DeviceClearance

Product code MSH— General, Plastic Surgery

3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870

Classification name
Respirator, Surgical
Device class
Class 2
Regulation
21 CFR 878.4040
Advisory panel
General, Plastic Surgery
Total cleared
35
First cleared
Most recent

FDA classification 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).”

— U.S. Food and Drug Administration, device classification record for product code MSH under 21 CFR 878.4040, via openFDA

Market context for product code MSH

FDA has cleared 35 devices under product code MSH between 1996 and 2024, filed by 24 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code MSH

Recent clearances under product code MSH

Data sourced from openFDA. This site is unofficial and independent of the FDA.