Cleared Traditional

K972410 - IMPERVIOUS ISOLATION GOWN
(FDA 510(k) Clearance)

K972410 · Kentron Health Care, Inc. · General Hospital

Sep 1997

Decision

85d

Days

Class 2

Risk

K972410 is an FDA 510(k) clearance for the IMPERVIOUS ISOLATION GOWN. This device is classified as a Gown, Isolation, Surgical (Class II — Special Controls, product code FYC).

Submitted by Kentron Health Care, Inc. (Springfield, US). The FDA issued a Cleared decision on September 19, 1997, 85 days after receiving the submission on June 26, 1997.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K972410 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 1997
Decision Date	September 19, 1997
Days to Decision	85 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement