The following data is part of a premarket notification filed by Innolatex Sdn. Bhd with the FDA for Male Natural Rubber Latex Condom.
| Device ID | K053367 |
| 510k Number | K053367 |
| Device Name: | MALE NATURAL RUBBER LATEX CONDOM |
| Classification | Condom |
| Applicant | INNOLATEX SDN. BHD PANDAMARAN INDUSTRIAL ESTATE PORT KLANG Selangor Darul Ehsan, MY 42000 |
| Contact | Goh Miah Kiat |
| Correspondent | Goh Miah Kiat INNOLATEX SDN. BHD PANDAMARAN INDUSTRIAL ESTATE PORT KLANG Selangor Darul Ehsan, MY 42000 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-05 |
| Decision Date | 2006-02-21 |