The following data is part of a premarket notification filed by Innovative Gloves Co; Ltd with the FDA for Latex Examination Gloves Powder-free (black Color) With Protein Labeling Claim (50 Micrograms Or Less).
| Device ID | K111158 |
| 510k Number | K111158 |
| Device Name: | LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | INNOVATIVE GLOVES CO; LTD 830 MOO 4 SANAMBIN-BANKLANG RD KUANLANG Hatyai, Songkhla, TH 90110 |
| Contact | Rajeev Sood |
| Correspondent | Rajeev Sood INNOVATIVE GLOVES CO; LTD 830 MOO 4 SANAMBIN-BANKLANG RD KUANLANG Hatyai, Songkhla, TH 90110 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-25 |
| Decision Date | 2011-08-10 |