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FDA 510(k)

Sterile Latex Surgical Gloves Powder Free

K-Number: K212848 · 2021-12-27

ApplicantPentavest Holdings Sdn Bhd
Decision Date2021-12-27
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Latex Surgical Gloves Powder Free is a medical device manufactured by Pentavest Holdings Sdn Bhd. It received FDA 510(k) clearance on 2021-12-27 under approval number K212848. 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 Latex Surgical Gloves Powder Free?

Sterile Latex Surgical Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2021-12-27. It is manufactured by Pentavest Holdings Sdn Bhd. The 510(k) number is K212848.

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

Sterile Latex Surgical Gloves Powder Free received FDA 510(k) clearance on 2021-12-27, under approval number K212848.

What company makes Sterile Latex Surgical Gloves Powder Free?

Sterile Latex Surgical Gloves Powder Free is manufactured by Pentavest Holdings Sdn Bhd.

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

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

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Other Devices by Pentavest Holdings Sdn Bhd

K212847Penta Glove

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

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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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