FDA device listing
CARACAL velvet NBR PF VB 300pc,Care One Nitrile Exam,CareOne Nitrile NBR PF VB,DealMed Nitrile Exam (100 count),DealMed…
FDA device listing 1320669221 · HARPS Investment Asia Pte. Ltd.
Key facts
| Proprietary names | CARACAL velvet NBR PF VB 300pc,Care One Nitrile Exam,CareOne Nitrile NBR PF VB,DealMed Nitrile Exam (100 count),DealMed Nitrile Exam (200 count),DealMed Nitrile Exam (300 count),DealMed Nitrile Exam NBR PF VB 100pc,DealMed Nitrile Exam NBR PF VB 300pc,DirectSafety Nitrile Light Exam PF,Essentials Nitrile Exam,Essentials Ultra Nitrile Exam,Gemini Nitrile Exam,GlovePak Azurite Nitrile Exam,GlovePak… |
|---|---|
| Owner/operator | HARPS Investment Asia Pte. Ltd. |
| Owner/operator number | 10045460 |
| Premarket submissions | K211022 |
| 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 | HARPS Investment Asia Pte. Ltd. |
| Establishment registrations | 3010605427 |
| FEI numbers | 3010605427 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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