# Ansell Healthcare, Inc.

- Location (FDA's records): Dothan, AL
- FDA decisions: 3 (2000–2023): 3 510(k) clearances
- Names in FDA's records: Ansell Healthcare, Inc. (2); Ansell Healthcare (1)
- Product codes: HIS (2), KGO (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 3 (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 whose devices it cites most
- Biofilm, Inc.: 1 (https://510kreport.com/company/biofilm)
- Ortho Pharmaceutical Corp.: 1 (https://510kreport.com/company/ortho-pharmaceutical)
- Ansell Healthcare Products, LLC: 1 (https://510kreport.com/company/ansell-healthcare-products)

## Firms that cite its devices most
- Ssl Americas, Inc.: 1 (https://510kreport.com/company/ssl-americas)
- Julie Williams, Pa-C: 1 (https://510kreport.com/company/julie-williams-pa-c)
- Trimensa Pharmaceuticals: 1 (https://510kreport.com/company/trimensa-pharmaceuticals)

## Its most-cited devices
- K033076: Lifestyles Liquid Personal Lubricant (2003), cited by 3

## Recent decisions
- K231902: GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) (Oct 20, 2023)
- K033076: Lifestyles Liquid Personal Lubricant (Dec 19, 2003)
- K001883: Lifestyles, Contempo or Private Label Large Condom (Jul 31, 2000)

Source page: https://510kreport.com/company/ansell-healthcare