Cleared Traditional

PRIMAGARD Isolation Gown (AAMI PB70 Level 3)

K160361 · Primed Medical Products, Inc. · General Hospital
Nov 2016
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K160361 is an FDA 510(k) clearance for the PRIMAGARD Isolation Gown (AAMI PB70 Level 3), a Gown, Isolation, Surgical (Class II — Special Controls, product code FYC), submitted by Primed Medical Products, Inc. (Edmonton, CA). The FDA issued a Cleared decision on November 4, 2016, 269 days after receiving the submission on February 9, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K160361 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2016
Decision Date November 04, 2016
Days to Decision 269 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FYC — Gown, Isolation, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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