# Sempermed USA, Inc.

- Location (FDA's records): Palm Harbor, FL
- FDA decisions: 2 (2001–2001): 2 510(k) clearances
- Product codes: LYY (2)
- Predicates its devices cite: 0 (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

## Recent decisions
- K011407: Latex Powder-Free Examination Gloves Blue, Polymer Coated, Contains 50 Micrograms or Less of Total Water Extractable Pro (Sep 11, 2001)
- K011749: Latex Powdered Patient Examination Glove, 200 Micrograms or Less (Aug 22, 2001)

Source page: https://510kreport.com/company/sempermed-usa
