The following data is part of a premarket notification filed by Glormed Colombia S.a. with the FDA for Powder-free Vinyl Examination Gloves.
| Device ID | K071022 |
| 510k Number | K071022 |
| Device Name: | POWDER-FREE VINYL EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | GLORMED COLOMBIA S.A. 2700 NORTH MAIN STREET SUITE 506 Santa Ana, CA 92705 |
| Contact | Sam Kao |
| Correspondent | Sam Kao GLORMED COLOMBIA S.A. 2700 NORTH MAIN STREET SUITE 506 Santa Ana, CA 92705 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-11 |
| Decision Date | 2007-07-05 |
| Summary: | summary |