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FDA 510(k)

Skypro, Surgical Gown 6021

K-Number: K230707 · 2023-10-12

ApplicantSkypro Medical Supplies Company
Decision Date2023-10-12
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Skypro, Surgical Gown 6021 is the device name listed in this FDA 510(k) record. The listed applicant is Skypro Medical Supplies Company. It received FDA 510(k) clearance on 2023-10-12 under 510(k) number K230707. 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 Skypro, Surgical Gown 6021?

Skypro, Surgical Gown 6021 is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is Skypro Medical Supplies Company. The 510(k) number is K230707.

When did Skypro, Surgical Gown 6021 receive FDA 510(k) clearance?

Skypro, Surgical Gown 6021 received FDA 510(k) clearance on 2023-10-12, under 510(k) number K230707.

Who is the listed applicant for Skypro, Surgical Gown 6021?

The FDA 510(k) record lists Skypro Medical Supplies Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Skypro, Surgical Gown 6021?

The FDA product code for Skypro, Surgical Gown 6021 is FYA.

Other records listing Skypro Medical Supplies Company as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202255Skypro, SP02 Mask (3)K152197Skypro, SP01 Mask

Related Devices (Code: FYA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery StudioK252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLCK253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)Hubei Xinxin Non-Woven Co., Ltd.

Official Source

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

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