Cleared Traditional

Dream Medi Sterile Surgical Gown (SurgicalGownUL)

K242937 · Dae Myung Chemical Co., Ltd. (Vietnam) · General Hospital

May 2025

Decision

222d

Days

Class 2

Risk

About This 510(k) Submission

K242937 is an FDA 510(k) clearance for the Dream Medi Sterile Surgical Gown (SurgicalGownUL), a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Dae Myung Chemical Co., Ltd. (Vietnam) (Long Thanh, VN). The FDA issued a Cleared decision on May 5, 2025, 222 days after receiving the submission on September 25, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K242937 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2024
Decision Date	May 05, 2025
Days to Decision	222 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF