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FDA 510(k)

LATEX EXAMINATION GLOVE POWDER FREE

K-Number: K161833 · 2017-05-23

ApplicantCareglove Global Sdn. Bhd.
Decision Date2017-05-23
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LATEX EXAMINATION GLOVE POWDER FREE is a medical device manufactured by Careglove Global Sdn. Bhd.. It received FDA 510(k) clearance on 2017-05-23 under approval number K161833. 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 LATEX EXAMINATION GLOVE POWDER FREE?

LATEX EXAMINATION GLOVE POWDER FREE is a medical device that received FDA 510(k) clearance on 2017-05-23. It is manufactured by Careglove Global Sdn. Bhd.. The 510(k) number is K161833.

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

LATEX EXAMINATION GLOVE POWDER FREE received FDA 510(k) clearance on 2017-05-23, under approval number K161833.

What company makes LATEX EXAMINATION GLOVE POWDER FREE?

LATEX EXAMINATION GLOVE POWDER FREE is manufactured by Careglove Global Sdn. Bhd..

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

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

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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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