The following data is part of a premarket notification filed by Innovative Gloves Co; Ltd with the FDA for Nitrile Examination Gloves Powderfree (blue Color).
| Device ID | K021668 |
| 510k Number | K021668 |
| Device Name: | NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR) |
| Classification | Polymer Patient Examination Glove |
| Applicant | INNOVATIVE GLOVES CO; LTD 500 M004, T. KUANLUNG, HATYAI, Songkhla, TH 90110 |
| Contact | Rajeev Kumar Sood |
| Correspondent | Rajeev Kumar Sood INNOVATIVE GLOVES CO; LTD 500 M004, T. KUANLUNG, HATYAI, Songkhla, TH 90110 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-21 |
| Decision Date | 2002-08-12 |