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510(k) K232470

Polyisoprene Extra Large Condom by Suretex Limited — Product Code MOL

K232470 is an FDA 510(k) premarket notification submitted by Suretex Limited for the device "Polyisoprene Extra Large Condom". The FDA issued a decision of Substantially Equivalent on May 9, 2024. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Suretex Limited has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2024
Date Received
August 16, 2023
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Suretex Limited

  • K252521 — LifeStyles® HydraFeel Natural Rubber Latex Condom (November 18, 2025)
  • K231908 — 45 Micron Polyisoprene Condom (October 27, 2023)
  • K232279 — LifeStyles NRL Textured Condom (October 5, 2023)
  • K221243 — OFNat Lubricant (L15) (September 30, 2022)
  • K213921 — Microthin Natural Rubber Latex Condom (April 28, 2022)

Other clearances for product code MOL

  • K252158 — Sagami Original 002 Polyurethane Male Condom (March 30, 2026)
  • K243967 — ONE Nitrile Condom (April 8, 2025)
  • K241617 — Durex Polyisoprene Condom (February 28, 2025)
  • K240379 — TROJAN SIS Synthetic Latex Condom with Silicone Lubricant (October 8, 2024)
  • K240896 — ONE Nitrile Condom (August 23, 2024)
  • K231908 — 45 Micron Polyisoprene Condom (October 27, 2023)
  • K203541 — Okamoto 002 Lubricated Polyurethane Male Condom (February 25, 2022)
  • K182438 — Synthetic Polyisoprene Lubricated Male Condom - 5 senses (December 6, 2018)
  • K171172 — Skyn Original Polyisoprene Lubricated Male Condom - Flavored (August 2, 2017)
  • K171639 — Trojan Supra Lubricated Polyurethane Male Condom (August 1, 2017)

FDA data resources