PRIME— 510(k) K830691

Substantially Equivalent

Ansell, Inc.

FDA 510(k) clearance K830691 for PRIME, Substantially Equivalent on 1983-03-31. Applicant: Ansell, Inc.. Device class: 2.

Clearance details

Applicant: Ansell, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1983-03-01
Decision date: 1983-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Ansell, Inc.

K984392 — ANSELL CONDOMS1999-07-21
K983518 — LIFESTYLES XTRA PLEASURE1999-07-06
K940047 — SPERMICIDALLY LUBRICATED CONDOM1995-12-19
K953379 — HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE1995-09-27
K945766 — HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES1995-08-07

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