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FDA 510(k)

Finessis Zero Flexylon Powder Free Sterile White Surgical Glove

K-Number: K171987 · 2017-10-20

Decision Date2017-10-20
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Finessis Zero Flexylon Powder Free Sterile White 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 2017-10-20 under 510(k) number K171987. 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 Flexylon Powder Free Sterile White Surgical Glove?

Finessis Zero Flexylon Powder Free Sterile White Surgical Glove is a medical device that received FDA 510(k) clearance on 2017-10-20. The listed applicant is Lucenxia Prescience AG. The 510(k) number is K171987.

When did Finessis Zero Flexylon Powder Free Sterile White Surgical Glove receive FDA 510(k) clearance?

Finessis Zero Flexylon Powder Free Sterile White Surgical Glove received FDA 510(k) clearance on 2017-10-20, under 510(k) number K171987.

Who is the listed applicant for Finessis Zero Flexylon Powder Free Sterile White 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 Zero Flexylon Powder Free Sterile White Surgical Glove?

The FDA product code for Finessis Zero Flexylon Powder Free Sterile White 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.

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.

Official Source

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