The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Sensicare Powder-free Polymer Coated Polysoprene Surgical Gloves, Sterile.
| Device ID | K102177 |
| 510k Number | K102177 |
| Device Name: | SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE |
| Classification | Surgeon's Gloves |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-02 |
| Decision Date | 2011-06-30 |