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FDA 510(k)

Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs

K-Number: K232444 · 2023-12-20

ApplicantGrand Work Plastic Products Co., Ltd.
Decision Date2023-12-20
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Grand Work Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K232444. 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 Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs?

Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Grand Work Plastic Products Co., Ltd.. The 510(k) number is K232444.

When did Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2023-12-20, under 510(k) number K232444.

Who is the listed applicant for Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Grand Work Plastic Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs?

The FDA product code for Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs is KGO.

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Other records listing Grand Work Plastic Products Co., Ltd. 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.

K232039Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK230217Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy DrugsK222892Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy DrugsK213574Nitrile Vinyl Blend Powder Free Examination Gloves (Black)K220249Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)K220250Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

View all 8 devices →

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.K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)Ansell Healthcare

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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