The following data is part of a premarket notification filed by Halyard Health with the FDA for Halyard Black-orange Powder-free Nitrile Exam Glove.
| Device ID | K153708 |
| 510k Number | K153708 |
| Device Name: | Halyard Black-Orange Powder-Free Nitrile Exam Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Halyard Health 5405 Windward Parkway Alpharetta, GA 30004 |
| Contact | Christine L Macauley |
| Correspondent | Christine L Macauley Halyard Health 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 | 2015-12-23 |
| Decision Date | 2016-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651452604 | K153708 | 000 |
| 30680651447563 | K153708 | 000 |
| 30680651447570 | K153708 | 000 |
| 30680651447587 | K153708 | 000 |
| 30680651447594 | K153708 | 000 |
| 30680651452567 | K153708 | 000 |
| 30680651452574 | K153708 | 000 |
| 30680651452581 | K153708 | 000 |
| 30680651452598 | K153708 | 000 |
| 30680651447556 | K153708 | 000 |