Cleared Traditional

K895530 - STANDARD CONDOM

K895530 is an FDA 510(k) clearance for STANDARD CONDOM, manufactured by Mayer Laboratories. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K895530 · Mayer Laboratories · Obstetrics & Gynecology device
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Nov 1989
Decision
76d
Days
Class 2
Risk

K895530 is an FDA 510(k) clearance for the STANDARD CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Mayer Laboratories (Oakland, US). The FDA issued a Cleared decision on November 28, 1989 after a review of 76 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 - K895530

510(k) Number K895530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1989
Decision Date November 28, 1989
Days to Decision 76 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
85d faster than avg
Panel avg: 161d · This submission: 76d
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 294
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K895530.
CONDOM (RUBBER LATEX) OKEIDO
K894534 · Rfsu · Dec 1989
BIRDS'N BEES CONDOMS
K895028 · Rfsu · Dec 1989
PROFIL CONDOM (RUBBER LATEX)
K895894 · Rfsu · Dec 1989
HSV-CHECK(TM) TEST KIT
K890819 · Diagnostic Technology, Inc. · Jun 1989
TROJAN FOR WOMEN
K890863 · Armkel, LLC · Apr 1989
TROJAN EXTRA STRENGTH LUBRICATED
K883413 · Carter Products · Dec 1988
K895530 · STANDARD CONDOM
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