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FDA 510(k)

Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs

K-Number: K171898 · 2017-08-18

ApplicantBetter Care Plastic Technology Co., Ltd.
Decision Date2017-08-18
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Better Care Plastic Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K171898. 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 Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs?

Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Better Care Plastic Technology Co., Ltd.. The 510(k) number is K171898.

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

Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs received FDA 510(k) clearance on 2017-08-18, under 510(k) number K171898.

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

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

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

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

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Other records listing Better Care Plastic Technology 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.

K242533Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK232266Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK232070Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)K231567Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue)K223713Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)

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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

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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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