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Trojan™ Premium Latex Condoms Magnum™ Large Size Condoms Gold Pack

Model 00022600643203 · CHURCH & DWIGHT CO., INC. · DI 00022600643203

HIS — Condom · Class II · 21 CFR 884.5300

UDILibrary device dossier · generated 2026-09-08 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2025-12-26Z-1181-2026Class IIOpen, ClassifiedPotential exposure of rodents and rodent activity in the distribution center.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.

11222019-05: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 2/device0511051011081201030510120712070811
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0501
2019-1101
2020-0501
2020-1001
2020-1101
2021-0801
2021-1201
2022-0101
2022-0301
2022-0501
2022-1002
2022-1201
2023-0701
2024-1201
2025-0701
2025-0802
2025-1102
This device (reports/month)Average device in HIS (reports/device/month)

Regulatory clearances

  • K120249 SESE 2012-05-11 (k number procode)

Predicate lineage

K120249 — cites (transitively): K000748 (d1), K895640 (d1) — cited as predicate by K221431

K120286 — cites (transitively): K912901 (d1) — cited as predicate by K243640

K895640 — cited as predicate by K120249

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — CHURCH & DWIGHT CO., INC.

  • Warning Letter 2011-05-16 Church & Dwight Inc
  • Warning Letter 2011-05-16 Church & Dwight Inc
  • NAI 2024-08-12 Church & Dwight Manufacturing Co., Ltd. · 0 citations
  • NAI 2024-07-18 Church & Dwight Canada Corp. · 0 citations
  • NAI 2023-08-08 Church & Dwight Manufacturing Co., Ltd. · 0 citations
  • NAI 2022-07-15 Church & Dwight Manufacturing Co., Ltd. · 0 citations
  • NAI 2020-08-14 Church & Dwight Inc · 0 citations
  • NAI 2020-08-14 Church & Dwight Inc · 0 citations
  • VAI 2017-10-31 Church & Dwight Manufacturing Co., Ltd. · 1 citations
  • NAI 2015-08-06 Church & Dwight Inc · 0 citations
  • NAI 2015-08-06 Church & Dwight Inc · 0 citations
  • VAI 2015-03-13 Church & Dwight Manufacturing Co., Ltd. · 2 citations
  • VAI 2012-08-24 Church & Dwight Manufacturing Co., Ltd. · 2 citations
  • VAI 2012-02-13 Church & Dwight Inc · 5 citations
  • VAI 2012-02-13 Church & Dwight Inc · 5 citations
  • NAI 2011-02-17 Church & Dwight Co., Inc. · 0 citations
  • OAI 2011-02-17 Church & Dwight Inc · 7 citations
  • OAI 2011-02-17 Church & Dwight Inc · 7 citations
  • VAI 2010-07-08 Church & Dwight Manufacturing Co., Ltd. · 3 citations