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FDA 510(k)

Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove

K-Number: K162852 · 2017-02-08

ApplicantLucenxia Prescience AG
Decision Date2017-02-08
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove is a medical device manufactured by Lucenxia Prescience AG. It received FDA 510(k) clearance on 2017-02-08 under approval number K162852. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove?

Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove is a medical device that received FDA 510(k) clearance on 2017-02-08. It is manufactured by Lucenxia Prescience AG. The 510(k) number is K162852.

When was Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove approved by the FDA?

Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove received FDA 510(k) clearance on 2017-02-08, under approval number K162852.

What company makes Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove?

Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove is manufactured by Lucenxia Prescience AG.

What is the FDA product code for Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove?

The FDA product code for Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove is KGO.

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Other Devices by Lucenxia Prescience AG

K171987Finessis Zero Flexylon Powder Free Sterile White Surgical Glove K173304Finessis Intense Polyisoprene Surgical Glove K173386Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs

Related Devices (Code: KGO)

K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)Hartalega Sdb. Bhd. K160974Gammex Cut-Resistant Glove LinerAnsell Healthcare Products, LLC K161008POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVEHartalega Sdn Bhd K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingCardinal Health, Inc. K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)Cardinal Health, Inc. K152428SensiCare PI Surgical GlovesMedline Industries, 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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