Astroglide X Premium Silicone Gel Personal Lubricant
Astroglide X Premium Silicone Gel is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate activity…
Astroglide X Premium Silicone Gel is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Who Else Makes It
Concentrated in Guangdong (10), Zhejiang (3), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boya Biotechnology Company Limited | Dongguan | Guangdong | Contract manufacturer | 2 |
| Nantong Health & Beyond Hygienic Products Inc. | Rugao | Jiangsu | Contract manufacturer | 2 |
| Lvliang Lishi District Wenfeng Trade Co., Ltd. | Lvliang | Shanxi | Contract manufacturer | 1 |
| Yiwu Nianxun E-Commerce Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 1 |
| Foshan Niceday Sanitary Products Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 19 |
| Wenzhou Baiyu Glasses Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 10 |
| Foshan Pingchuang Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 9 |
| Shenzhen Beston E-Commerce Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 6 |
| Shenzhen Guangdian Technology Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 3 |
| Bath Concepts Cosmetics (DongGuan) Co., Ltd. | Dongguan | Guangdong | Repacker / relabeller | 2 |
| Yunbo Times (Taizhou) Technology Co., Ltd. | Taizhou | Zhejiang | Exporter | 2 |
| Dongguan Yanxuan Biotechnology Co., Ltd. | Dongguan | Guangdong | Manufacturer | 1 |
Showing 12 of 15. All 15 manufacturers in China registered for Lubricant, Personal
Record
| Listed by | Biofilm, Inc., United States |
|---|---|
| FDA product code | NUC |
| Device type | Lubricant, Personal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5300 |
| Establishment | Manufacturer |
| 510(k) | K163395 |
| Record published | 2023-06-07 |
| Record revised | 2020-08-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 70 to 77 °F |
| Sizes | Weight 2.5 to 85 g; total volume 3 Fluid Ounce |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 015594011769 | Weight 2.5 g | In distribution |
| 015594011752 | Total Volume 3 Fluid Ounce | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aloe Cadabra | Live Well Brands, Inc. | 32 |
| Skyn | Suretex Limited – Branch | 30 |
| pinknight | Guangzhou Haoyimai Trading Co., Ltd. | 27 |
| Swiss Navy | M.D. Science Lab, L.L.C. | 26 |
| überlube | Uberlube | 20 |
| ID Glide | Westridge Laboratories, Inc | 17 |
| WET Platinum Silicone Lubricant | Trigg Laboratories, Inc. | 15 |
| Lifestyles | Suretex Limited – Branch | 14 |
| Wet Flavored Lubricant | Trigg Laboratories, Inc. | 14 |
| Gun Oil | Empowered Products | 12 |
| ID Pleasure | Westridge Laboratories, Inc | 12 |
| Adam and Eve | Adam & Eve | 11 |
Showing 12 of 1,150. All products under Lubricant, Personal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221036 | 2022-07-01 |
| K220355 | 2022-05-26 |
| K220653 | 2022-05-06 |
| K213671 | 2022-03-03 |
| K210242 | 2021-04-28 |
| K200239 | 2020-11-13 |
| K200114 | 2020-10-13 |
| K171985 | 2017-08-30 |
| K163395 | 2017-02-10 |
| K140590 | 2014-10-30 |
| K141581 | 2014-08-06 |
| K072647 | 2008-01-25 |
| K003867 | 2001-03-09 |
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.