Black Coloured Condom
FDA 510(k) K132597 · Karex Industries Sdn. Bhd.
510(k) numberK132597
Submission
- Device name
- Black Coloured Condom
- Applicant
- Karex Industries Sdn. Bhd.
Pontian Kecil, Jalan Johor, MY - Received
- August 19, 2013
- Decision date
- November 25, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K252622 | Male Latex Condom HAHIS · Abbreviated | Okamoto USA, Inc. | 05/04/2026SE |
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex CondomHIS · Abbreviated | Suretex Limited | 11/18/2025SE |
| K250034 | Natural rubber latex male condomHIS · Traditional | Shaoguan Regenex Pharmaceuticals Co., Ltd. | 07/11/2025SE |
| K243421 | Lelo Hex Lubricated Natural Rubber Latex CondomHIS · Traditional | Lelo, Inc. | 03/07/2025SE |
| K243640 | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)HIS · Traditional | Church & Dwight Co., Inc. | 02/21/2025SE |
| K243584 | 0.04 ZERO ZERO FOUR Male Latex CondomHIS · Abbreviated | Okamoto USA, Inc. | 02/18/2025SE |
| K232279 | LifeStyles NRL Textured CondomHIS · Abbreviated | Suretex Limited | 10/05/2023SE |
| K230049 | SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots…HIS · Traditional | Ttk Healthcare Limited | 09/07/2023SE |
| K222611 | Male Latex CondomsHIS · Traditional | Suzhou Colour-Way New Material Co., Ltd. | 11/28/2022SE |
| K220489 | Durex Patronus CloseFit, Durex Patronus RegularHIS · Traditional | Rb Health (Us), LLC | 11/07/2022SE |
More from Rb Health (Us), LLC
| 510(k) | Device | Decision |
|---|---|---|
| K223519 | Carex Hybrid Personal LubricantNUC · Abbreviated | 08/11/2023SE |
| K150743 | Water Based Personal Lubricant with FlavoursNUC · Abbreviated | 11/12/2015SE |
| K141059 | Natural Rubber Latex Male CondomsHIS · Abbreviated | 08/01/2014SE |
| K113056 | Orange Colored Condoms Orange ScentHIS · Special | 07/03/2012SE |
| K113061 | Large/Extra Lagre CondomHIS · Special | 12/07/2011SE |
| K081886 | Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated and Non…HIS · Abbreviated | 02/06/2009SE |
| K070830 | Male Natural Rubber Latex Condom (with Coloring and Flavoring)HIS · Abbreviated | 05/08/2007SE |
Questions and answers
When was Black Coloured Condom cleared by the FDA?
Black Coloured Condom (K132597) received a 510(k) decision of Substantially Equivalent on November 25, 2013, 98 days after the submission was received.
What is the product code of K132597?
The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.