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FDA 510(k)

BOUNDARY SINGLE-USE GOWNS

K-Number: K822925 · 1983-01-12

ApplicantThe Buckeye Cellulose Corp.
Decision Date1983-01-12
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BOUNDARY SINGLE-USE GOWNS is the device name listed in this FDA 510(k) record. The listed applicant is The Buckeye Cellulose Corp.. It received FDA 510(k) clearance on 1983-01-12 under 510(k) number K822925. 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 BOUNDARY SINGLE-USE GOWNS?

BOUNDARY SINGLE-USE GOWNS is a medical device that received FDA 510(k) clearance on 1983-01-12. The listed applicant is The Buckeye Cellulose Corp.. The 510(k) number is K822925.

When did BOUNDARY SINGLE-USE GOWNS receive FDA 510(k) clearance?

BOUNDARY SINGLE-USE GOWNS received FDA 510(k) clearance on 1983-01-12, under 510(k) number K822925.

Who is the listed applicant for BOUNDARY SINGLE-USE GOWNS?

The FDA 510(k) record lists The Buckeye Cellulose Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOUNDARY SINGLE-USE GOWNS?

The FDA product code for BOUNDARY SINGLE-USE GOWNS is FYA.

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Other records listing The Buckeye Cellulose Corp. 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.

K823173ARRIRM SCRUB BRUSH/SPONGEK821564BOUNDARY PROCESS CHANGEK820758BOUNDARY SINGLE-USE CRANIOTOMY SHEETK820116BOUNDARYK813450BOUNDARY SINGLE-USE DRAPESK813390BONDARY SINGLE-USE OR GOWN

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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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