# Sime Health, Ltd.

- Location (FDA's records): Seattle, WA
- FDA decisions: 11 (1991–1995): 11 510(k) clearances
- Product codes: HIS (5), LYY (4), KGO (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (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
- Suretex Prophylactics (India), Ltd.: 3 (https://510kreport.com/company/suretex-prophylactics-india)
- G. Premjee (Usa), Inc.: 2 (https://510kreport.com/company/g-premjee-usa)
- Unidus Corp.: 1 (https://510kreport.com/company/unidus)

## Its most-cited devices
- K932982: Spermicidal Lubric. Condoms (Essentials, MI Vida, Jiffi) (1994), cited by 3
- K932983: Colored Condoms (Essentials, MI Vida, Jiffi) (1994), cited by 3

## Recent decisions
- K954051: Sime Powderfree Plus (Nov 15, 1995)
- K954025: Sime Surgical Powderfree (Nov 15, 1995)
- K932985: Aromatic Condom, Essentials, MI Vida & Jiffi (Jun 16, 1995)
- K932982: Spermicidal Lubric. Condoms (Essentials, MI Vida, Jiffi) (Jul 7, 1994)
- K932983: Colored Condoms (Essentials, MI Vida, Jiffi) (Jul 7, 1994)
- K932984: Unlubricated Condom, Essentials, MI Vida & Jiffi (Jul 7, 1994)
- K940797: Sime Surgical Latex Glove (May 9, 1994)
- K931491: Sime Health Sime Hypoallergenic (Oct 15, 1993)

Source page: https://510kreport.com/company/sime-health