ONE Nitrile Condom
FDA 510(k) K243967 · Global Protection Corp.
510(k) numberK243967
Submission
- Device name
- ONE Nitrile Condom
- Applicant
- Global Protection Corp.
Boston, MA, US - Received
- December 23, 2024
- Decision date
- April 8, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MOL – Condom, Synthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male CondomMOL · Traditional | Mayer Laboratories | 03/30/2026SE |
| K241617 | Durex Polyisoprene CondomMOL · Traditional | Rb Health (Us), LLC | 02/28/2025SE |
| K240379 | TROJAN SIS Synthetic Latex Condom with Silicone LubricantMOL · Traditional | Church & Dwight Co., Inc. | 10/08/2024SE |
| K240896 | ONE Nitrile CondomMOL · Traditional | Global Protection Corp. | 08/23/2024SE |
| K232470 | Polyisoprene Extra Large CondomMOL · Abbreviated | Suretex Limited | 05/09/2024SE |
| K231908 | 45 Micron Polyisoprene CondomMOL · Traditional | Suretex Limited | 10/27/2023SE |
| K203541 | Okamoto 002 Lubricated Polyurethane Male CondomMOL · Traditional | Okamoto USA, Inc. | 02/25/2022SE |
| K182438 | Synthetic Polyisoprene Lubricated Male Condom - 5 sensesMOL · Abbreviated | Sxwell USA, LLC | 12/06/2018SE |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - FlavoredMOL · Abbreviated | Ansell Healthcare Products, LLC | 08/02/2017SE |
| K171639 | Trojan Supra Lubricated Polyurethane Male CondomMOL · Traditional | Church & Dwight Co., Inc. | 08/01/2017SE |
More from Church & Dwight Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250142 | Water-based LubricantNUC · Traditional | 08/08/2025SE |
| K243972 | Plain Water-based LubricantNUC · Traditional | 08/08/2025SE |
| K240896 | ONE Nitrile CondomMOL · Traditional | 08/23/2024SE |
| K223214 | Powder-Free Nitrile Examination GlovesLZA · Abbreviated | 09/21/2023SE |
| K213087 | Natural Rubber Latex Ultrasound Transducer Probe CoversITX · Traditional | 06/07/2022SE |
| K203536 | Male Latex CondomHIS · Abbreviated | 09/03/2021SE |
| K193578 | Non-spermicidal Lubricated Male Latex CondomHIS · Abbreviated | 08/20/2020SE |
| K024324 | Latex Condom and Latex Condom Lubricated with NONOXYNOL-9HIS · Abbreviated | 03/25/2003SE |
| K960552 | Knight Light Nonlubricated CondomHIS · Traditional | 11/20/1997SE |
Questions and answers
When was ONE Nitrile Condom cleared by the FDA?
ONE Nitrile Condom (K243967) received a 510(k) decision of Substantially Equivalent on April 8, 2025, 106 days after the submission was received.
What is the product code of K243967?
The FDA product code is MOL – Condom, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 884.5300.