The following data is part of a premarket notification filed by Medical-latex (dua) Sdn. Bhd with the FDA for Latex Male Condom (smooth Surface) Latex Male Condom (textured Surface).
| Device ID | K120555 |
| 510k Number | K120555 |
| Device Name: | LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE) |
| Classification | Condom |
| Applicant | MEDICAL-LATEX (DUA) SDN. BHD PLO 8 SENAI INDUSTRIAL ESTATE Senai, MY 81400 |
| Contact | Uma Devi |
| Correspondent | Uma Devi MEDICAL-LATEX (DUA) SDN. BHD PLO 8 SENAI INDUSTRIAL ESTATE Senai, MY 81400 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-23 |
| Decision Date | 2012-11-02 |