Cleared Traditional

K871948 - ANGEL LATEX PROPHYLACTICS (CONDOMS)

K871948 is the FDA 510(k) clearance for ANGEL LATEX PROPHYLACTICS (CONDOMS) by Angel Intl. Trading Co., Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIS) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K871948 · Angel Intl. Trading Co., Inc. · Obstetrics & Gynecology device
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Oct 1987
Decision
153d
Days
Class 2
Risk

K871948 is an FDA 510(k) clearance for the ANGEL LATEX PROPHYLACTICS (CONDOMS). Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Angel Intl. Trading Co., Inc. (Cameron, US). The FDA issued a Cleared decision on October 20, 1987 after a review of 153 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Angel Intl. Trading Co., Inc. devices

Submission Details

510(k) Number K871948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1987
Decision Date October 20, 1987
Days to Decision 153 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 160d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.