MENTOR PLUS (CONDOM)— 510(k) K874383

Substantially Equivalent

Arcon Corp.

FDA 510(k) clearance K874383 for MENTOR PLUS (CONDOM), Substantially Equivalent on 1988-03-07. Applicant: Arcon Corp.. Device class: 2.

Clearance details

Applicant: Arcon Corp.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1987-10-26
Decision date: 1988-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stewartville, MN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K874383

K-number listed on FDA's recall record

Z-1181-2026 — Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLUE, TROJAN ULTRA THIN CONDOMS 6/DSP GREY, TROJAN RIBBED CONDOMS 6/DSP GOLD/BROWN, TROJAN NONLUBRICATED CONDOMS 6/DSP RED, TROJAN ULTRA HER PLEASURE CONDOMS 6/DSP, TROJAN CONDOMS MAGNUM 48 CT DISP, *BOX TROJAN CONDOMS MAGNUM 50CT .Class II·Ongoing·GOLD STAR DISTRIBUTION INC·20251226

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K874383.

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