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510(k) K160271

N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 by San-M Package Co., Ltd. — Product Code MSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2016
Date Received
February 2, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Respirator, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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).

Other clearances by San-M Package Co., Ltd.

  • K221534 — Surgical Face Masks (Ear Loops And Tie-On) (September 16, 2022)
  • K160269 — Surgical Face Masks (Ear loops and Tie-on) (September 6, 2016)

Other clearances for product code MSH

  • K233022 — Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with S (January 12, 2024)
  • K172963 — Master-Frank N95 Particulate Respirator (April 4, 2018)
  • K171116 — 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/18 (August 10, 2017)
  • K141876 — Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, P (October 28, 2015)
  • K121069 — 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK (February 11, 2013)
  • K102923 — BARRIER N95 PARTICULATE RESPIRATOR (November 19, 2010)
  • K102092 — PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL (October 6, 2010)
  • K102173 — MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 17 (September 13, 2010)
  • K100139 — SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 (May 4, 2010)
  • K092824 — N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 (October 21, 2009)