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FDA 510(k)

Sterile Surgical Powder Free Latex Glove

K-Number: K221424 · 2023-01-26

ApplicantNew Era Medicare Sdn. Bhd.
Decision Date2023-01-26
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Surgical Powder Free Latex Glove is a medical device manufactured by New Era Medicare Sdn. Bhd.. It received FDA 510(k) clearance on 2023-01-26 under approval number K221424. 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 Surgical Powder Free Latex Glove?

Sterile Surgical Powder Free Latex Glove is a medical device that received FDA 510(k) clearance on 2023-01-26. It is manufactured by New Era Medicare Sdn. Bhd.. The 510(k) number is K221424.

When was Sterile Surgical Powder Free Latex Glove approved by the FDA?

Sterile Surgical Powder Free Latex Glove received FDA 510(k) clearance on 2023-01-26, under approval number K221424.

What company makes Sterile Surgical Powder Free Latex Glove?

Sterile Surgical Powder Free Latex Glove is manufactured by New Era Medicare Sdn. Bhd..

What is the FDA product code for Sterile Surgical Powder Free Latex Glove?

The FDA product code for Sterile Surgical Powder Free Latex Glove is KGO.

Related Clinical Trials

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Other Devices by New Era Medicare Sdn. Bhd.

K221667Non Sterile Powder Free Latex Examination Glove K230314Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)

Related Devices (Code: KGO)

K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)Hartalega Sdb. Bhd. K160974Gammex Cut-Resistant Glove LinerAnsell Healthcare Products, LLC K161008POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVEHartalega Sdn Bhd K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingCardinal Health, Inc. K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)Cardinal Health, Inc. K152428SensiCare PI Surgical GlovesMedline Industries, Inc.

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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