# Ansell Healthcare Products, LLC

- Location (FDA's records): Dothan, AL
- FDA decisions: 36 (2000–2023): 36 510(k) clearances
- Names in FDA's records: Ansell Healthcare Products, LLC (26); Ansell Healthcare Products, Inc. (10)
- Product codes: KGO (16), LZA (10), NUC (4), MOL (3), LYY (2), HIS (1)
- 510(k) review time since 2016: median 202 days, against 185 for FDA's reviews in the same codes and years (5 of 12 faster)
- Predicates its devices cite: 24 (10 its own); citations of its devices by later devices: 33 (10 its own)
- Recalls linked to its devices: 12 (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)
- Allegiance Healthcare Corp.: 2 (https://510kreport.com/company/allegiance-healthcare)
- Ssl Americas, Inc.: 2 (https://510kreport.com/company/ssl-americas)
- Johnson & Johnson Medical, Inc.: 2 (https://510kreport.com/company/johnson-johnson-medical)
- Wells Lamont Corp.: 1 (https://510kreport.com/company/wells-lamont)
- Personal Products Co., Div. of Mcneil Ppc, Inc.: 1 (https://510kreport.com/company/personal-products-co-div-of-mcneil-ppc)
- Molnlycke Health Care Us, LLC: 1 (https://510kreport.com/company/molnlycke-health-care-us)
- Wear Safe (Malaysia) Sdn Bhd - Facility II: 1 (https://510kreport.com/company/wear-safe-malaysia-sdn-bhd-facility-ii)

## Firms that cite its devices most
- Suretex Limited: 4 (https://510kreport.com/company/suretex)
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)
- Thai Nippon Rubber Industry Co., Ltd.: 1 (https://510kreport.com/company/thai-nippon-rubber-industry)
- Ldi Corporation: 1 (https://510kreport.com/company/ldi)
- Rb Health (Us), LLC: 1 (https://510kreport.com/company/rb-health-us)
- Biotech Lubricants, Ltd.: 1 (https://510kreport.com/company/biotech-lubricants)
- Syntex Healthcare Products Co., Ltd.: 1 (https://510kreport.com/company/syntex-healthcare-products)
- Anhui Intco Medical Products Co., Ltd.: 1 (https://510kreport.com/company/anhui-intco-medical-products)

## Its most-cited devices
- K122477: Lifestyles Luxe Premium Personal Lubricant (2013), cited by 3
- K200671: Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for (2020), cited by 3
- K160399: Skyn Original Polyisoprene Lubricated Male Condom (2016), cited by 3
- K122476: Lifestyles Smooth 2-in-1 Massage & Lubricant (2013), cited by 3
- K122054: Lifestyles Natural Personal Lubricant (2013), cited by 3
- K163107: Lifestyles Zero Lubricated Latex Male Condom (2017), cited by 2

## Recent decisions
- K230079: Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential (Aug 23, 2023)
- K213289: Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs (May 26, 2023)
- K212148: Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs (Mar 10, 2022)
- K210401: Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Jun 13, 2021)
- K200671: Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for (Jun 19, 2020)
- K190018: Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs (May 23, 2019)
- K182948: Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs (Mar 22, 2019)
- K171375: Gammex PI Breach Detect Powder Free Surgical Glove (Feb 6, 2018)

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