The following data is part of a premarket notification filed by O & M Halyard, Inc. with the FDA for Halyard Flexaprene Green Powder-free Exam Glove.
| Device ID | K211063 |
| 510k Number | K211063 |
| Device Name: | HALYARD Flexaprene Green Powder-Free Exam Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | O & M Halyard, Inc. 1 Edison Drive Alpharetta, GA 30005 |
| Contact | Steven Dowdley |
| Correspondent | Steven Dowdley O & M Halyard, Inc. 1 Edison Drive Alpharetta, GA 30005 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-09 |
| Decision Date | 2021-11-19 |