FLAVORED MALE LATEX CONDOM
FDA 510(k) clearance K011253 · decided 2001-07-20
Clearance details
- K-number
- K011253
- Device name
- FLAVORED MALE LATEX CONDOM
- Applicant
- Thai Nippon Rubber Industry Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-24
- Decision date
- 2001-07-20
- Days to decision
- 87 days
- Clearance type
- Abbreviated
- Product code
- HIS
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Male Latex Condom HA (K252622) | Okamoto USA, Inc. | 2026-05-04 |
| LifeStyles® HydraFeel Natural Rubber Latex Condom (K252521) | Suretex Limited | 2025-11-18 |
| Natural rubber latex male condom (K250034) | Shaoguan Regenex Pharmaceuticals Co., Ltd. | 2025-07-11 |
| Lelo Hex Lubricated Natural Rubber Latex Condom (K243421) | Lelo, Inc. | 2025-03-07 |
| Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) (K243640) | Church & Dwight Co., Inc. | 2025-02-21 |
| 0.04 ZERO ZERO FOUR Male Latex Condom (K243584) | Okamoto USA, Inc. | 2025-02-18 |
| LifeStyles NRL Textured Condom (K232279) | Suretex Limited | 2023-10-05 |
| 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) | Ttk Healthcare Limited | 2023-09-07 |
| Male Latex Condoms (K222611) | Suzhou Colour-Way New Material Co., Ltd. | 2022-11-28 |
| Durex Patronus CloseFit, Durex Patronus Regular (K220489) | Rb Health (Us), LLC | 2022-11-07 |
| Durex Penck III Regular (K222068) | Rb Health (Us), LLC | 2022-10-12 |
| TROJAN Fire & Ice lubricated male natural rubber latex condom (K221906) | Church & Dwight Co., Inc. | 2022-09-28 |
Recalls involving this device
No recalls on record reference this clearance.