# G. Premjee (Usa), Inc.

- Location (FDA's records): Great Neck, NY
- FDA decisions: 2 (1997–1997): 2 510(k) clearances
- Product codes: LTZ (1), HIS (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Suretex Limited: 2 (https://510kreport.com/company/suretex)
- Sime Health, Ltd.: 2 (https://510kreport.com/company/sime-health)

## Recent decisions
- K972836: Royale Brand Latex Condoms-Spermicidal Lubricant - Colored or Assorted Colors (Oct 22, 1997)
- K971132: Royale Brand Latex Condoms (Silicone)-Colored/Assorted Colors (Sep 3, 1997)

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