Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use wit…

FDA 510(k)

Class I (US FDA 510(k))

510(k) K213548

Identifiers

510(k) Number: K213548 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)

Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use wit… by Mercator Medical (Thailand) Ltd. — Class I — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K213548	Class I	Active

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Manufacturer

Manufacturer: Mercator Medical (Thailand) Ltd.
FDA Applicant: Mercator Medical (Thailand), Ltd.

Sources (1)

FDA 510(k) K213548 24 fields · synced Jun 18, 2026