Print-ready dossier — use your browser's print dialog to save as PDF.
DUREX Avanti Bare- RealFeel Non-Latex Condom
Model Condom · RB Health (us) LLC · DI 88302340894553
MOL — Condom, Synthetic · Class II · 21 CFR 884.5300
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (4)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2018-12-19 | Z-0993-2019 | Class II | Terminated | Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. | k number procode |
| 2018-12-19 | Z-0994-2019 | Class II | Terminated | Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. | k number procode |
| 2018-08-06 | Z-0091-2019 | Class II | Terminated | Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life | k number procode |
| 2018-07-23 | Z-3241-2018 | Class II | Terminated | The products failed the filed specification of 1.0kPa for Burst Pressure. | k number procode |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2022-11 | 0 | 1 |
| 2023-01 | 0 | 2 |
| 2025-11 | 0 | 1 |
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — RB Health (us) LLC
- NAI 2015-05-15 RB Health (US) LLC · 0 citations