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)

AOR-SULLIVAN PROTECTIVE OVERGLOVE

K-Number: K893118 · 1989-06-01

ApplicantAor-Sullivan
Decision Date1989-06-01
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AOR-SULLIVAN PROTECTIVE OVERGLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Aor-Sullivan. It received FDA 510(k) clearance on 1989-06-01 under 510(k) number K893118. The device is classified under product code LYU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AOR-SULLIVAN PROTECTIVE OVERGLOVE?

AOR-SULLIVAN PROTECTIVE OVERGLOVE is a medical device that received FDA 510(k) clearance on 1989-06-01. The listed applicant is Aor-Sullivan. The 510(k) number is K893118.

When did AOR-SULLIVAN PROTECTIVE OVERGLOVE receive FDA 510(k) clearance?

AOR-SULLIVAN PROTECTIVE OVERGLOVE received FDA 510(k) clearance on 1989-06-01, under 510(k) number K893118.

Who is the listed applicant for AOR-SULLIVAN PROTECTIVE OVERGLOVE?

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

What is the FDA product code for AOR-SULLIVAN PROTECTIVE OVERGLOVE?

The FDA product code for AOR-SULLIVAN PROTECTIVE OVERGLOVE is LYU.

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 Aor-Sullivan 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.

K902016MODIFIED AOR-SULLIVAN PROTECTIVE OVERGLOVE

Related Devices (Code: LYU)

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.

K011755STRYKER T4 HYTREL (R) TOGASStryker Corp.K965237NURSES BOUFFANT CAPCopioumed Intl., Inc.K970988FAR-EAST BOUFFANT CAPSFar East Science & Technology Development Co., Ltd.K964364DISPOSABLE APRONInstrument Makar, Inc.K961791DEPUY DISPOSABLE FILTER/HOODDepuy, Inc.K961454AMMI MAGNI-GUARDAmerican Medical Mfg., Inc.

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.

↑