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FDA 510(k)

LIFELINER SURGICAL GLOVE

K-Number: K910941 · 1991-05-09

ApplicantDepuy-Raynham
Decision Date1991-05-09
Product CodeFYE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIFELINER SURGICAL GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Depuy-Raynham. It received FDA 510(k) clearance on 1991-05-09 under 510(k) number K910941. The device is classified under product code FYE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFELINER SURGICAL GLOVE?

LIFELINER SURGICAL GLOVE is a medical device that received FDA 510(k) clearance on 1991-05-09. The listed applicant is Depuy-Raynham. The 510(k) number is K910941.

When did LIFELINER SURGICAL GLOVE receive FDA 510(k) clearance?

LIFELINER SURGICAL GLOVE received FDA 510(k) clearance on 1991-05-09, under 510(k) number K910941.

Who is the listed applicant for LIFELINER SURGICAL GLOVE?

The FDA 510(k) record lists Depuy-Raynham as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFELINER SURGICAL GLOVE?

The FDA product code for LIFELINER SURGICAL GLOVE is FYE.

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 Depuy-Raynham 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.

K914077REPEL(TM) LITE CUT RESISTANT GLOVE LINERSK900310REPEL SURGICAL GLOVE LINERS

Related Devices (Code: FYE)

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.

K932731BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWNJohnson & Johnson Medical, Inc.K912790SURGICAL GOWNUnicor Federal Dept. of JusticeK910920PROTEKT GLOVESIntermedics OrthopedicsK895667STERILE SURGICAL GOWNClinitech, Inc.K895235VARIOUS DISPOSABLE SURGICAL GARMENTSProtect Corp. of Indiana, Inc.K894760CLOTHINGUARDBarrier Concepts, 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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