The following data is part of a premarket notification filed by Halyard Health with the FDA for Halyard* Purple Nitrile – Xtra* Powder-free Exam Gloves.
| Device ID | K160709 |
| 510k Number | K160709 |
| Device Name: | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves |
| Classification | Patient Examination Glove, Specialty |
| Applicant | Halyard Health 5405 Windward Parkway Alpharetta, GA 30004 |
| Contact | Gwendolyn George |
| Correspondent | Gwendolyn George Halyard Health 5405 Windward Parkway Alpharetta, GA 30004 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-14 |
| Decision Date | 2016-09-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651550904 | K160709 | 000 |
| 30680651506048 | K160709 | 000 |
| 30680651506031 | K160709 | 000 |
| 30680651506024 | K160709 | 000 |
| 30680651506017 | K160709 | 000 |
| 30680651504822 | K160709 | 000 |