The following data is part of a premarket notification filed by Innolatex Sdn. Bhd with the FDA for Ultra Thick Male Latex Condom With Silicone Lubricant.
| Device ID | K012664 |
| 510k Number | K012664 |
| Device Name: | ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT |
| Classification | Condom |
| Applicant | INNOLATEX SDN. BHD NO 16, JALAN BULAN U5/5 BANDAR PINGGIRAN SUBANG, Shah Alam,selangor Darul Ehsan, MY |
| Contact | Chang Ah-kau |
| Correspondent | Chang Ah-kau INNOLATEX SDN. BHD NO 16, JALAN BULAN U5/5 BANDAR PINGGIRAN SUBANG, Shah Alam,selangor Darul Ehsan, MY |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-13 |
| Decision Date | 2001-11-09 |