Thermoplastic Elastomer Examination (Tpe) Glove

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K172678 ↗

FDA Product Code

LZA

FDA applicant

Shen Wei USA, Inc.

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Shen Wei (Usa), Inc. →