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FDA 510(k)

PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove

K-Number: K231973 · 2023-09-29

ApplicantIneo Tech Sdn Bhd
Decision Date2023-09-29
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove is the device name listed in this FDA 510(k) record. The listed applicant is Ineo Tech Sdn Bhd. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K231973. 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 PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove?

PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Ineo Tech Sdn Bhd. The 510(k) number is K231973.

When did PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove receive FDA 510(k) clearance?

PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove received FDA 510(k) clearance on 2023-09-29, under 510(k) number K231973.

Who is the listed applicant for PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove?

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

What is the FDA product code for PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove?

The FDA product code for PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove is KGO.

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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