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FDA 510(k)

ComfortGuard Surgical Gown, i600, Film Reinforced

K-Number: K163191 · 2017-02-27

ApplicantGri Medical & Electrical Technology Co., Ltd.
Decision Date2017-02-27
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ComfortGuard Surgical Gown, i600, Film Reinforced is the device name listed in this FDA 510(k) record. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-02-27 under 510(k) number K163191. 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 ComfortGuard Surgical Gown, i600, Film Reinforced?

ComfortGuard Surgical Gown, i600, Film Reinforced is a medical device that received FDA 510(k) clearance on 2017-02-27. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. The 510(k) number is K163191.

When did ComfortGuard Surgical Gown, i600, Film Reinforced receive FDA 510(k) clearance?

ComfortGuard Surgical Gown, i600, Film Reinforced received FDA 510(k) clearance on 2017-02-27, under 510(k) number K163191.

Who is the listed applicant for ComfortGuard Surgical Gown, i600, Film Reinforced?

The FDA 510(k) record lists Gri Medical & Electrical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ComfortGuard Surgical Gown, i600, Film Reinforced?

The FDA product code for ComfortGuard Surgical Gown, i600, Film Reinforced is FYA.

Other records listing Gri Medical & Electrical Technology 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.

K172445RoyalGuard Surgical Gown, i600, BreathableK162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500

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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