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510(k) K081923

ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD by Glaxosmithkline Consumer Healthcare — Product Code ONT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2009
Date Received
July 7, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
N95 Respirator With Antimicrobial/Antiviral Agent
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

A single use, disposable, NIOSH-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions.

Other clearances by Glaxosmithkline Consumer Healthcare

  • K093189 — ACTIPROTECT UC N95 RESPIRATOR (July 2, 2010)
  • K093161 — ACTIPROTECT UF N95 RESPIRATOR (May 10, 2010)

Other clearances for product code ONT

  • K150729 — SpectraShield 9500 Surgical N95 Respirator (December 29, 2015)
  • K122702 — BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR (March 18, 2013)
  • K120244 — SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR (July 5, 2012)
  • K090414 — SPECTRASHIELD 9500 SURGICAL MASK (February 24, 2011)
  • K093161 — ACTIPROTECT UF N95 RESPIRATOR (May 10, 2010)