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FDA 510(k)

CARETEX ISOLUTION GOWNS

K-Number: K864479 · 1986-12-09

ApplicantJames River Corp.
Decision Date1986-12-09
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CARETEX ISOLUTION GOWNS 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 1986-12-09 under 510(k) number K864479. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARETEX ISOLUTION GOWNS?

CARETEX ISOLUTION GOWNS is a medical device that received FDA 510(k) clearance on 1986-12-09. The listed applicant is James River Corp.. The 510(k) number is K864479.

When did CARETEX ISOLUTION GOWNS receive FDA 510(k) clearance?

CARETEX ISOLUTION GOWNS received FDA 510(k) clearance on 1986-12-09, under 510(k) number K864479.

Who is the listed applicant for CARETEX ISOLUTION GOWNS?

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 ISOLUTION GOWNS?

The FDA product code for CARETEX ISOLUTION GOWNS is FYC.

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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 DRESSINGK894034MODIFIED LABELING OF SURGICAL GLOVESK892580CARETOUCH EXAMINATION GLOVESK893939ISOLATION MASKSK890459JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES

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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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