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FDA 510(k)

DISPOSABLE SHOE COVER

K-Number: K913628 · 1991-10-04

ApplicantGem Nonwovews, Inc.
Decision Date1991-10-04
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SHOE COVER is the device name listed in this FDA 510(k) record. The listed applicant is Gem Nonwovews, Inc.. It received FDA 510(k) clearance on 1991-10-04 under 510(k) number K913628. The device is classified under product code FXP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE SHOE COVER?

DISPOSABLE SHOE COVER is a medical device that received FDA 510(k) clearance on 1991-10-04. The listed applicant is Gem Nonwovews, Inc.. The 510(k) number is K913628.

When did DISPOSABLE SHOE COVER receive FDA 510(k) clearance?

DISPOSABLE SHOE COVER received FDA 510(k) clearance on 1991-10-04, under 510(k) number K913628.

Who is the listed applicant for DISPOSABLE SHOE COVER?

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

What is the FDA product code for DISPOSABLE SHOE COVER?

The FDA product code for DISPOSABLE SHOE COVER is FXP.

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 Gem Nonwovews, 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.

K913700DISPOSABLE BOUFFANT CAP

Related Devices (Code: FXP)

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.

K971076PRIMED SHOE COVERS, PRIMED HEAD COVERSPrimeline Medical Products, Inc.K971191FAR-EAST SHOE COVERSFar East Science & Technology Development Co., Ltd.K970815CONVERTORS IMPERVIOUS SHOE COVERSAllegiance Healthcare Corp.K961342SHOE COVER, NON-STERILECopioumed Intl., Inc.K955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHInstrument Makar, Inc.K952897NIOMED SHOE COVERSAmerasia Corp.

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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