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FDA 510(k)

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)

K-Number: K210143 · 2021-07-22

ApplicantFoshan Nanhai Plus Medical Co, Ltd.
Decision Date2021-07-22
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. It received FDA 510(k) clearance on 2021-07-22 under 510(k) number K210143. 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 Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)?

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) is a medical device that received FDA 510(k) clearance on 2021-07-22. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. The 510(k) number is K210143.

When did Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) receive FDA 510(k) clearance?

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) received FDA 510(k) clearance on 2021-07-22, under 510(k) number K210143.

Who is the listed applicant for Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)?

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

What is the FDA product code for Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)?

The FDA product code for Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) is FYA.

Related Clinical Trials

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.

NCT07063979Use of Transcutaneous Electrical Nerve Stimulation Device, Reletex Reliefband, With Current ERAS (Enhanced Recovery After Surgery) Protocol to Further Decrease Postoperative Nausea and Vomiting in the Bariatric Surgical Patient Within the First 24 Hours Postoperatively.RECRUITING

Other records listing Foshan Nanhai Plus Medical 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.

K222480Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)K213177Plus Medical Cover GownK211036Plus Medical Chemotherapy GownK212698Plus Medical Isolation Gown Level 3K212610Surgical Face 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

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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