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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
469d slower than avg
Panel avg: 161d · 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 396
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K941258.
SEMINAL FLUID COLLECTION KIT II
K954791 · Apex Medical Technologies, Inc. · Jan 1996
SPERMICIDALLY LUBRICATED CONDOM
K940047 · Ansell, Inc. · Dec 1995
RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE
K945930 · Line One Laboratories & Trading Co. · Dec 1995
RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORANGE, PURPLE AND BLACK)
K944786 · Line One Laboratories & Trading Co. · Dec 1995
PROBE PERSONAL LUBRICANT - CLASSIC
K952464 · Davryan Laboratories, Inc. · Nov 1995
PROBE PERSONAL LUBRICANT - SILKY LIGHT
K952465 · Davryan Laboratories, Inc. · Nov 1995
K941258 · LATEX CONDOM
Download PDF Suretex, Ltd.