The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Powder-free Latex Surgical Gloves, Sterile, W/ Or W/o Aloe Vera, With Protein Content Labeling Claim....
| Device ID | K111807 |
| 510k Number | K111807 |
| Device Name: | MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM... |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-27 |
| Decision Date | 2011-08-18 |