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510(k) K922688

EXTRA PROTECTION POLYURETHANE CONDOM by Apex Medical Technologies, Inc. — Product Code MOL

K922688 is an FDA 510(k) premarket notification submitted by Apex Medical Technologies, Inc. for the device "EXTRA PROTECTION POLYURETHANE CONDOM". The FDA issued a decision of Substantially Equivalent on May 4, 1995. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Apex Medical Technologies, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1995
Date Received
June 4, 1992
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 Apex Medical Technologies, Inc.

  • K112165 — RHEA CUP (May 24, 2012)
  • K060933 — SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM (May 9, 2006)
  • K954791 — SEMINAL FLUID COLLECTION KIT II (January 5, 1996)
  • K930313 — APEX SPECIMEN BAG (March 18, 1993)
  • K902936 — POLYURETHANE CONDOM (March 6, 1991)
  • K871358 — SENSATIONS BRAND CONDOMS (March 1, 1989)
  • K874539 — HI-TOUCH (TM) BRAND SURGICAL GLOVES (December 14, 1987)

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)
  • 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)

FDA data resources