The following data is part of a premarket notification filed by O & M Halyard, Inc. with the FDA for Halyard Sterling* Nitrile Powder-free Exam Gloves, Halyard Sterling Sg* Nitrile Sensi-guard Powder-free Exam Gloves.
| Device ID | K191230 |
| 510k Number | K191230 |
| Device Name: | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves |
| Classification | Patient Examination Glove, Specialty |
| Applicant | O & M Halyard, Inc. 9120 Lockwood Blvd Mechanicsville, VA 23116 |
| Contact | Steve Dowdlley |
| Correspondent | Steve Dowdlley O & M Halyard, Inc. 9120 Lockwood Blvd Mechanicsville, VA 23116 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-08 |
| Decision Date | 2019-11-08 |