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FDA 510(k)

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)

K-Number: K223401 · 2023-03-07

ApplicantXiamen Probtain Medical Techology Co., Ltd.
Decision Date2023-03-07
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Probtain Medical Techology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-07 under 510(k) number K223401. 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 Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)?

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) is a medical device that received FDA 510(k) clearance on 2023-03-07. The listed applicant is Xiamen Probtain Medical Techology Co., Ltd.. The 510(k) number is K223401.

When did Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) receive FDA 510(k) clearance?

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) received FDA 510(k) clearance on 2023-03-07, under 510(k) number K223401.

Who is the listed applicant for Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)?

The FDA 510(k) record lists Xiamen Probtain Medical Techology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)?

The FDA product code for Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) is FYA.

Other records listing Xiamen Probtain Medical Techology 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.

K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)K202954Disposable Surgical MaskK201893Disposable Surgical 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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