# Suretex Prophylactics (India), Ltd.

- Location (FDA's records): Bangalore, Karnataka, IN
- FDA decisions: 3 (1998–1999): 3 510(k) clearances
- Product codes: HIS (2), LTZ (1)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sime Health, Ltd.: 3 (https://510kreport.com/company/sime-health)
- Suretex Limited: 2 (https://510kreport.com/company/suretex)

## Firms that cite its devices most
- Suretex Limited: 1 (https://510kreport.com/company/suretex)

## Its most-cited devices
- K983320: Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors (1998), cited by 2

## Recent decisions
- K992081: Various Ansell Tradenames or Private Label (Aug 19, 1999)
- K983320: Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors (Dec 11, 1998)
- K981621: Royale of Latex Condoms - Spermicidal Lubricant - Colored or Assorted Colors (Jun 19, 1998)

Source page: https://510kreport.com/company/suretex-prophylactics-india