Home / 510(k) Clearances / K942697

510(k) K942697

TROJAN POLYURETHANE CONDOM by Carter Products — Product Code MOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1995
Date Received
June 8, 1994
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 Carter Products

  • K955672 — TROJAN POLYURETHANE CONDOM (MODIFICATION) (August 29, 1996)
  • K912901 — TROJAN (TM-TBD) CONDOM (February 3, 1992)
  • K904782 — ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST (December 6, 1990)
  • K904273 — MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB. (October 31, 1990)
  • K901202 — TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED (June 19, 1990)
  • K901201 — TROJAN RIBBED LATEX CONDOMS W/SPERM. MODIFIED (April 16, 1990)
  • K901190 — TROJANS LATEX CONDOMS (MODIFIED LABELING) (April 16, 1990)
  • K901197 — TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL (April 16, 1990)
  • K901191 — TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING) (April 16, 1990)
  • K901198 — TROJAN PLUS 2 LATEX CONDOMS W/SPERMICIDAL MODIFIED (April 16, 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)