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FDA 510(k)

STERILE DISPOSABLE SURGICAL GOWNS

K-Number: K882470 · 1988-08-03

ApplicantBolden Products, Div. of the Transport Group
Decision Date1988-08-03
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE DISPOSABLE SURGICAL GOWNS is the device name listed in this FDA 510(k) record. The listed applicant is Bolden Products, Div. of the Transport Group. It received FDA 510(k) clearance on 1988-08-03 under 510(k) number K882470. 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 STERILE DISPOSABLE SURGICAL GOWNS?

STERILE DISPOSABLE SURGICAL GOWNS is a medical device that received FDA 510(k) clearance on 1988-08-03. The listed applicant is Bolden Products, Div. of the Transport Group. The 510(k) number is K882470.

When did STERILE DISPOSABLE SURGICAL GOWNS receive FDA 510(k) clearance?

STERILE DISPOSABLE SURGICAL GOWNS received FDA 510(k) clearance on 1988-08-03, under 510(k) number K882470.

Who is the listed applicant for STERILE DISPOSABLE SURGICAL GOWNS?

The FDA 510(k) record lists Bolden Products, Div. of the Transport Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE DISPOSABLE SURGICAL GOWNS?

The FDA product code for STERILE DISPOSABLE SURGICAL GOWNS is FYA.

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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.

K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation GownsPrinciple & Will Co., Ltd.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, LLC

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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