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FDA 510(k)

Gammex PI Breach Detect Powder Free Surgical Glove

K-Number: K171375 · 2018-02-06

ApplicantAnsell Healthcare Products, LLC
Decision Date2018-02-06
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Gammex PI Breach Detect Powder Free Surgical Glove is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2018-02-06 under 510(k) number K171375. 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 Gammex PI Breach Detect Powder Free Surgical Glove?

Gammex PI Breach Detect Powder Free Surgical Glove is a medical device that received FDA 510(k) clearance on 2018-02-06. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K171375.

When did Gammex PI Breach Detect Powder Free Surgical Glove receive FDA 510(k) clearance?

Gammex PI Breach Detect Powder Free Surgical Glove received FDA 510(k) clearance on 2018-02-06, under 510(k) number K171375.

Who is the listed applicant for Gammex PI Breach Detect Powder Free Surgical Glove?

The FDA 510(k) record lists Ansell Healthcare Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gammex PI Breach Detect Powder Free Surgical Glove?

The FDA product code for Gammex PI Breach Detect Powder Free Surgical Glove is KGO.

Other records listing Ansell Healthcare Products, LLC 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.

K230079Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis PotentialK213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsK212148Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy DrugsK210401Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK200671Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested forK190018Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs

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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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