Data / Medical devices / Condom With Nonoxynol-9
Condom With Nonoxynol-9 (LTZ): 8 FDA-registered makers in 5 countries
8 establishments in 5 countries are registered with the FDA to make Condom With Nonoxynol-9 (product code LTZ, Class 2, 21 CFR 884.5310). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 22 510(k) clearances under this code, the latest on April 27, 2004, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LTZ
- Device class
- 2
- Regulation
- 884.5310
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| India | 2 |
| Thailand | 2 |
| United States | 2 |
| Vietnam | 1 |
| Malaysia | 1 |
Makers of Condom With Nonoxynol-9
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Dongkuk Vietnam Co., Ltd. | Viet Tri Phu Tho, Vietnam | Manufacturer | 1 | April 27, 2004 | 0 | 0 | 0 | api.fda.gov |
| Indus Medicare Private Limited | Medak District Telangana, India | Manufacturer | 1 | August 2, 1999 | 0 | 0 | 0 | api.fda.gov |
| Pleasure Latex Products Sdn. Bhd. | JERAM Selangor, Malaysia | Contract manufacturer, Exporter to the US, Manufacturer | 1 | June 8, 2000 | 0 | 0 | 0 | api.fda.gov |
| Thai Nippon Rubber Industry Public Company Limited | Sriracha Chon Buri, Thailand | Manufacturer | 1 | August 8, 2000 | 0 | 0 | 0 | api.fda.gov |
| Church & Dwight Co., Inc. | Princeton, NJ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Church & Dwight Manufacturing Co., Inc. | South Chesterfield, VA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suretex, Ltd. | Amphur Phunphin Surat Thani, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suretex Prophylactics (India) Private Limited | BANGALORE Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 27, 2004. 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.