The following data is part of a premarket notification filed by O & M Haylard, Inc. with the FDA for Halyard Purple Xtra And Purple Sterile, Low Dermatitis Potential, Powder-free Exam Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate.
| Device ID | K192241 |
| 510k Number | K192241 |
| Device Name: | Halyard Purple Xtra And Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate |
| Classification | Polymer Patient Examination Glove |
| Applicant | O & M Haylard, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Contact | Steven Dowdley |
| Correspondent | Steven Dowdley O & M Haylard, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-19 |
| Decision Date | 2020-03-13 |