LUBRICATED CONDOM— 510(k) K953583

Substantially Equivalent

Tactyl Technologies, Inc.

FDA 510(k) clearance K953583 for LUBRICATED CONDOM, Substantially Equivalent on 1996-01-26. Applicant: Tactyl Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Tactyl Technologies, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1995-08-01
Decision date: 1996-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, 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 Tactyl Technologies, Inc.

K955464 — TACTYLON POWDER FREE EXAMINATION GLOVE1996-04-25
K955419 — POWDER FREE TACTYLON SURGEONS GLOVE1996-04-15
K950185 — TACTYLON(TM) POWDER FREE SURGEONS GLOVE1995-04-13
K911431 — TACTYLON(TM) CONDOM1994-12-27
K905109 — PATIENT EXAMINATION GLOVE/HYPOALLERGENIC1990-11-21

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