JIFFI CONDOM (RUBBER) CONTRACEPTIVE— 510(k) K913813

Name: FDA 510(k) clearance K913813
Creator: U.S. Food and Drug Administration
Published: 1992-06-01

Substantially Equivalent

Sime Health, Ltd.

FDA 510(k) clearance K913813 for JIFFI CONDOM (RUBBER) CONTRACEPTIVE, Substantially Equivalent on 1992-06-01. Applicant: Sime Health, Ltd.. Device class: 2.

Clearance details

Applicant: Sime Health, Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1991-08-26
Decision date: 1992-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

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 Sime Health, Ltd.

view all

K954025 — SIME SURGICAL POWDERFREE1995-11-15
K954051 — SIME POWDERFREE PLUS1995-11-15
K932985 — AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI1995-06-16
K932982 — SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)1994-07-07
K932983 — COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)1994-07-07

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