The following data is part of a premarket notification filed by Global Protection Corp. with the FDA for Non-spermicidal Lubricated Male Latex Condom.
| Device ID | K193578 |
| 510k Number | K193578 |
| Device Name: | Non-spermicidal Lubricated Male Latex Condom |
| Classification | Condom |
| Applicant | Global Protection Corp. 12 Channel Street Boston, MA 02210 |
| Contact | Christina Cataldo |
| Correspondent | Christina Cataldo Global Protection Corp. 12 Channel Street Boston, MA 02210 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-23 |
| Decision Date | 2020-08-20 |