The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Mediguard Nitrile Examination Glove- Blue (tested For Use With Chemotherapy Drugs).
| Device ID | K093726 |
| 510k Number | K093726 |
| Device Name: | MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) |
| Classification | Polymer Patient Examination Glove |
| 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-03 |
| Decision Date | 2010-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889942529414 | K093726 | 000 |
| 10888277060500 | K093726 | 000 |
| 10888277060517 | K093726 | 000 |
| 10888277060531 | K093726 | 000 |
| 10889942246748 | K093726 | 000 |
| 10889942499434 | K093726 | 000 |
| 10889942499441 | K093726 | 000 |
| 10889942499458 | K093726 | 000 |
| 10889942499557 | K093726 | 000 |
| 10889942529360 | K093726 | 000 |
| 10889942529377 | K093726 | 000 |
| 10889942529384 | K093726 | 000 |
| 10889942529391 | K093726 | 000 |
| 10889942529407 | K093726 | 000 |
| 10193489486346 | K093726 | 000 |