Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy— 510(k) K213548

Clearance details

Applicant

Mercator Medical (Thailand), Ltd.

Product code

Product code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2021-11-08

Decision date

2022-02-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Amphur Rattaphum, TH

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• K251141 — Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more2025-11-17
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• K192444 — mCare® Powder Free Nitrile Black Examination Glove2019-12-31
• K190876 — mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed2019-12-02
• K172930 — mCare Powder-free Blue Nitrile Examination Gloves2018-04-13

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 →