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510(k) K242937

Dream Medi Sterile Surgical Gown (SurgicalGownUL) by Dae Myung Chemical Co., Ltd. (Vietnam) — Product Code FYA

K242937 is an FDA 510(k) premarket notification submitted by Dae Myung Chemical Co., Ltd. (Vietnam) for the device "Dream Medi Sterile Surgical Gown (SurgicalGownUL)". The FDA issued a decision of Substantially Equivalent on May 5, 2025. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2025
Date Received
September 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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FDA data resources