Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS

K-Number: K923815 · 1993-03-31

ApplicantLaivan Corp.
Decision Date1993-03-31
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS is the device name listed in this FDA 510(k) record. The listed applicant is Laivan Corp.. It received FDA 510(k) clearance on 1993-03-31 under 510(k) number K923815. 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 TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS?

TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS is a medical device that received FDA 510(k) clearance on 1993-03-31. The listed applicant is Laivan Corp.. The 510(k) number is K923815.

When did TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS receive FDA 510(k) clearance?

TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS received FDA 510(k) clearance on 1993-03-31, under 510(k) number K923815.

Who is the listed applicant for TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS?

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

What is the FDA product code for TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS?

The FDA product code for TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Laivan 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.

K890940MODIFIED LABELING FOR POLYDERM WBC(TM)K885205AQUADERMK880153POLYDERM A+B(TM)K880964POLYDERM PEC(TM), POROUS ELASTIC COVERK880206POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER

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.

↑