FDA 510(k)

Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves

K-Number: K213775 · 2022-04-24

Decision Date2022-04-24

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves is a medical device manufactured by Avecena Gloves Sdn Bhd. It received FDA 510(k) clearance on 2022-04-24 under approval number K213775. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves?

Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves is a medical device that received FDA 510(k) clearance on 2022-04-24. It is manufactured by Avecena Gloves Sdn Bhd. The 510(k) number is K213775.

When was Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves approved by the FDA?

Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves received FDA 510(k) clearance on 2022-04-24, under approval number K213775.

What company makes Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves?

Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves is manufactured by Avecena Gloves Sdn Bhd.

What is the FDA product code for Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves?

The FDA product code for Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves is LYY.

Related Devices (Code: LYY)

K162175Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or lessVietglove Corporation K161006Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of GloveHartalega Sdn Bhd K153744A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)A1 Glove Sdn Bhd K152593LATEX EXAMINATION GLOVE POWDER FREECareplus (M) Sdn Bhd K170094POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATEDVietglove Corporation K170779Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable proteinTerang Nusa Sdn Bhd

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.