PROTEX CONTRACEPT PLUS W/SPERM-LUB— 510(k) K842185

Name: FDA 510(k) clearance K842185
Creator: U.S. Food and Drug Administration
Published: 1984-07-31

Substantially Equivalent

National Sanitary Laboratories, Inc.

FDA 510(k) clearance K842185 for PROTEX CONTRACEPT PLUS W/SPERM-LUB, Substantially Equivalent on 1984-07-31. Applicant: National Sanitary Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: National Sanitary Laboratories, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1984-06-01
Decision date: 1984-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 National Sanitary Laboratories, Inc.

view all

K831816 — PROTEX CONTRACEPT PLUS W/SPERM-LUB1983-09-12

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