TROJAN (TM-TBD) CONDOM— 510(k) K912901

Substantially Equivalent

Carter Products

FDA 510(k) clearance K912901 for TROJAN (TM-TBD) CONDOM, Substantially Equivalent on 1992-02-03. Applicant: Carter Products. Device class: 2.

Clearance details

Applicant: Carter Products
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1991-07-02
Decision date: 1992-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIS

K252622 — Male Latex Condom HA2026-05-04
K252521 — LifeStyles® HydraFeel Natural Rubber Latex Condom2025-11-18
K250034 — Natural rubber latex male condom2025-07-11
K243421 — Lelo Hex Lubricated Natural Rubber Latex Condom2025-03-07
K243640 — Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)2025-02-21

More clearances from Carter Products

K955672 — TROJAN POLYURETHANE CONDOM (MODIFICATION)1996-08-29
K942697 — TROJAN POLYURETHANE CONDOM1995-06-22
K904782 — ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST1990-12-06
K904273 — MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.1990-10-31
K901202 — TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED1990-06-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.