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FDA 510(k)

Surgical Gown (Sterile); Surgical Gown (Non-sterile)

K-Number: K221637 · 2022-09-29

ApplicantAllmed Medical (Hubei) Protective Products Co., Ltd.
Decision Date2022-09-29
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Gown (Sterile); Surgical Gown (Non-sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Allmed Medical (Hubei) Protective Products Co., Ltd.. It received FDA 510(k) clearance on 2022-09-29 under 510(k) number K221637. 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 Surgical Gown (Sterile); Surgical Gown (Non-sterile)?

Surgical Gown (Sterile); Surgical Gown (Non-sterile) is a medical device that received FDA 510(k) clearance on 2022-09-29. The listed applicant is Allmed Medical (Hubei) Protective Products Co., Ltd.. The 510(k) number is K221637.

When did Surgical Gown (Sterile); Surgical Gown (Non-sterile) receive FDA 510(k) clearance?

Surgical Gown (Sterile); Surgical Gown (Non-sterile) received FDA 510(k) clearance on 2022-09-29, under 510(k) number K221637.

Who is the listed applicant for Surgical Gown (Sterile); Surgical Gown (Non-sterile)?

The FDA 510(k) record lists Allmed Medical (Hubei) Protective Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Gown (Sterile); Surgical Gown (Non-sterile)?

The FDA product code for Surgical Gown (Sterile); Surgical Gown (Non-sterile) is FYA.

Other records listing Allmed Medical (Hubei) Protective Products Co., Ltd. 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.

K221027Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))

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

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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