The following data is part of a premarket notification filed by O & M Halyard, Inc. with the FDA for Skybreeze Zero Nitrile Powder-free Exam Glove Tested For Use With Chemotherapy Drugs.
| Device ID | K182851 |
| 510k Number | K182851 |
| Device Name: | SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | O & M Halyard, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Contact | Angela L. Bunn |
| Correspondent | Angela L. Bunn O & M Halyard, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-10 |
| Decision Date | 2019-06-26 |