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FDA 510(k)

PARADERM(TM) SURGEON'S GLOVE ACCESSORY

K-Number: K904903 · 1991-01-08

ApplicantLovell-Schenck, Inc.
Decision Date1991-01-08
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PARADERM(TM) SURGEON'S GLOVE ACCESSORY is the device name listed in this FDA 510(k) record. The listed applicant is Lovell-Schenck, Inc.. It received FDA 510(k) clearance on 1991-01-08 under 510(k) number K904903. 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 PARADERM(TM) SURGEON'S GLOVE ACCESSORY?

PARADERM(TM) SURGEON'S GLOVE ACCESSORY is a medical device that received FDA 510(k) clearance on 1991-01-08. The listed applicant is Lovell-Schenck, Inc.. The 510(k) number is K904903.

When did PARADERM(TM) SURGEON'S GLOVE ACCESSORY receive FDA 510(k) clearance?

PARADERM(TM) SURGEON'S GLOVE ACCESSORY received FDA 510(k) clearance on 1991-01-08, under 510(k) number K904903.

Who is the listed applicant for PARADERM(TM) SURGEON'S GLOVE ACCESSORY?

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

What is the FDA product code for PARADERM(TM) SURGEON'S GLOVE ACCESSORY?

The FDA product code for PARADERM(TM) SURGEON'S GLOVE ACCESSORY is LYU.

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.

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Other records listing Lovell-Schenck, 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.

K910890NON-STERILE CLINICAL STYLE PARADERM GLOVE LINER

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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