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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Disposable Nitrile Examination Glove (Black/ Lilac/ Navy Blue/Burgundy); FifthPulse Medical Examination Nitrile Gloves Burgundy; FifthPulse Medical Examination Nitrile Gloves Lilac; FifthPulse Medical Examination Nitrile Gloves Navy Blue
Classification Name: POLYMER PATIENT EXAMINATION GLOVE
Product Code: LZA
Device Class: 1
Regulation Number: 880.6250
Medical Specialty: General Hospital
Registered Establishment Name: JIANGSU CUREGUARD GLOVE CO., LTD.
Registered Establishment Number: 3006534695
Premarket Submission Number: K213121
Owner/Operator: JIANGSU CUREGUARD GLOVE CO., LTD.
Owner/Operator Number: 9096440
Establishment Operations: Manufacturer
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