FDA device listing

LATEX POWDER FREE

FDA device listing 2033045594 · SW TECHNOLOGIES INC.

Key facts

Proprietary names LATEX POWDER FREE
Owner/operator SW TECHNOLOGIES INC.
Owner/operator number 2939388
Product codes LYY
Device names LYY - Latex Patient Examination Glove
Device class Class I
Classification regulations (21 CFR) 880.6250
Review panels General Hospital
Registered establishments ZHANGJIAGANG DAYU RUBBER PRODUCTS CO., LTD.
Establishment registrations 1000254914
FEI numbers 1000254914
Establishment operations Contract Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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