Cleared Traditional

K943880 - RIA LATEX CONDOM

K943880 is an FDA 510(k) clearance for RIA LATEX CONDOM, manufactured by Mbf Personal Care Sdn. Bhd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 553-day FDA review.

K943880 · Mbf Personal Care Sdn. Bhd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
553d
Days
Class 2
Risk

K943880 is an FDA 510(k) clearance for the RIA LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Mbf Personal Care Sdn. Bhd. (Senai, Johor, MY). The FDA issued a Cleared decision on February 13, 1996 after a review of 553 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 Mbf Personal Care Sdn. Bhd. devices

FDA 510(k) Submission Details - K943880

510(k) Number K943880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1994
Decision Date February 13, 1996
Days to Decision 553 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
393d slower than avg
Panel avg: 160d · This submission: 553d
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 146
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K943880.
TRUSTEX FLAVOR CONDON IN COLORS
K946103 · Line One Laboratories & Trading Co. · Jul 1996
K-Y PERSONAL LUBRICANT
K955648 · Ortho Pharmaceutical Corp. · Jun 1996
RIA LATEX CONDOM, NONOXYNOL-9
K945145 · Mbf Personal Care Sdn. Bhd. · Feb 1996
LUBRICATED CONDOM
K953583 · Tactyl Technologies, Inc. · Jan 1996
CONQUEROR, RUMBA AND TEMPTATION
K946207 · Frontline Latex Products Pvt. , Ltd. · Jan 1996
SEMINAL FLUID COLLECTION KIT II
K954791 · Apex Medical Technologies, Inc. · Jan 1996