The following data is part of a premarket notification filed by Nulatex Sdn. Bhd. with the FDA for Male Latex Condom.
| Device ID | K132107 |
| 510k Number | K132107 |
| Device Name: | MALE LATEX CONDOM |
| Classification | Condom |
| Applicant | NULATEX SDN. BHD. LOT 1870, 4TH MILES JALAN MENGKIBOL Kluang, Johor, MY 86000 |
| Contact | Ai Siang Teo |
| Correspondent | Ai Siang Teo NULATEX SDN. BHD. LOT 1870, 4TH MILES JALAN MENGKIBOL Kluang, Johor, MY 86000 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-08 |
| Decision Date | 2014-03-07 |