MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)— 510(k) K990925

Name: FDA 510(k) clearance K990925
Creator: U.S. Food and Drug Administration
Published: 1999-06-17

Substantially Equivalent

Hardcover Products, Inc.

FDA 510(k) clearance K990925 for MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION), Substantially Equivalent on 1999-06-17. Applicant: Hardcover Products, Inc.. Device class: 2.

Clearance details

Applicant: Hardcover Products, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1999-03-19
Decision date: 1999-06-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Concord, Ontario, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIS

view all

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 Hardcover Products, Inc.

view all

K991047 — HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)1999-06-18

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