SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT

FDA 510(k) K230049 · Ttk Healthcare Limited

Substantially Equivalent

510(k) numberK230049

Submission

Device name
SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT
Applicant
Ttk Healthcare Limited
Puducherry, IN
Received
January 6, 2023
Decision date
September 7, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HIS – Condom
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5300
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HIS

510(k)DeviceApplicantDecision
K252622Male Latex Condom HAHIS · Abbreviated Okamoto USA, Inc.05/04/2026SE
K252521LifeStyles® HydraFeel Natural Rubber Latex CondomHIS · Abbreviated Suretex Limited11/18/2025SE
K250034Natural rubber latex male condomHIS · Traditional Shaoguan Regenex Pharmaceuticals Co., Ltd.07/11/2025SE
K243421Lelo Hex Lubricated Natural Rubber Latex CondomHIS · Traditional Lelo, Inc.03/07/2025SE
K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)HIS · Traditional Church & Dwight Co., Inc.02/21/2025SE
K2435840.04 ZERO ZERO FOUR Male Latex CondomHIS · Abbreviated Okamoto USA, Inc.02/18/2025SE
K232279LifeStyles NRL Textured CondomHIS · Abbreviated Suretex Limited10/05/2023SE
K222611Male Latex CondomsHIS · Traditional Suzhou Colour-Way New Material Co., Ltd.11/28/2022SE
K220489Durex Patronus CloseFit, Durex Patronus RegularHIS · Traditional Rb Health (Us), LLC11/07/2022SE
K222068Durex Penck III RegularHIS · Traditional Rb Health (Us), LLC10/12/2022SE

More from Rb Health (Us), LLC

510(k)DeviceDecision
K213547SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE VanillaHIS · Special 12/23/2021SE
K202403SKORE (Colors & Flavors), SKORE (Colors)HIS · Traditional 04/15/2021SE
K012067Clincare Latex Surgeon's GloveKGO · Traditional 09/17/2001SE

Questions and answers

When was SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT cleared by the FDA?

SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT (K230049) received a 510(k) decision of Substantially Equivalent on September 7, 2023, 244 days after the submission was received.

What is the product code of K230049?

The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.