The following data is part of a premarket notification filed by Allied Rubber Industries Sdn. Bhd. with the FDA for Guardian & Janitex Condom/prophylactic.
| Device ID | K896098 |
| 510k Number | K896098 |
| Device Name: | GUARDIAN & JANITEX CONDOM/PROPHYLACTIC |
| Classification | Condom |
| Applicant | ALLIED RUBBER INDUSTRIES SDN. BHD. 2009, KAWASAN MIEL LOT 2, JALAN BEREMBAN 15/12, 400000 Shah Alam.malaysia, MY |
| Contact | Tong |
| Correspondent | Tong ALLIED RUBBER INDUSTRIES SDN. BHD. 2009, KAWASAN MIEL LOT 2, JALAN BEREMBAN 15/12, 400000 Shah Alam.malaysia, MY |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-20 |
| Decision Date | 1990-12-19 |