The following data is part of a premarket notification filed by Innovative Gloves Co; Ltd with the FDA for Black Nitrile Examination Gloves.
| Device ID | K083908 |
| 510k Number | K083908 |
| Device Name: | BLACK NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | INNOVATIVE GLOVES CO; LTD 830 MOO 4 SANAMBIN-BANKLANG RD TAMBON KUANLANG, AMPHUR HATYAI Songkhla, TH 90110 |
| Contact | Rajeev K Sood |
| Correspondent | Rajeev K Sood INNOVATIVE GLOVES CO; LTD 830 MOO 4 SANAMBIN-BANKLANG RD TAMBON KUANLANG, AMPHUR 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 | 2008-12-30 |
| Decision Date | 2009-03-06 |
| Summary: | summary |