Home / 510(k) Clearances / K252158

510(k) K252158

Sagami Original 002 Polyurethane Male Condom by Mayer Laboratories — Product Code MOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2026
Date Received
July 9, 2025
Clearance Type
Traditional
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 Mayer Laboratories

  • K130345 — AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING (August 1, 2013)
  • K113686 — KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED (March 6, 2012)
  • K110325 — AQUA LUBE (December 8, 2011)
  • K001974 — EZ-ON CONDOM (October 24, 2001)
  • K946374 — KIMONO MICROTHIN (November 8, 1995)
  • K946376 — MAXX (September 22, 1995)
  • K943064 — KIMONO (CONDOMS) (September 22, 1995)
  • K925869 — SHEATHES, STERILE SHEATHES (January 6, 1994)
  • K926049 — DIGITEX, DIGITEX HYPOALLERGENIC (July 22, 1993)
  • K904375 — KIMONO PLUS (November 26, 1990)

Other clearances for product code MOL

  • 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)
  • K232470 — Polyisoprene Extra Large Condom (May 9, 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)