Cleared Traditional

DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)

K031408 · Deroyal · General Hospital
Oct 2003
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K031408 is an FDA 510(k) clearance for the DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE), a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Deroyal (Knoxville, US). The FDA issued a Cleared decision on October 15, 2003, 163 days after receiving the submission on May 5, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K031408 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2003
Decision Date October 15, 2003
Days to Decision 163 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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