MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES— 510(k) K040176

Clearance details

Applicant

Maxter Glove Manufacturing Sdn Bhd

Product code

Product code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2004-01-26

Decision date

2004-02-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Meru, Klang, MY

• K253508 — Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile2026-10-29
• K262208 — Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid +2 more2026-10-01
• K261793 — Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)2026-09-09
• K262542 — Biodegradable Nitrile Powder Free Examination Glove, Green +1 more2026-09-09
• K260312 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim +1 more2026-09-08

• K172864 — Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs2018-05-02
• K151390 — Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs2016-05-02
• K113100 — POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS2012-02-06
• K032501 — MAXTER STERILE POWDER FREE SURGICAL GLOVES2003-10-17
• K032467 — MAXTER STERILE POWDERED LATEX SURGICAL GLOVES2003-10-10

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 →