Data / Medical devices / United States / Ansell Healthcare Products LLC
Ansell Healthcare Products LLC: FDA-registered device maker in Iselin, NJ, United States, 5 510(k) clearances
Ansell Healthcare Products LLC is registered with the FDA (registration 3009964047) in Iselin, NJ, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 20, 2021. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009964047
- Address
- 111 Wood Ave S Suite 210, Iselin, NJ, United States, 08830
- Owner or operator
- ANSELL HEALTHCARE PRODUCTS LLC (8020065)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 24, 2017
- Registered through
- 2026
- Brand names listed
- LATEX EXAMINATION GLOVE, POWDER FREE WITH PROTEN CONTENT LABELING CLAIM (50 ug/g or less of total extractable Protein)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 20, 2021 | K203705 | Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) | LYY | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| October 9, 2015 | K151528 | Powder Free Nitrile (Black) Examination Gloves | LZA | Substantially Equivalent | Gallant Quality Sdn. Bhd. | accessdata.fda.gov |
| July 24, 2014 | K140890 | NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| July 25, 2003 | K031580 | NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | Green Prospect Sdn Bhd | accessdata.fda.gov |
| February 7, 1997 | K964148 | PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 24, 2016 | 75737 | Class II | Terminated | Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured fo | Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove. | accessdata.fda.gov |
| January 14, 2013 | 64246 | Class II | Terminated | LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contrac | Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking t | accessdata.fda.gov |
Compare with other makers
Updated August 20, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.