FDA device listing

REPEL LITE CUT RESISTENT GLOVE LINERS

FDA device listing 1915499049 · Exel Inc. dba DHL Supply Chain (USA)

Key facts

Proprietary names REPEL LITE CUT RESISTENT GLOVE LINERS
Owner/operator Exel Inc. dba DHL Supply Chain (USA)
Owner/operator number 10026656
Premarket submissions K914077
Product codes LYU
Device names LYU - Accessory, Surgical Apparel
Device class Class I
Classification regulations (21 CFR) 878.4040
Review panels General & Plastic Surgery
Registered establishments EXEL INC. DBA DHL SUPPLY CHAIN (USA)
Establishment registrations 3008868758
FEI numbers 3008868758
Establishment operations Repackager/Relabeler
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

Browse all FDA device listings