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FDA 510(k)

CARETEX SKID RESISTANT SHOE COVERS

K-Number: K880093 · 1988-01-29

ApplicantJames River Corp.
Decision Date1988-01-29
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CARETEX SKID RESISTANT SHOE COVERS is the device name listed in this FDA 510(k) record. The listed applicant is James River Corp.. It received FDA 510(k) clearance on 1988-01-29 under 510(k) number K880093. 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 CARETEX SKID RESISTANT SHOE COVERS?

CARETEX SKID RESISTANT SHOE COVERS is a medical device that received FDA 510(k) clearance on 1988-01-29. The listed applicant is James River Corp.. The 510(k) number is K880093.

When did CARETEX SKID RESISTANT SHOE COVERS receive FDA 510(k) clearance?

CARETEX SKID RESISTANT SHOE COVERS received FDA 510(k) clearance on 1988-01-29, under 510(k) number K880093.

Who is the listed applicant for CARETEX SKID RESISTANT SHOE COVERS?

The FDA 510(k) record lists James River Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARETEX SKID RESISTANT SHOE COVERS?

The FDA product code for CARETEX SKID RESISTANT SHOE COVERS is FXP.

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Other records listing James River Corp. 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.

K894505COTOLIN DRAIN SPONGE AND DRESSING SPONGEK894147VISULIN TRANSPARENT ADHESIVE DRESSINGK892580CARETOUCH EXAMINATION GLOVESK893939ISOLATION MASKSK894034MODIFIED LABELING OF SURGICAL GLOVESK890459JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES

View all 15 devices →

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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