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FDA 510(k)

ACTIPROTECT UF N95 RESPIRATOR

K-Number: K093161 · 2010-05-10

ApplicantGlaxosmithkline Consumer Healthcare
Decision Date2010-05-10
Product CodeONT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACTIPROTECT UF N95 RESPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Glaxosmithkline Consumer Healthcare. It received FDA 510(k) clearance on 2010-05-10 under 510(k) number K093161. The device is classified under product code ONT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIPROTECT UF N95 RESPIRATOR?

ACTIPROTECT UF N95 RESPIRATOR is a medical device that received FDA 510(k) clearance on 2010-05-10. The listed applicant is Glaxosmithkline Consumer Healthcare. The 510(k) number is K093161.

When did ACTIPROTECT UF N95 RESPIRATOR receive FDA 510(k) clearance?

ACTIPROTECT UF N95 RESPIRATOR received FDA 510(k) clearance on 2010-05-10, under 510(k) number K093161.

Who is the listed applicant for ACTIPROTECT UF N95 RESPIRATOR?

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

What is the FDA product code for ACTIPROTECT UF N95 RESPIRATOR?

The FDA product code for ACTIPROTECT UF N95 RESPIRATOR is ONT.

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 Glaxosmithkline Consumer Healthcare 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.

K093189ACTIPROTECT UC N95 RESPIRATORK081923ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD

Related Devices (Code: ONT)

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.

K122702BIOFRIEND BIOMASK N95 SURGICAL RESPIRATORFilligent LimitedK120244SPECTRASHIELD 9500 SURGICAL N95 RESPIRATORNexera Medical, Inc.K090414SPECTRASHIELD 9500 SURGICAL MASKNexera Medical, Inc.K081923ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLDGlaxosmithkline Consumer Healthcare

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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