Cleared Traditional

K864570 - PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME

K864570 is an FDA 510(k) clearance for PAMITEX, manufactured by Dongkuk Techco Rubber Industries. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K864570 · Dongkuk Techco Rubber Industries · Obstetrics & Gynecology device
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Dec 1986
Decision
40d
Days
Class 2
Risk

K864570 is an FDA 510(k) clearance for the PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Dongkuk Techco Rubber Industries (Beverly Hills, US). The FDA issued a Cleared decision on December 30, 1986 after a review of 40 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 - K864570

510(k) Number K864570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1986
Decision Date December 30, 1986
Days to Decision 40 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
121d faster than avg
Panel avg: 161d · This submission: 40d
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 K864570.
PROPHYLACTIC (CONDOM) MR. JOHNNY
K865106 · Medelec Intl. Corp. · May 1987
PERSONAL/DERBY CONDOMS
K862401 · Razi Corp. · Mar 1987
EXTRA STRONG CONDOM
K864400 · Ansell, Inc. · Feb 1987
CHOICE
K864482 · Select Sources, Inc. · Dec 1986
CHOICE CONDOM
K863190 · Select Sources, Inc. · Dec 1986
SEMINAL FLUID COLLECTION KIT(TM)
K864473 · Apex Technologies, Inc. · Dec 1986
K864570 · PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME
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