004® Zero Zero Four® Condoms
5 catalogue numbers from 04024, listed by Okamoto USA, Inc., United States, under Condom. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
5catalogue numbers in this listing
14510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Armocon Technology Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 5 |
| Dalian Latex Co Ltd | Dalian | Liaoning | Contract manufacturer | 1 |
| Rfx+care Manufacturing Co., Ltd. | Shaoxing | Zhejiang | Repacker / relabeller | 21 |
| Suzhou Colour-way New Material Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
| Shanghai Jinxiang Latex Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 3 |
| Shanghai Personage Hygiene Products Co., Ltd. | Shanghai | Shanghai | Manufacturer | 1 |
| Guangzhou Double One Latex Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 1 |
| Qingdao London Durex Co., Ltd. | Qingdao | Shandong | Manufacturer | 1 |
| Shaoguan Regenex Pharmaceutical Co., Ltd. | Shaoguan | Guangdong | Manufacturer | 1 |
Record
| Listed by | Okamoto USA, Inc., United States |
|---|---|
| FDA product code | HIS |
| Device type | Condom |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5300 |
| Record published | 2018-12-07 |
| Record revised | 2024-09-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Shipper of 24, shipper of 288, shipper of 192, shipper of 48 |
| Distribution end date | 2023-09-11 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 04024 | 24 | In distribution | |
| 04036 | 36 | Withdrawn | |
| 04001 | Withdrawn | ||
| 04003 | 3 | Withdrawn | |
| 04010 | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lifestyles | Suretex Limited – Branch | 158 |
| Custom Condoms | Global Protection Corp. | 94 |
| My One | Global Protection Corp. | 51 |
| ONE | Global Protection Corp. | 45 |
| Keypers | Global Protection Corp. | 38 |
| Handy Solutions | Navajo Manufacturing Company | 35 |
| Royal | M3 Global Enterprises, LLC | 26 |
| b condoms | B Holding Group LLC | 22 |
| ONE | Lunamax LLC | 20 |
| Kimono | Mayer Laboratories | 20 |
| Trustex lubricated Condoms | Global Protection Corp. | 18 |
| Primeros | Richter Rubber Technology SDN. BHD. | 18 |
Showing 12 of 688. All products under Condom
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252622 | 2026-05-04 |
| K243584 | 2025-02-18 |
| K192669 | 2020-07-24 |
| K141256 | 2014-07-23 |
| K140379 | 2014-07-01 |
| K090259 | 2009-03-31 |
| K952393 | 1995-08-09 |
| K902804 | 1990-08-13 |
| K896339 | 1990-01-10 |
| K884402 | 1989-03-10 |
| K884401 | 1989-01-12 |
| K875111 | 1988-02-26 |
| K872664 | 1987-11-05 |
| K872812 | 1987-11-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.