Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL) +2 more— 510(k) K240361

Clearance details

Device name as filed

Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)

Applicant

Hebei Titans Hongsen Medical Technology Co., Ltd.

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2024-02-06

Decision date

2024-04-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Xingtai, CN

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• K182043 — Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)2018-09-21

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →