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FDA 510(k)

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

K-Number: K171279 · 2017-10-12

ApplicantTop Glove Sdn. Bhd.
Decision Date2017-10-12
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Top Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K171279. 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 Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves?

Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Top Glove Sdn. Bhd.. The 510(k) number is K171279.

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

Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves received FDA 510(k) clearance on 2017-10-12, under 510(k) number K171279.

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

The FDA 510(k) record lists Top Glove Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Top Glove Sdn. Bhd. 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.

K192111Biodegradable Nitrile Examination Powder Free Glove, GreenK193150Latex Examination Powder Free Glove, Aloe VeraK172923Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue

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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