The following data is part of a premarket notification filed by 0 & M Halyard, Inc with the FDA for Halyard Black-fire Powder-free Nitrile Exam Glove, Halyard Purple Powder-free Nitrile Exam Glove.
| Device ID | K200633 |
| 510k Number | K200633 |
| Device Name: | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove |
| Classification | Patient Examination Glove, Specialty |
| Applicant | 0 & M Halyard, Inc 5405 Windward Parkway Alpharetta, GA 30004 |
| Contact | Steven Dowdley |
| Correspondent | Steven Dowdley 0 & M Halyard, Inc 5405 Windward Parkway Alpharetta, GA 30004 |
| Product Code | LZC |
| Subsequent Product Code | LZA |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-10 |
| Decision Date | 2020-10-11 |