Biogel Sensor Surgeon's Glove with Non-Pyrogenic Statement

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K071700 ↗

FDA Product Code

KGO

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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