Male Latex Condom with Vanilla Flavor
FDA 510(k) K994311 · Pleasure Latex Products Sdn. Bhd.
510(k) numberK994311
Submission
- Device name
- Male Latex Condom with Vanilla Flavor
- Applicant
- Pleasure Latex Products Sdn. Bhd.
Jeram, Selangor Darul Ehsan, MY - Received
- December 22, 1999
- Decision date
- March 21, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|
| K022156 | Latex Ultrasonic Probe CoverITX · Abbreviated | 09/11/2003SE |
| K023333 | Multiple, Male Latex Condom [52MM or 56MM Nominal Width with Smooth or Dotted or Ribbed…HIS · Abbreviated | 06/23/2003SE |
| K021875 | Male Latex Condom with Dotted/Ribbed Surface and Counour-Walled Shape (3 in 1 Ultimate…HIS · Abbreviated | 09/05/2002SE |
| K020272 | Male Latex Condom with Ribbed SurfaceHIS · Abbreviated | 04/26/2002SE |
| K002571 | Mulitple Male Latx CondomHIS · Abbreviated | 11/16/2000SE |
| K001377 | Spermicidal Lubricated Male Latex CondomLTZ · Abbreviated | 06/08/2000SE |
| K001221 | Male Latex Comdom with Dotted SurfaceHIS · Abbreviated | 05/19/2000SE |
| K994312 | Male Latex Condom 56MMHIS · Abbreviated | 03/21/2000SE |
| K982380 | SureHIS · Traditional | 02/26/1999SE |
Questions and answers
When was Male Latex Condom with Vanilla Flavor cleared by the FDA?
Male Latex Condom with Vanilla Flavor (K994311) received a 510(k) decision of Substantially Equivalent on March 21, 2000, 90 days after the submission was received.
What is the product code of K994311?
The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.