Fama Male Latex Condoms
FAMA Male Latex Condoms are single-use barrier sheaths made from natural rubber latex. They have straight walls and a nipple-ended design, with smooth, dotted or ribbed surface options. The…
FAMA Male Latex Condoms are single-use barrier sheaths made from natural rubber latex. They have straight walls and a nipple-ended design, with smooth, dotted or ribbed surface options.
The condoms are lubricated with silicone oil and contain no added colourants or fragrances. The sheath fits over the penis to provide the physical barrier.
Forms and Intended Use
The range has a nominal width of 53 mm and length of 180 mm, with thickness varying by surface type. Condoms are supplied nonsterile in individual aluminium-film packaging for contraception and to help reduce transmission of sexually transmitted infections.
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 | Shanghai Personage Hygiene Products Co., Ltd., China |
|---|---|
| FDA product code | HIS |
| Device type | Condom |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5300 |
| Establishment | Manufacturer |
| 510(k) | K220576 |
| Record published | 2024-07-26 |
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 |
| Storage | Special storage condition: Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Packaging | Carton of 10, carton of 3, case of 90, carton of 36, case of 84, case of 112 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 53mm,Condom(Ribbed) | In distribution | |
| 53mm,Condom(Ribbed) | In distribution | |
| 53mm,Condom(Plain) | In distribution | |
| 53mm,Condom(Dotted) | In distribution | |
| 53mm,Condom(Dotted) | In distribution | |
| 53mm,Condom(Dotted) | In distribution | |
| 53mm,Condom(Ribbed) | In distribution | |
| 53mm,Condom(Dotted) | In distribution | |
| 53mm,Condom(Ribbed) | In distribution | |
| 53mm,Condom(Plain) | In distribution | |
| 53mm,Condom (Plain) | In distribution |
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 |
|---|---|
| K220576 | 2022-08-05 |
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.