FDA device listing
PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves
FDA device listing 1486179310 · O&M Halyard, Inc.
Key facts
| Proprietary names | PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves |
|---|---|
| Owner/operator | O&M Halyard, Inc. |
| Owner/operator number | 10057479 |
| Premarket submissions | K192241 |
| Product codes | LZA, LZC, QDO |
| Device names | LZA - Polymer Patient Examination Glove, LZC - Medical Glove, Specialty, QDO - Fentanyl And Other Opioid Protection Glove |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6250 |
| Review panels | General Hospital |
| Registered establishments | O&M Halyard, Inc., SAFESKIN MEDICAL & SCIENTIFIC (THAILAND), LTD. |
| Establishment registrations | 9614175, 3014421917 |
| FEI numbers | 1000297006, 3014421917 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database