MSH

35 FDA 510(k) clearances · Product code

FDA profile

Official device name

Respirator, Surgical

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4040

Medical specialty

General, Plastic Surgery

FDA definition

A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures subject to 21 CFR 878.9 and the conditions for exemption identified in 21 CFR 878.4040(b)(1).

Adverse events (MAUDE)

2020: 59 · 2021: 19 · 2022: 18 · 2023: 71
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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