Cleared Traditional

K982380 - SURE

K982380 is an FDA 510(k) clearance for SURE, manufactured by Pleasure Latex Products Sdn. Bhd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K982380 · Pleasure Latex Products Sdn. Bhd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K982380

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
Combination Product No
PCCP Authorized No
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.

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 109
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K982380.
LIFESTYLES XTRA PLEASURE
K983518 · Ansell, Inc. · Jul 1999
CVS PERSONAL LUBRICANT
K983216 · San-Mar Laboratories, Inc. · May 1999
MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS
K980964 · Ls Rubber Sdn Bhd · Mar 1999
SHEER THIN
K984488 · Twe Companies, Inc. · Feb 1999
OASIS
K984218 · Glimex Corp. · Dec 1998
ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS
K983320 · Suretex Prophylactics (India) , Ltd. · Dec 1998