P.S.
This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length…
This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180 mm, nominal width 52 mm, and nominal thickness 0.045mm. It is lubricated with silicone and cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and IS0 407. The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the 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 | Issawrap, Inc, United States |
|---|---|
| FDA product code | HIS |
| Device type | Condom |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5300 |
| Establishment | Repacker / relabeller |
| Record published | 2019-06-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Exceptionally Thin Latex Condoms | 12 | 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
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.