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FDA 510(k)

GOWN, BOUNDARY SINGLE USE REINFORCED

K-Number: K760237 · 1976-08-11

ApplicantProcter & Gamble Mfg. Co.
Decision Date1976-08-11
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GOWN, BOUNDARY SINGLE USE REINFORCED is the device name listed in this FDA 510(k) record. The listed applicant is Procter & Gamble Mfg. Co.. It received FDA 510(k) clearance on 1976-08-11 under 510(k) number K760237. 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 GOWN, BOUNDARY SINGLE USE REINFORCED?

GOWN, BOUNDARY SINGLE USE REINFORCED is a medical device that received FDA 510(k) clearance on 1976-08-11. The listed applicant is Procter & Gamble Mfg. Co.. The 510(k) number is K760237.

When did GOWN, BOUNDARY SINGLE USE REINFORCED receive FDA 510(k) clearance?

GOWN, BOUNDARY SINGLE USE REINFORCED received FDA 510(k) clearance on 1976-08-11, under 510(k) number K760237.

Who is the listed applicant for GOWN, BOUNDARY SINGLE USE REINFORCED?

The FDA 510(k) record lists Procter & Gamble Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GOWN, BOUNDARY SINGLE USE REINFORCED?

The FDA product code for GOWN, BOUNDARY SINGLE USE REINFORCED is FYA.

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Other records listing Procter & Gamble Mfg. Co. as applicant

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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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