FDA 510(k)

BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE

K-Number: K053102 · 2006-03-10

Decision Date2006-03-10

Product CodeKGO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Regent Medical Americas, LLC. It received FDA 510(k) clearance on 2006-03-10 under 510(k) number K053102. 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 BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE?

BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE is a medical device that received FDA 510(k) clearance on 2006-03-10. The listed applicant is Regent Medical Americas, LLC. The 510(k) number is K053102.

When did BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE receive FDA 510(k) clearance?

BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE received FDA 510(k) clearance on 2006-03-10, under 510(k) number K053102.

Who is the listed applicant for BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE?

The FDA 510(k) record lists Regent Medical Americas, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE?

The FDA product code for BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE is KGO.

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Other records listing Regent Medical Americas, LLC as applicant

K053441BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE K053442BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE K053443BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE K050899BIOGEL LATEX STERILE POWDER-FREE GLOVE K050533ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE K050184BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE

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Related Devices (Code: KGO)

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 Limited K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbH K240790Polyisoprene 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.