Olympus,Jasmine,Jimmy-O Raincoat,Drink,Ares,Aphrodite,Zeus,Apollo,Selfcare,Careplus,Titan
FDA 510(k) K963321 · Custom Services Intl., Inc.
510(k) numberK963321
Submission
- Device name
- Olympus,Jasmine,Jimmy-O Raincoat,Drink,Ares,Aphrodite,Zeus,Apollo,Selfcare,Careplus,Titan
- Applicant
- Custom Services Intl., Inc.
Las Vegas, NV, US - Received
- August 12, 1996
- Decision date
- January 22, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HIS – Condom
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252622 | Male Latex Condom HAHIS · Abbreviated | Okamoto USA, Inc. | 05/04/2026SE |
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex CondomHIS · Abbreviated | Suretex Limited | 11/18/2025SE |
| K250034 | Natural rubber latex male condomHIS · Traditional | Shaoguan Regenex Pharmaceuticals Co., Ltd. | 07/11/2025SE |
| K243421 | Lelo Hex Lubricated Natural Rubber Latex CondomHIS · Traditional | Lelo, Inc. | 03/07/2025SE |
| K243640 | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)HIS · Traditional | Church & Dwight Co., Inc. | 02/21/2025SE |
| K243584 | 0.04 ZERO ZERO FOUR Male Latex CondomHIS · Abbreviated | Okamoto USA, Inc. | 02/18/2025SE |
| K232279 | LifeStyles NRL Textured CondomHIS · Abbreviated | Suretex Limited | 10/05/2023SE |
| K230049 | SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots…HIS · Traditional | Ttk Healthcare Limited | 09/07/2023SE |
| K222611 | Male Latex CondomsHIS · Traditional | Suzhou Colour-Way New Material Co., Ltd. | 11/28/2022SE |
| K220489 | Durex Patronus CloseFit, Durex Patronus RegularHIS · Traditional | Rb Health (Us), LLC | 11/07/2022SE |
More from Rb Health (Us), LLC
| 510(k) | Device | Decision |
|---|---|---|
| K972430 | Extrawear, Gentlemen's Choice W/NONOXYNOL-9LTZ · Traditional | 09/10/1997SE |
| K972429 | Innerwear, Gentlemen's Choice W/NONOXYNOL-9LTZ · Traditional | 09/10/1997SE |
| K972428 | Extrawear, Gentlemen's ChoiceHIS · Traditional | 08/25/1997SE |
| K972427 | Innerwear, Jimmy-O Raincoat, Raincoat, Jasmine, DrinkHIS · Traditional | 08/20/1997SE |
| K970791 | Innerwear/Extrawear/Jimmy-O Raincoat/Zeus/Gentlemen's Choice/Jasmine/Drink/NaughtyLTZ · Traditional | 06/03/1997SE |
| K970767 | Condom (Rubber), Lubricated, Extra StrengthHIS · Traditional | 06/02/1997SE |
| K963322 | Olympus,Jasmine,Jimmy-O Raincoat,Drink,Ares,Aphrodite,Zeus,Apollo,Selfcare,Careplus,TitanLTZ · Traditional | 01/22/1997SE |
| K963319 | Olympus,Jasmine,Jimmy-O Raincoat,Drink,Ares,Aphrodit,Zeus,Apollo,Selfcare,Careplus,TitanHIS · Traditional | 01/22/1997SE |
Questions and answers
When was Olympus,Jasmine,Jimmy-O Raincoat,Drink,Ares,Aphrodite,Zeus,Apollo,Selfcare,Careplus,Titan cleared by the FDA?
Olympus,Jasmine,Jimmy-O Raincoat,Drink,Ares,Aphrodite,Zeus,Apollo,Selfcare,Careplus,Titan (K963321) received a 510(k) decision of Substantially Equivalent on January 22, 1997, 163 days after the submission was received.
What is the product code of K963321?
The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.