Custom Condoms
Top Shelf Condom Assortment case- The description of condoms included in the case are as follows- Lifestyle extra strength (A5900C), Lifestyle snugger fit (A5200C), - Lifestyle Assorted…
Top Shelf Condom Assortment case- The description of condoms included in the case are as follows- Lifestyle extra strength (A5900C), Lifestyle snugger fit (A5200C), – Lifestyle Assorted colors (A5300C), Lifestyles Large (A9800C), Lifestyle Ultra lubricated (A5800C), Lifestyle Ultra sensitive (A5400C), Rough Rider Lubricated (A4541C), Lifestyles Ultra Thin Condoms (A6400C) D293219- One Super studs Crown condoms (LC21C) D293966- Trustex Extra large
9manufacturers in China registered for this device type
94catalogue numbers in this listing
4510(k) clearances naming this product code
1recall
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 | Global Protection Corp., United States |
|---|---|
| FDA product code | HIS |
| Device type | Condom |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5300 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2024-11-25 |
| Record revised | 2024-02-08 (version 2) |
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 at room temperature in a dark, dry place. Avoid excessive heat |
| Packaging | Inner box of 100 of 100, inner box of 100, pe bag of 100 of 100, pe bag of 144 of 144, case of 1000 of 1000 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| BSC | 500 | In distribution | |
| BKU55 | 50 | In distribution | |
| BKU33 | 50 | In distribution | |
| BKU69 | 50 | In distribution | |
| BKU8 | 50 | In distribution | |
| CTB02U | 36 | In distribution | |
| CC-SQ01-SVR | 1,000 | In distribution | |
| MG08U | 36 | In distribution | |
| SPU7 | 50 | In distribution | |
| BKU5 | 50 | In distribution | |
| SK22 | 50 | In distribution | |
| SK12 | 50 | In distribution | |
| BKU65 | 50 | In distribution | |
| SPU8 | 50 | In distribution | |
| BKU34 | 50 | In distribution | |
| CC-BC01 | 72 | In distribution | |
| MG12U | 36 | In distribution | |
| BKU31 | 50 | In distribution | |
| BKU73 | 50 | In distribution | |
| BKU64 | 50 | In distribution | |
| BKU58 | 50 | In distribution | |
| STUK | 50 | In distribution | |
| MG03U | 36 | In distribution | |
| SEGU | 25 | In distribution | |
| BKU56 | 50 | In distribution | |
| BKU72 | 50 | In distribution | |
| MG09U | 36 | In distribution | |
| SK32 | 50 | In distribution | |
| BKU6 | 50 | In distribution | |
| BKU30 | 50 | In distribution | |
| BKU78 | 50 | In distribution | |
| HPUO | 50 | In distribution | |
| STUH | 50 | In distribution | |
| CTB04U | 36 | In distribution | |
| CC-SQ01-GLD | 1,000 | In distribution | |
| BKU49 | 50 | In distribution | |
| BKU82 | 50 | In distribution | |
| BKU54 | 50 | In distribution | |
| BKU9 | 50 | In distribution | |
| SPU4 | 50 | In distribution | |
| BKU66 | 50 | In distribution | |
| BKU60 | 50 | In distribution | |
| BKU67 | 50 | In distribution | |
| VPU4R | 50 | In distribution | |
| BKU44 | 50 | In distribution | |
| BKU61 | 50 | In distribution | |
| SPU1 | 50 | In distribution | |
| CTB03U | 36 | In distribution | |
| BKU63 | 50 | In distribution | |
| SPU6 | 50 | In distribution | |
| BKU45 | 50 | In distribution | |
| BKU46 | 50 | In distribution | |
| CC-SQ02-CLR | 1,008 | In distribution | |
| CC-SQ01-WHT | 1,000 | In distribution | |
| BKU74 | 50 | In distribution | |
| BKU59 | 50 | In distribution | |
| BKU81 | 50 | In distribution | |
| BKU70 | 50 | In distribution | |
| CTB01U | 36 | In distribution | |
| SPU5 | 50 | In distribution | |
| BKU80 | 50 | In distribution | |
| MG06U | 36 | In distribution | |
| BKU32 | 50 | In distribution | |
| MG07U | 36 | In distribution | |
| CTB05U | 36 | In distribution | |
| BKU62 | 50 | In distribution | |
| SPR | 50 | In distribution | |
| SK-TS | 1,024 | In distribution | |
| BKU79 | 50 | In distribution | |
| MG11U | 36 | In distribution | |
| CC-SQ03-GLD | 1,000 | In distribution | |
| BKU48 | 50 | In distribution | |
| MG04U | 36 | In distribution | |
| BKU68 | 50 | In distribution | |
| CC-SQ01-BLK | 1,000 | In distribution | |
| SPU3 | 50 | In distribution | |
| SK42 | 50 | In distribution | |
| BKU75 | 50 | In distribution | |
| BKU38 | 50 | In distribution | |
| BKU37 | 50 | In distribution | |
| BKU76 | 50 | In distribution | |
| CC-SQ03-BLK | 1,000 | In distribution | |
| BKU57 | 50 | In distribution | |
| BKU71 | 50 | In distribution | |
| TPR | 48 | In distribution | |
| SPU2 | 50 | In distribution | |
| CSDF-0 | 100 | In distribution | |
| BKU77 | 50 | In distribution | |
| BKU47 | 50 | In distribution | |
| VPU1R | 50 | In distribution | |
| BBU-1 | 128 | In distribution | |
| CC-SQ01-RED | 1,000 | In distribution | |
| SK52 | 50 | In distribution | |
| PP24-CKIT | 500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lifestyles | Suretex Limited – Branch | 158 |
| 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 |
| ID Condoms | Westridge Laboratories, Inc | 17 |
Showing 12 of 688. All products under Condom
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203536 | 2021-09-03 |
| K193578 | 2020-08-20 |
| K024324 | 2003-03-25 |
| K960552 | 1997-11-20 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-09-11 | Not classified | Process control | Condoms fail the water leak test and package integrity | 127,00 condoms | 2008-03-18 |
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.