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FDA 510(k)

POWDER FREE LATEX EXAMINATION GLOVE

K-Number: K173053 · 2018-06-06

ApplicantProfessional Latex Sdn Bhd
Decision Date2018-06-06
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER FREE LATEX EXAMINATION GLOVE is a medical device manufactured by Professional Latex Sdn Bhd. It received FDA 510(k) clearance on 2018-06-06 under approval number K173053. 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?

POWDER FREE LATEX EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 2018-06-06. It is manufactured by Professional Latex Sdn Bhd. The 510(k) number is K173053.

When was POWDER FREE LATEX EXAMINATION GLOVE approved by the FDA?

POWDER FREE LATEX EXAMINATION GLOVE received FDA 510(k) clearance on 2018-06-06, under approval number K173053.

What company makes POWDER FREE LATEX EXAMINATION GLOVE?

POWDER FREE LATEX EXAMINATION GLOVE is manufactured by Professional Latex Sdn Bhd.

What is the FDA product code for POWDER FREE LATEX EXAMINATION GLOVE?

The FDA product code for POWDER FREE LATEX EXAMINATION GLOVE is LYY.

Related Clinical Trials

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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

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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