Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

DUREX Real Feel Non-Latex Condom

Model 00302340894562 · RECKITT BENCKISER LLC · DI 00302340894562

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 (0)

No recalls linked in the loaded window.

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.

11222022-11: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1/device110111
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-1101
2023-0102
2025-1101
This device (reports/month)Average device in MOL (reports/device/month)

Regulatory clearances

  • K241617 SESE 2025-02-28 (k number procode)

Manufacturer compliance record — RECKITT BENCKISER LLC

  • VAI 2024-08-16 SSL Manufacturing (Thailand) LTD. · 2 citations
  • NAI 2022-09-01 Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd. · 0 citations
  • VAI 2016-05-12 Reckitt Benckiser, LLC · 4 citations
  • VAI 2016-05-12 Reckitt Benckiser, LLC · 4 citations
  • NAI 2015-05-15 RB Health (US) LLC · 0 citations
  • NAI 2014-07-10 Qingdao London Durex Co., Ltd. · 0 citations
  • NAI 2012-06-20 SSL Manufacturing (Thailand) LTD. · 0 citations