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FDA 510(k)

Finessis Intense Polyisoprene Surgical Glove

K-Number: K173304 · 2018-04-30

ApplicantLucenxia Prescience AG
Decision Date2018-04-30
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Finessis Intense Polyisoprene Surgical Glove is the device name listed in this FDA 510(k) record. The listed applicant is Lucenxia Prescience AG. It received FDA 510(k) clearance on 2018-04-30 under 510(k) number K173304. 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 Intense Polyisoprene Surgical Glove?

Finessis Intense Polyisoprene Surgical Glove is a medical device that received FDA 510(k) clearance on 2018-04-30. The listed applicant is Lucenxia Prescience AG. The 510(k) number is K173304.

When did Finessis Intense Polyisoprene Surgical Glove receive FDA 510(k) clearance?

Finessis Intense Polyisoprene Surgical Glove received FDA 510(k) clearance on 2018-04-30, under 510(k) number K173304.

Who is the listed applicant for Finessis Intense Polyisoprene Surgical Glove?

The FDA 510(k) record lists Lucenxia Prescience AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Finessis Intense Polyisoprene Surgical Glove?

The FDA product code for Finessis Intense Polyisoprene Surgical Glove is KGO.

Other records listing Lucenxia Prescience AG 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.

K173386Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy DrugsK171987Finessis Zero Flexylon Powder Free Sterile White Surgical GloveK162852Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove

Related Devices (Code: KGO)

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.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

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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