WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED— 510(k) K971028

Name: FDA 510(k) clearance K971028
Creator: U.S. Food and Drug Administration
Published: 1998-03-02

Substantially Equivalent

Worlds-Best Gummivarefabrik A/S

FDA 510(k) clearance K971028 for WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED, Substantially Equivalent on 1998-03-02. Applicant: Worlds-Best Gummivarefabrik A/S. Device class: 2.

Clearance details

Applicant: Worlds-Best Gummivarefabrik A/S
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1997-03-20
Decision date: 1998-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Viby J., DK

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

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