MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR— 510(k) K023333

Name: FDA 510(k) clearance K023333
Creator: U.S. Food and Drug Administration
Published: 2003-06-23

Substantially Equivalent

Pleasure Latex Products Sdn. Bhd.

FDA 510(k) clearance K023333 for MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR, Substantially Equivalent on 2003-06-23. Applicant: Pleasure Latex Products Sdn. Bhd.. Device class: 2.

Clearance details

Applicant: Pleasure Latex Products Sdn. Bhd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2002-10-07
Decision date: 2003-06-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Jeram, Selangor Darul Ehsan, MY

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 Pleasure Latex Products Sdn. Bhd.

view all

K022156 — LATEX ULTRASONIC PROBE COVER2003-09-11
K021875 — MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM2002-09-05
K020272 — MALE LATEX CONDOM WITH RIBBED SURFACE2002-04-26
K002571 — MULITPLE MALE LATX CONDOM2000-11-16
K001377 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM2000-06-08

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