Latex Powder-Free Examination Gloves with Coating

by Cardinalhealth 510(k)

Active United States

510(k) K033789

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK033789	Date7 May 2004Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K033789
FDA Product Code: LZC

Device Class: Class I
Regulation: 21 CFR Part 880.6250
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

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