510(k) K070800
- Device
- LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM
- Applicant
- ANSELL HEALTHCARE PRODUCTS LLC
- 510(k) number
- K070800
- Product code
- MOL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-03-06
- Date received
- 2007-03-23
- Regulation
- 884.5300
- Classification name
- Condom, Synthetic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LON D MCILVAIN
- Address
- 1635 Industrial Rd. Dothan AL US 36303 36303
FDA Registration Numbers#
- 2938651
- 1222115
- 3003592318
- 3006122980
- 3011015568
- 3013770781
- 2086832
- 2531449
- 3003491851
- 3007829481
- 9613932
- 9680135
- 2280705
- 8040641
- 1000136042
- 1122329
- 3003071219
Source Documents#
Other 510(k) Records For Product Code MOL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male Condom | Mayer Laboratories | 2026-03-30 |
| K243967 | ONE Nitrile Condom | Global Protection Corp. | 2025-04-08 |
| K241617 | Durex Polyisoprene Condom | Rb Health (Us), LLC | 2025-02-28 |
| K240379 | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | Church & Dwight Co., Inc. | 2024-10-08 |
| K240896 | ONE Nitrile Condom | Global Protection Corp. | 2024-08-23 |
| K232470 | Polyisoprene Extra Large Condom | Suretex Limited | 2024-05-09 |
| K231908 | 45 Micron Polyisoprene Condom | Suretex Limited | 2023-10-27 |
| K203541 | Okamoto 002 Lubricated Polyurethane Male Condom | Okamoto USA, Inc. | 2022-02-25 |
| K182438 | Synthetic Polyisoprene Lubricated Male Condom - 5 senses | Sxwell USA, LLC | 2018-12-06 |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored | Ansell Healthcare Products, LLC | 2017-08-02 |
| K171639 | Trojan Supra Lubricated Polyurethane Male Condom | Church & Dwight Co., Inc. | 2017-08-01 |
| K160399 | Skyn Original Polyisoprene Lubricated Male Condom | Ansell Healthcare Products, LLC | 2016-07-25 |
| K100767 | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM | Church & Dwight Co., Inc. | 2011-04-05 |
| K072169 | DUREX SYNTHETIC POLYISOPRENE MALE CONDOM | Ssl Americas, Inc. | 2008-06-19 |
| K050828 | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM | Church & Dwight Co., Inc. | 2006-02-28 |
Legacy Summary#
summary
FDA Review#
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