Cleared Abbreviated

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield

K171162 · Prestige Ameritech · General Hospital
Aug 2017
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K171162 is an FDA 510(k) clearance for the Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Prestige Ameritech (North Richland Hills, US). The FDA issued a Cleared decision on August 15, 2017, 117 days after receiving the submission on April 20, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K171162 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2017
Decision Date August 15, 2017
Days to Decision 117 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FXX — Mask, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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