Home / 510(k) Clearances / K243640

510(k) K243640

Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) by Church & Dwight Co., Inc. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2025
Date Received
November 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

Other clearances by Church & Dwight Co., Inc.

  • K240379 — TROJAN SIS Synthetic Latex Condom with Silicone Lubricant (October 8, 2024)
  • K221906 — TROJAN Fire & Ice lubricated male natural rubber latex condom (September 28, 2022)
  • K221431 — TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lu (July 14, 2022)
  • K203818 — Replens Long-Lasting Vaginal Moisturizer (June 11, 2021)
  • K193450 — Pre-Seed™ Fertility Lubricant (July 23, 2020)
  • K180764 — TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) (August 1, 2018)
  • K180104 — Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant (March 14, 2018)
  • K171639 — Trojan Supra Lubricated Polyurethane Male Condom (August 1, 2017)
  • K161915 — Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubri (September 9, 2016)
  • K161544 — Trojan Chain Reaction Personal Lubricant (August 31, 2016)

Other clearances for product code HIS

  • K252521 — LifeStyles® HydraFeel Natural Rubber Latex Condom (November 18, 2025)
  • K250034 — Natural rubber latex male condom (July 11, 2025)
  • K243421 — Lelo Hex Lubricated Natural Rubber Latex Condom (March 7, 2025)
  • K243584 — 0.04 ZERO ZERO FOUR Male Latex Condom (February 18, 2025)
  • K232279 — LifeStyles NRL Textured Condom (October 5, 2023)
  • K230049 — SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE (September 7, 2023)
  • K222611 — Male Latex Condoms (November 28, 2022)
  • K220489 — Durex Patronus CloseFit, Durex Patronus Regular (November 7, 2022)
  • K222068 — Durex Penck III Regular (October 12, 2022)
  • K221906 — TROJAN Fire & Ice lubricated male natural rubber latex condom (September 28, 2022)