The following data is part of a premarket notification filed by Halyard Health with the FDA for Fusion Black Powder-free Nitrile Exam Glove.
| Device ID | K150113 |
| 510k Number | K150113 |
| Device Name: | Fusion Black Powder-Free Nitrile Exam Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Halyard Health 1400 Holcomb Bridge Rd. Roswell, GA 30076 |
| Contact | Christine L Macauley |
| Correspondent | Christine L Macauley Halyard Health 1400 Holcomb Bridge Rd. Roswell, GA 30076 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-20 |
| Decision Date | 2015-06-18 |
| Summary: | summary |