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Polymer Patient Examination Glove

FDA product code LZA · 1133 cleared devices

Class 1 General Hospital
Regulation
21 CFR 880.6250
Review panel
HO
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1984-05-22 – 2026-09-09

A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

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