Skyn Original Polyisoprene Lubricated Male Condom - Flavored
FDA 510(k) K171172 · Ansell Healthcare Products, LLC
510(k) numberK171172
Submission
- Device name
- Skyn Original Polyisoprene Lubricated Male Condom - Flavored
- Applicant
- Ansell Healthcare Products, LLC
Iselin, NJ, US - Received
- April 21, 2017
- Decision date
- August 2, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male CondomMOL · Traditional | Mayer Laboratories | 03/30/2026SE |
| K243967 | ONE Nitrile CondomMOL · Traditional | Global Protection Corp. | 04/08/2025SE |
| 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 |
| 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 |
|---|---|---|
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis…KGO · Traditional | 08/23/2023SE |
| K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy DrugsKGO · Traditional | 05/26/2023SE |
| K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with…LZA · Traditional | 03/10/2022SE |
| K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with…LZA · Traditional | 06/13/2021SE |
| K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink…LZA · Traditional | 06/19/2020SE |
| K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy…KGO · Traditional | 05/23/2019SE |
| K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy DrugsKGO · Traditional | 03/22/2019SE |
| K171375 | Gammex PI Breach Detect Powder Free Surgical GloveKGO · Traditional | 02/06/2018SE |
| K171737 | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination GlovesLZA · Traditional | 12/29/2017SE |
| K163107 | Lifestyles Zero Lubricated Latex Male CondomHIS · Abbreviated | 01/23/2017SE |
Questions and answers
When was Skyn Original Polyisoprene Lubricated Male Condom - Flavored cleared by the FDA?
Skyn Original Polyisoprene Lubricated Male Condom - Flavored (K171172) received a 510(k) decision of Substantially Equivalent on August 2, 2017, 103 days after the submission was received.
What is the product code of K171172?
The FDA product code is MOL – Condom, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 884.5300.