Product code HIS
- Device name
- Condom
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.5300
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252622 | Male Latex Condom HA | Okamoto USA, Inc. | 2026-05-04 |
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom | Suretex Limited | 2025-11-18 |
| K250034 | Natural rubber latex male condom | Shaoguan Regenex Pharmaceuticals Co., Ltd. | 2025-07-11 |
| K243421 | Lelo Hex Lubricated Natural Rubber Latex Condom | Lelo, Inc. | 2025-03-07 |
| K243640 | Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) | Church & Dwight Co., Inc. | 2025-02-21 |
| K243584 | 0.04 ZERO ZERO FOUR Male Latex Condom | Okamoto USA, Inc. | 2025-02-18 |
| K232279 | LifeStyles NRL Textured Condom | Suretex Limited | 2023-10-05 |
| K230049 | 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 Condom... | Ttk Healthcare Limited | 2023-09-07 |
| K222611 | Male Latex Condoms | Suzhou Colour-Way New Material Co., Ltd. | 2022-11-28 |
| K220489 | Durex Patronus CloseFit, Durex Patronus Regular | Rb Health (Us), LLC | 2022-11-07 |
| K222068 | Durex Penck III Regular | Rb Health (Us), LLC | 2022-10-12 |
| K221906 | TROJAN Fire & Ice lubricated male natural rubber latex condom | Church & Dwight Co., Inc. | 2022-09-28 |
| K220576 | FAMA Male Latex Condoms | Shanghai Personage Hygiene Products Co., Ltd. | 2022-08-05 |
| K221431 | TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant | Church & Dwight Co., Inc. | 2022-07-14 |
| K211152 | Durex Condom with Benzocaine | Rb Health (Us), LLC | 2022-05-11 |
| K213921 | Microthin Natural Rubber Latex Condom | Suretex Limited | 2022-04-28 |
| K213647 | Durex Patronus Wide | Rb Health (Us), LLC | 2022-02-17 |
| K210208 | Titan Condoms | Titan Condoms, LLC | 2022-02-17 |
| K213547 | SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla | Ttk Healthcare Limited | 2021-12-23 |
| K211450 | Playboy 3 Contour Condom | Thai Nippon Rubber Industry Public Company Limited. | 2021-09-30 |
| K210294 | One Touch Spiral Condom | Thai Nippon Rubber Industry Public Company Limited. | 2021-09-23 |
| K203536 | Male Latex Condom | Global Protection Corp. | 2021-09-03 |
| K202403 | SKORE (Colors & Flavors), SKORE (Colors) | Ttk Healthcare Limited | 2021-04-15 |
| K200672 | Durex Penck Standard, Durex Penck XL | Rb Health (Us), LLC | 2020-11-06 |
| K193578 | Non-spermicidal Lubricated Male Latex Condom | Global Protection Corp. | 2020-08-20 |
| K201067 | CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed)) | Cupid Limited | 2020-08-07 |
| K192669 | Extremely Thin 003, ZERO ZERO THREE | Okamoto USA, Inc. | 2020-07-24 |
| K181844 | One Touch | Thai Nippon Rubber Industry Public Company, Ltd. | 2019-04-15 |
| K180104 | Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant | Church & Dwight Co., Inc. | 2018-03-14 |
| K171213 | One Touch Condom with Benzocaine | Thai Nippon Rubber Industry Public Company Limited. | 2018-01-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08859798101008 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-27 |
| 08859798100995 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-27 |
| 08859798100988 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-25 |
| 08859798100971 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-25 |
| 08859798100964 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-25 |
| 08859798100957 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-25 |
| 08859798100506 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-18 |
| 08859798100582 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-18 |
| 08859798100575 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-18 |
| 08859798100568 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-18 |
| 08859798100551 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-18 |
| 08859798100544 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-18 |
| 08859798100537 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-18 |
| 08859798100520 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-18 |
| 08859798100513 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-18 |
| 08859798100490 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-18 |
| 08859798100483 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-18 |
| 08859798100476 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-18 |
| 08859798100469 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-18 |
| 08859798100308 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100292 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100285 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100117 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100100 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100094 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100087 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100070 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08859798100063 | LIFESTYLES | SURETEX LIMITED - BRANCH | 2023-09-14 |
| 08802550012111 | UNIDUS LONG LOVE 3PCS | BioGenetics CO.,LTD. | 2017-01-20 |
| 08802550012227 | UNIDUS LONG LOVE Gross Case | BioGenetics CO.,LTD. | 2017-01-20 |