Cleared Traditional

Isolation Gown AAMI Level 3

K212504 · Kenpax International Limited · General Hospital
Nov 2021
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K212504 is an FDA 510(k) clearance for the Isolation Gown AAMI Level 3, a Gown, Isolation, Surgical (Class II — Special Controls, product code FYC), submitted by Kenpax International Limited (Hong Kong, CN). The FDA issued a Cleared decision on November 7, 2021, 90 days after receiving the submission on August 9, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K212504 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2021
Decision Date November 07, 2021
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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