The following data is part of a premarket notification filed by Emerson & Co. Srl with the FDA for Polyisoprene Powder Free, Black Colour Surgical Gloves.
| Device ID | K192933 |
| 510k Number | K192933 |
| Device Name: | Polyisoprene Powder Free, Black Colour Surgical Gloves |
| Classification | Surgeon's Gloves |
| Applicant | Emerson & Co. Srl Piazza Della Vittoria 10 Genoa, IT 16121 |
| Contact | Laura Figliomeni |
| Correspondent | Laura Figliomeni Emerson & Co. Srl Piazza Della Vittoria 10 Genoa, IT 16121 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-17 |
| Decision Date | 2021-01-13 |