Home / 510(k) Clearances / K901194

510(k) K901194

TROJAN RIBBED LUBRI. LATEX CONDOMS MODIFIED LABEL by Carter Products — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1990
Date Received
March 12, 1990
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 Carter Products

  • K955672 — TROJAN POLYURETHANE CONDOM (MODIFICATION) (August 29, 1996)
  • K942697 — TROJAN POLYURETHANE CONDOM (June 22, 1995)
  • 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)
  • 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)
  • K901196 — TROJAN FOR WOMEN LUBRI. CONDOMS MODIFIED LABELING (April 16, 1990)

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)
  • K243640 — Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed E (February 21, 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)