The following data is part of a premarket notification filed by Innovative Gloves Co; Ltd with the FDA for Innovative Gloves, Nitrile Butadiene Rubber Powder-free.
| Device ID | K993325 |
| 510k Number | K993325 |
| Device Name: | INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE |
| Classification | Polymer 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-04 |
| Decision Date | 1999-11-05 |