Cleared Abbreviated

K993887 - ALATECH LATEX CONDOM

K993887 is an FDA 510(k) clearance for ALATECH LATEX CONDOM, manufactured by Alatech Healthcare, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 34-day FDA review.

K993887 · Alatech Healthcare, LLC · Obstetrics & Gynecology device
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Dec 1999
Decision
34d
Days
Class 2
Risk

K993887 is an FDA 510(k) clearance for the ALATECH LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Alatech Healthcare, LLC (Slocomb, US). The FDA issued a Cleared decision on December 20, 1999 after a review of 34 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Alatech Healthcare, LLC devices

FDA 510(k) Submission Details - K993887

510(k) Number K993887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1999
Decision Date December 20, 1999
Days to Decision 34 days
Submission Type Abbreviated
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
127d faster than avg
Panel avg: 161d · This submission: 34d
Pathway characteristics
Standards-based clearance path.

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 252
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K993887.
SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9)
K993782 · P.T. Vonix Latexindo Condom (Rubber) Mfg. · Feb 2000
LATEX CONDOM
K994095 · Thai Nippon Rubber Industry Co., Ltd. · Jan 2000
INVIGRA
K993693 · Indus Medicare , Ltd. · Dec 1999
TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR
K991892 · Line One Laboratories · Aug 1999
VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL
K992081 · Suretex Prophylactics (India) , Ltd. · Aug 1999
ANSELL CONDOMS
K984392 · Ansell, Inc. · Jul 1999