# Thantex Specialties, Inc.

- Location (FDA's records): Norcross, GA
- FDA decisions: 21 (1994–1997): 21 510(k) clearances
- Product codes: GDY (7), EFQ (3), KKX (3), FMI (2), FYA (2), LYU (1), FXP (1), FYC (1), KME (1)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 3 (1 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
- Wcm Waste & Compliance Management, Inc.: 2 (https://510kreport.com/company/wcm-waste-compliance-management)

## Its most-cited devices
- K943626: Isolyser Sharps Management System SMS (1995), cited by 3

## Recent decisions
- K970547: Isolyser SDS Sharps Container (Jul 18, 1997)
- K961083: Orex Surgeon's Vest (Aug 23, 1996)
- K942200: Isolyser Orex Surgeon's Caps, Hoods, Bouffant Caps (Aug 7, 1995)
- K943626: Isolyser Sharps Management System SMS (Jun 16, 1995)
- K945755: Orex (R) O.R Equipment Drapes (May 25, 1995)
- K945223: Orex Isolation Gown (Apr 25, 1995)
- K944859: Orex Surgical Drapes (Feb 28, 1995)
- K944827: Orex Surgeon's Gown (Feb 28, 1995)

Source page: https://510kreport.com/company/thantex-specialties