The following data is part of a premarket notification filed by Ansell Heathcare Products Llc with the FDA for Lifestyles Zero Lubricated Latex Condom.
| Device ID | K120394 |
| 510k Number | K120394 |
| Device Name: | LIFESTYLES ZERO LUBRICATED LATEX CONDOM |
| Classification | Condom |
| Applicant | ANSELL HEATHCARE PRODUCTS LLC 1635 INDUSTRIAL ROAD Dothan, AL 36303 |
| Contact | Cynthia Ingram |
| Correspondent | Cynthia Ingram ANSELL HEATHCARE PRODUCTS LLC 1635 INDUSTRIAL ROAD Dothan, AL 36303 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-08 |
| Decision Date | 2012-05-08 |
| Summary: | summary |