FDA device listing

Polymer Patient Examination Glove

FDA device listing 1784094938 · VEENAK INTERNATIONAL LIMITED

Key facts

Owner/operator VEENAK INTERNATIONAL LIMITED
Owner/operator number 10058153
Premarket submissions K101596
Product codes LZA, LZC
Device names LZA - Polymer Patient Examination Glove, LZC - Medical Glove, Specialty
Device class Class I
Classification regulations (21 CFR) 880.6250
Review panels General Hospital
Registered establishments VEENAK INTERNATIONAL LIMITED
Establishment registrations 3013298431
FEI numbers 3013298431
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

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