FDA device listing

3 layer Disposable Mask,3 Layer Disposable Mask (Children's Mask),KN95 Mask

FDA device listing 1860413234 · Picard Industrial Corporation

Key facts

Proprietary names 3 layer Disposable Mask,3 Layer Disposable Mask (Children's Mask),KN95 Mask
Owner/operator Picard Industrial Corporation
Owner/operator number 10032672
Product codes MSH
Device names MSH - Respirator, Surgical
Device class Class II
Classification regulations (21 CFR) 878.4040
Review panels General & Plastic Surgery
Registered establishments Picard Healthcare Technology (Dongguan) Co. Ltd
Establishment registrations 3008466086
FEI numbers 3008466086
Establishment operations 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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