SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

• • Ongoing Z-0317-2022 FDA Class II ·initiated 27 Sep 2021 ·on shared 510(k) K182851

  All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K182851 ↗

FDA Product Code

LZA

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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