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Nitrile Cornflower Blue Powder-Free Examination Gloves With Tested For Use With…

FDA 510(k)

Class I (US FDA 510(k))

510(k) K103249

by Cardinalhealth

Identifiers

510(k) Number
K103249 FDA 510(k)
FDA Product Code
LZA FDA 510(k)

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 880.6250 FDA 510(k)
Regulation Number
880.6250 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Nitrile Cornflower Blue Powder-Free Examination Gloves With Tested For Use With… by Cardinalhealth — Class I — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cardinalhealth
FDA Applicant
Cardinal Health, Inc.

Sources (1)

  • FDA 510(k) K103249 24 fields · synced Jun 18, 2026