Cleared Traditional

K822792 - NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT

K822792 is an FDA 510(k) clearance for NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT, manufactured by Ansell, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K822792 · Ansell, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Sep 1982
Decision
15d
Days
Class 2
Risk

K822792 is an FDA 510(k) clearance for the NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Ansell, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 30, 1982 after a review of 15 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K822792

510(k) Number K822792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1982
Decision Date September 30, 1982
Days to Decision 15 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d faster than avg
Panel avg: 161d · This submission: 15d
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 401
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K822792.
PRIME
K830691 · Ansell, Inc. · Mar 1983
SEMINAL COLLECTION DEVICE
K823937 · Health Development Corp. · Feb 1983
MALE CONDOM
K822088 · Schmid Laboratories, Inc. · Nov 1982
WORLD'S BEST (CONTRACEPTIVE)
K820564 · Rosen Kilde Stenhoj · May 1982
CONDOM-MULTIPAL STYLES
K813172 · Circle Rubber Corp. · Mar 1982
UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA,
K800518 · Kopharm, Inc. · Mar 1980
K822792 · NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT
Download PDF Ansell, Inc.