The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Eudermic Mp Latex Examination Glove-blue (tested For Use With Chemotherapy Drugs) W/ A Protein Content Label Claim.
| Device ID | K103602 |
| 510k Number | K103602 |
| Device Name: | EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM |
| Classification | Latex Patient Examination Glove |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 -4486 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 -4486 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-08 |
| Decision Date | 2011-04-21 |
| Summary: | summary |