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FDA 510(k)

STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING

K-Number: K113707 · 2012-04-27

ApplicantCardinal Health-Medical Products and Services
Decision Date2012-04-27
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health-Medical Products and Services. It received FDA 510(k) clearance on 2012-04-27 under 510(k) number K113707. 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 STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING?

STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING is a medical device that received FDA 510(k) clearance on 2012-04-27. The listed applicant is Cardinal Health-Medical Products and Services. The 510(k) number is K113707.

When did STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING receive FDA 510(k) clearance?

STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING received FDA 510(k) clearance on 2012-04-27, under 510(k) number K113707.

Who is the listed applicant for STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING?

The FDA 510(k) record lists Cardinal Health-Medical Products and Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING?

The FDA product code for STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING is KGO.

Related Clinical Trials

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.

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Other records listing Cardinal Health-Medical Products and Services 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.

K132060DURABLUE STERILIZATION WRAPK123289DURABLUE STERILIZATION WRAPK120542CARDINAL HEALTH DURABLUE STERILIZATION WRAPK111868STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATINGK983962ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES

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

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

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