Cleared Traditional

K941258 - LATEX CONDOM

K941258 is an FDA 510(k) clearance for LATEX CONDOM, manufactured by Suretex, Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 630-day FDA review.

K941258 · Suretex, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
630d
Days
Class 2
Risk

K941258 is an FDA 510(k) clearance for the LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Suretex, Ltd. (Thailand, TH). The FDA issued a Cleared decision on December 6, 1995 after a review of 630 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Suretex, Ltd. devices

FDA 510(k) Submission Details - K941258

510(k) Number K941258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1994
Decision Date December 06, 1995
Days to Decision 630 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
470d slower than avg
Panel avg: 160d · This submission: 630d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIS Device Classification - Class 2, Special Controls

Product Code HIS Condom
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIS Condom

All 169
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K941258.
CONQUEROR, RUMBA AND TEMPTATION
K946207 · Frontline Latex Products Pvt. , Ltd. · Jan 1996
SEMINAL FLUID COLLECTION KIT II
K954791 · Apex Medical Technologies, Inc. · Jan 1996
SPERMICIDALLY LUBRICATED CONDOM
K940047 · Ansell, Inc. · Dec 1995
KIMONO MICROTHIN
K946374 · Mayer Laboratories · Nov 1995
KIMONO (CONDOMS)
K943064 · Mayer Laboratories · Sep 1995
MAXX
K946376 · Mayer Laboratories · Sep 1995