The following data is part of a premarket notification filed by Shanghai Latex Factory with the FDA for Profect Examination Gloves.
| Device ID | K893280 |
| 510k Number | K893280 |
| Device Name: | PROFECT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | SHANGHAI LATEX FACTORY 5959 WESTHEIMER SUITE 366 Houston, TX 77057 |
| Contact | Derick Li |
| Correspondent | Derick Li SHANGHAI LATEX FACTORY 5959 WESTHEIMER SUITE 366 Houston, TX 77057 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-17 |
| Decision Date | 1989-09-11 |