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FDA 510(k)

Blue Latex Examination Powder Free Gloves

K-Number: K192329 · 2019-11-25

ApplicantJr Engineering & Medical Technologies (M) Sdn. Bhd.
Decision Date2019-11-25
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Blue Latex Examination Powder Free Gloves is a medical device manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2019-11-25 under approval number K192329. 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 Blue Latex Examination Powder Free Gloves?

Blue Latex Examination Powder Free Gloves is a medical device that received FDA 510(k) clearance on 2019-11-25. It is manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K192329.

When was Blue Latex Examination Powder Free Gloves approved by the FDA?

Blue Latex Examination Powder Free Gloves received FDA 510(k) clearance on 2019-11-25, under approval number K192329.

What company makes Blue Latex Examination Powder Free Gloves?

Blue Latex Examination Powder Free Gloves is manufactured by Jr Engineering & Medical Technologies (M) Sdn. Bhd..

What is the FDA product code for Blue Latex Examination Powder Free Gloves?

The FDA product code for Blue Latex Examination Powder Free Gloves 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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