The following data is part of a premarket notification filed by Halyard Health with the FDA for Halyard Lavender Nitrile Powder-free Exam Glove Tested For Use With Chemotherapy Drugs.
| Device ID | K180646 |
| 510k Number | K180646 |
| Device Name: | Halyard Lavender Nitrile Powder-Free Exam Glove Tested For Use With Chemotherapy Drugs |
| Classification | Patient Examination Glove, Specialty |
| Applicant | Halyard Health 5405 Windward Parkway Alpharetta, GA 30004 |
| Contact | Christine L. Macauley |
| Correspondent | Christine L. Macauley Halyard Health 5405 Windward Parkway Alpharetta, GA 30004 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-12 |
| Decision Date | 2018-06-27 |
| Summary: | summary |