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FDA 510(k)

Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less

K-Number: K162175 · 2016-11-21

ApplicantVietglove Corporation
Decision Date2016-11-21
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less is a medical device manufactured by Vietglove Corporation. It received FDA 510(k) clearance on 2016-11-21 under approval number K162175. 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 Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less?

Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less is a medical device that received FDA 510(k) clearance on 2016-11-21. It is manufactured by Vietglove Corporation. The 510(k) number is K162175.

When was Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less approved by the FDA?

Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less received FDA 510(k) clearance on 2016-11-21, under approval number K162175.

What company makes Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less?

Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less is manufactured by Vietglove Corporation.

What is the FDA product code for Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less?

The FDA product code for Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less is LYY.

Related Clinical Trials

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Other Devices by Vietglove Corporation

K153562Powder Free Blue Nitrile Examination Glove K170094POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED K201428Powder Free Black Nitrile Examination Glove

Related Devices (Code: LYY)

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 K161833LATEX EXAMINATION GLOVE POWDER FREECareglove Global Sdn. Bhd.

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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