Cleared Traditional

K982380 - SURE (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K982380 · Pleasure Latex Products Sdn. Bhd. · Obstetrics & Gynecology device
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Feb 1999
Decision
233d
Days
Class 2
Risk

K982380 is an FDA 510(k) clearance for the SURE. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Pleasure Latex Products Sdn. Bhd. (Jeram, Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on February 26, 1999 after a review of 233 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 Pleasure Latex Products Sdn. Bhd. devices

Submission Details

510(k) Number K982380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1998
Decision Date February 26, 1999
Days to Decision 233 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 160d · This submission: 233d
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.

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