510(k) clearance

Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile

FDA 510(k) source

510(k) number

K253508

Applicant

Vietglove Corporation

Decision date

Oct 29, 2026

Date received

Nov 3, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

LZA

Device type

Polymer Patient Examination Glove

Device class

Class I

Regulation

21 CFR 880.6250

Advisory committee

General Hospital

Statement or summary

Summary

Third party

N

Location

Ho Chi Minh, VN