove (Feb 1, 2006)
- K050899: Biogel Latex Sterile Powder-Free Glove (Aug 12, 2005)
- K050533: Eclipse Latex Powder Free Sterile Surgeon's Glove (Apr 26, 2005)
- K050184: Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex Glove (Mar 16, 2005)

Source page: https://510kreport.com/company/regent-medical-americas