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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 a medical device manufactured by Ineo Tech Sdn Bhd. It received FDA 510(k) clearance on 2023-09-29 under approval 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. It is manufactured by Ineo Tech Sdn Bhd. The 510(k) number is K231973.

When was PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove approved by the FDA?

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

What company makes PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove?

PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove is manufactured by Ineo Tech Sdn Bhd.

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 Clinical Trials

NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07595835 CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer RECRUITING NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING NCT06915454 High-Resolution PET-CT Imaging for Surgical Margin Visualization RECRUITING NCT07372638 Sensorised Surgical Gloves for Neuroendovascular Procedures NOT_YET_RECRUITING NCT06698458 Alpha Radiation Emitters Device (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer RECRUITING

Related Devices (Code: KGO)

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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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