Cleared Traditional

K211450 - Playboy 3 Contour Condom

K211450 is an FDA 510(k) clearance for Playboy 3 Contour Condom, manufactured by Thai Nippon Rubber Industry Public Company Limited.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 143-day FDA review.

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

FDA 510(k) Submission Details - K211450

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.

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 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 59
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