FDA device listing
Powder Free Nitrile Examination Glove
FDA device listing 1336348689 · New Pentastar Medical Products Co. Limited
Key facts
| Proprietary names | Powder Free Nitrile Examination Glove |
|---|---|
| Owner/operator | New Pentastar Medical Products Co. Limited |
| Owner/operator number | 10063374 |
| Premarket submissions | K233598 |
| Product codes | LZA, LZC, OPJ, QDO |
| Device names | LZA - Polymer Patient Examination Glove, LZC - Medical Glove, Specialty, OPJ - Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs, QDO - Fentanyl And Other Opioid Protection Glove |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6250 |
| Review panels | General Hospital |
| Registered establishments | JIANGSU NEW PENTASTAR MEDICAL PRODUCTS CO. LTD. |
| Establishment registrations | 3015058854 |
| FEI numbers | 3015058854 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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