powder free nitrile examination glove - white, non-sterile— 510(k) K212802

Clearance details

Applicant

Hong Seng Gloves Sdn Bhd

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2021-09-02

Decision date

2021-12-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sungai Petani, MY

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• K262014 — PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves2026-07-21

• K221164 — Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl2022-08-30
• K212801 — Powder free nitrile examination glove- black, non sterile2022-01-09
• K212804 — Powder free nitrile examination glove- blue, non-sterile2021-12-01

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 →