Cleared Traditional

Playboy 3 Contour Condom (K211450) - FDA 510(k) Clearance

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

K211450 · Thai Nippon Rubber Industry Public Company Limited. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
143d
Days
Class 2
Risk

K211450 is an FDA 510(k) clearance for the Playboy 3 Contour Condom. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Thai Nippon Rubber Industry Public Company Limited. (Sriracha, TH). The FDA issued a Cleared decision on September 30, 2021 after a review of 143 days - within the typical 510(k) review window.

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 Thai Nippon Rubber Industry Public Company Limited. devices

Submission Details

510(k) Number K211450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2021
Decision Date September 30, 2021
Days to Decision 143 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
17d faster than avg
Panel avg: 160d · This submission: 143d
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.

Regulatory Consultant

Regulatory Insight, Inc.
Kevin Walls

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HIS Condom

All 29
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K211450.
Titan Condoms
K210208 · Titan Condoms, LLC · Feb 2022
Durex Patronus Wide
K213647 · Rb Health (Us), LLC · Feb 2022
SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla
K213547 · Ttk Healthcare Limited · Dec 2021
One Touch Spiral Condom
K210294 · Thai Nippon Rubber Industry Public Company Limited. · Sep 2021
Male Latex Condom
K203536 · Global Protection Corp. · Sep 2021
SKORE (Colors & Flavors), SKORE (Colors)
K202403 · Ttk Healthcare Limited · Apr 2021