The following data is part of a premarket notification filed by Emerson & Co. S.r.l. with the FDA for Proguard Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm.
| Device ID | K151228 |
| 510k Number | K151228 |
| Device Name: | PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm |
| Classification | Surgeon's Gloves |
| Applicant | EMERSON & CO. S.R.L. PIAZZA DELLA VITTORIA, 10 Genoa, IT 16121 |
| Contact | Stefano Costigliolo |
| Correspondent | Stefano Costigliolo EMERSON & CO. S.R.L. PIAZZA DELLA VITTORIA, 10 Genoa, IT 16121 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-07 |
| Decision Date | 2016-01-15 |