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FDA 510(k)

ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES

K-Number: K093300 · 2009-10-30

ApplicantCardinal Health, Inc.
Decision Date2009-10-30
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, Inc.. It received FDA 510(k) clearance on 2009-10-30 under 510(k) number K093300. 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 ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES?

ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES is a medical device that received FDA 510(k) clearance on 2009-10-30. The listed applicant is Cardinal Health, Inc.. The 510(k) number is K093300.

When did ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES receive FDA 510(k) clearance?

ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES received FDA 510(k) clearance on 2009-10-30, under 510(k) number K093300.

Who is the listed applicant for ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES?

The FDA 510(k) record lists Cardinal Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES?

The FDA product code for ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES is KGO.

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Other records listing Cardinal Health, Inc. 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.

K170198Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)K160411Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera CoatingK160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingK153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)K122696POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)K121897PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES

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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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