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FDA 510(k)

ULTRATUFF CUT RESISTANT GLOVE LINER

K-Number: K925628 · 1993-07-09

ApplicantBaxter Healthcare Corp
Decision Date1993-07-09
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRATUFF CUT RESISTANT GLOVE LINER is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1993-07-09 under 510(k) number K925628. The device is classified under product code LYU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRATUFF CUT RESISTANT GLOVE LINER?

ULTRATUFF CUT RESISTANT GLOVE LINER is a medical device that received FDA 510(k) clearance on 1993-07-09. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K925628.

When did ULTRATUFF CUT RESISTANT GLOVE LINER receive FDA 510(k) clearance?

ULTRATUFF CUT RESISTANT GLOVE LINER received FDA 510(k) clearance on 1993-07-09, under 510(k) number K925628.

Who is the listed applicant for ULTRATUFF CUT RESISTANT GLOVE LINER?

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

What is the FDA product code for ULTRATUFF CUT RESISTANT GLOVE LINER?

The FDA product code for ULTRATUFF CUT RESISTANT GLOVE LINER is LYU.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: LYU)

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.

K011755STRYKER T4 HYTREL (R) TOGASStryker Corp.K965237NURSES BOUFFANT CAPCopioumed Intl., Inc.K970988FAR-EAST BOUFFANT CAPSFar East Science & Technology Development Co., Ltd.K964364DISPOSABLE APRONInstrument Makar, Inc.K961791DEPUY DISPOSABLE FILTER/HOODDepuy, Inc.K961454AMMI MAGNI-GUARDAmerican Medical Mfg., Inc.

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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