The following data is part of a premarket notification filed by Biofilm Inc. with the FDA for Astroglide Warming.
| Device ID | K221036 |
| 510k Number | K221036 |
| Device Name: | Astroglide Warming |
| Classification | Lubricant, Personal |
| Applicant | BioFilm Inc. 3225 Executive Ridge Vista, CA 92081 |
| Contact | Kevin Jamil |
| Correspondent | Kevin Jamil BioFilm Inc. 3225 Executive Ridge Vista, CA 92081 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-07 |
| Decision Date | 2022-07-01 |