The following data is part of a premarket notification filed by Guangzhou Daming United Rubber Products Ltd. with the FDA for Aoni Natural Rubber Latex Condom.
| Device ID | K153016 |
| 510k Number | K153016 |
| Device Name: | Aoni Natural Rubber Latex Condom |
| Classification | Condom |
| Applicant | Guangzhou Daming United Rubber Products Ltd. NO. 1 Daming Street, Port Industrial Zone Huada District Guangzhou, CN 510802 |
| Contact | Yongbing Xie |
| Correspondent | Yongbing Xie Guangzhou Daming United Rubber Products Ltd. NO. 1 Daming Street, Port Industrial Zone Huada District Guangzhou, CN 510802 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-15 |
| Decision Date | 2016-10-20 |
| Summary: | summary |