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)

BARRIER SURGICAL GOWNS

K-Number: K050786 · 2005-05-09

ApplicantMolnlycke Health Care
Decision Date2005-05-09
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARRIER SURGICAL GOWNS is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care. It received FDA 510(k) clearance on 2005-05-09 under 510(k) number K050786. 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 BARRIER SURGICAL GOWNS?

BARRIER SURGICAL GOWNS is a medical device that received FDA 510(k) clearance on 2005-05-09. The listed applicant is Molnlycke Health Care. The 510(k) number is K050786.

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

BARRIER SURGICAL GOWNS received FDA 510(k) clearance on 2005-05-09, under 510(k) number K050786.

Who is the listed applicant for BARRIER SURGICAL GOWNS?

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

What is the FDA product code for BARRIER SURGICAL GOWNS?

The FDA product code for BARRIER 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 Molnlycke Health Care 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.

K123892MEPILEX TRANSFER AGK122132AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAMK102923BARRIER N95 PARTICULATE RESPIRATORK100029MEPILEX BORDER AG DRESSINGK061554MEPILEX AG ABSORBENT SILICONE-COATED DRESSINGK031131KLINIDRAPE SURGICAL DRAPES

View all 7 devices →

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.

↑