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BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHE — Brightway Holdings Sdn. Bhd. (510(k)

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHE — Brightway Holdings Sdn. Bhd. (510(k) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHE; Applicant

Device nameBRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHE
ApplicantBrightway Holdings Sdn. Bhd.
Clearance track510(k)
Submission numberK162186
DecisionSubstantially Equivalent
Decision date2017-03-31
Date received2016-08-04
Product codeLZC
Device class1
Medical specialtyGeneral Hospital
Applicant locationMY
SourceopenFDA device

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