Love Lockers
FDA 510(k) K993733 · Medtech Products , Ltd.
510(k) numberK993733
Submission
- Device name
- Love Lockers
- Applicant
- Medtech Products , Ltd.
Chennai, IN - Received
- November 4, 1999
- Decision date
- March 20, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary 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 |
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| K242803 | Compound W Skin Tag RemoverGEH · Traditional | 11/06/2024SE |
| K202974 | DenTek Fresh Protect Dental GuardOBR · Traditional | 12/22/2020SE |
| K180933 | DenTek Ultimate Dental GuardOBR · Traditional | 09/17/2018SE |
| K172373 | Compound W Nitro-FreezeGEH · Traditional | 11/02/2017SE |
| K163401 | Nix Ultra Lice Treatment KitLJL · Traditional | 03/21/2017SE |
| K161294 | Compound W Wart Removal System Dual PowerGEH · Traditional | 09/15/2016SE |
| K063401 | Banana RibbedHIS · Abbreviated | 03/26/2007SE |
| K012969 | Double Springers Nonoxnol 9 CondomLTZ · Abbreviated | 06/12/2002SE |
| K993737 | Mighty Man (Dynamic Linkers)HIS · Abbreviated | 03/20/2000SE |
| K993735 | Double SpringersHIS · Abbreviated | 03/20/2000SE |
Questions and answers
When was Love Lockers cleared by the FDA?
Love Lockers (K993733) received a 510(k) decision of Substantially Equivalent on March 20, 2000, 137 days after the submission was received.
What is the product code of K993733?
The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.