Cleared Traditional

K896987 - RUBBER CONDOM (NON-COLORED)

K896987 is an FDA 510(k) clearance for RUBBER CONDOM (NON-COLORED), manufactured by Hankook Latex Gongup Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K896987 · Hankook Latex Gongup Co., Ltd. · Obstetrics & Gynecology device
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Jun 1990
Decision
175d
Days
Class 2
Risk

K896987 is an FDA 510(k) clearance for the RUBBER CONDOM (NON-COLORED). Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Hankook Latex Gongup Co., Ltd. (Seoul, Korea, KR). The FDA issued a Cleared decision on June 6, 1990 after a review of 175 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.

FDA 510(k) Submission Details - K896987

510(k) Number K896987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1989
Decision Date June 06, 1990
Days to Decision 175 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
14d slower than avg
Panel avg: 161d · This submission: 175d
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 401
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K896987.
TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
K901202 · Carter Products · Jun 1990
MINT SCENTED CONDOMS
K900679 · Schmid Laboratories, Inc. · Jun 1990
RUBBER CONTRACEPTIVE (CONDOM)
K896142 · Guangzhou No. 11 Rubber Factory · Jun 1990
CONDOM (RUBBER) CONTRACEPTIVE
K901416 · Aladan Corp. · Jun 1990
CONDOMS (MULTIPLE BRANDS)
K897129 · Sagami, Inc. · May 1990
LATEX CONDOMS - CODE NO. 401, 421 & 1002
K901667 · Allercare/Nsl, Inc. · May 1990
K896987 · RUBBER CONDOM (NON-COLORED)
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