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FDA 510(k)

GLOBAL HEALTHCARE FACE MASK

K-Number: K953754 · 1996-01-26

ApplicantGlobal Healthcare, Inc.
Decision Date1996-01-26
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GLOBAL HEALTHCARE FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Global Healthcare, Inc.. It received FDA 510(k) clearance on 1996-01-26 under 510(k) number K953754. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOBAL HEALTHCARE FACE MASK?

GLOBAL HEALTHCARE FACE MASK is a medical device that received FDA 510(k) clearance on 1996-01-26. The listed applicant is Global Healthcare, Inc.. The 510(k) number is K953754.

When did GLOBAL HEALTHCARE FACE MASK receive FDA 510(k) clearance?

GLOBAL HEALTHCARE FACE MASK received FDA 510(k) clearance on 1996-01-26, under 510(k) number K953754.

Who is the listed applicant for GLOBAL HEALTHCARE FACE MASK?

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

What is the FDA product code for GLOBAL HEALTHCARE FACE MASK?

The FDA product code for GLOBAL HEALTHCARE FACE MASK is FXX.

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 Global Healthcare, Inc. 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.

K990567GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCHK954549SURGICAL APPAREL

Related Devices (Code: FXX)

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.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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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