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FDA 510(k)

Dream Medi Sterile Surgical Gown (SurgicalGownUL)

K-Number: K242937 · 2025-05-05

ApplicantDae Myung Chemical Co., Ltd. (Vietnam)
Decision Date2025-05-05
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dream Medi Sterile Surgical Gown (SurgicalGownUL) is a medical device manufactured by Dae Myung Chemical Co., Ltd. (Vietnam). It received FDA 510(k) clearance on 2025-05-05 under approval number K242937. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dream Medi Sterile Surgical Gown (SurgicalGownUL)?

Dream Medi Sterile Surgical Gown (SurgicalGownUL) is a medical device that received FDA 510(k) clearance on 2025-05-05. It is manufactured by Dae Myung Chemical Co., Ltd. (Vietnam). The 510(k) number is K242937.

When was Dream Medi Sterile Surgical Gown (SurgicalGownUL) approved by the FDA?

Dream Medi Sterile Surgical Gown (SurgicalGownUL) received FDA 510(k) clearance on 2025-05-05, under approval number K242937.

What company makes Dream Medi Sterile Surgical Gown (SurgicalGownUL)?

Dream Medi Sterile Surgical Gown (SurgicalGownUL) is manufactured by Dae Myung Chemical Co., Ltd. (Vietnam).

What is the FDA product code for Dream Medi Sterile Surgical Gown (SurgicalGownUL)?

The FDA product code for Dream Medi Sterile Surgical Gown (SurgicalGownUL) is FYA.

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Related Devices (Code: FYA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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