The following data is part of a premarket notification filed by Innovative Gloves Co; Ltd with the FDA for Innovative Gloves, Latex Examination Gloves Powderfree.
| Device ID | K993222 |
| 510k Number | K993222 |
| Device Name: | INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES POWDERFREE |
| Classification | Latex Patient Examination Glove |
| Applicant | INNOVATIVE GLOVES CO; LTD 11 CHOTEVITTAYAKUL 3 RD. Hatyai, Songkhla, TH |
| Contact | Rajeev Kumar Sood |
| Correspondent | Rajeev Kumar Sood INNOVATIVE GLOVES CO; LTD 11 CHOTEVITTAYAKUL 3 RD. Hatyai, Songkhla, TH |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-27 |
| Decision Date | 1999-11-05 |