GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemothera…

FDA 510(k)

Class I (US FDA 510(k))

510(k) K240545

Identifiers

510(k) Number: K240545 FDA 510(k)
FDA Product Code: LZA FDA 510(k)
Models / Variants: XS FDA 510(k)
S FDA 510(k)
M FDA 510(k)
L FDA 510(k)
XL 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)

GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemothera… by Genabio Diagnostics Inc. — Class I — FDA_510K — listed in FDA 510(k) — 5…

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	K240545	Class I	Active

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Manufacturer

Manufacturer: Genabio Diagnostics Inc.
FDA Applicant: Genabio Diagnostics, Inc.

Sources (1)

FDA 510(k) K240545 24 fields · synced Jun 18, 2026