POWDER-FREE NITRILE EXAMINATION GLOVES— 510(k) K041276

Clearance details

Applicant

Shanghai Motex Healthcare Co., Ltd.

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2004-05-12

Decision date

2004-08-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Greer, SC, US

• 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
• K260794 — NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR2026-08-18
• K262014 — PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves2026-07-21

• K123126 — MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)2014-06-04
• K132802 — MOTEX POWDERED NITRILE SURGICAL GLOVES2014-05-21
• K122557 — MOTEX POWDER-FREE NITRILE SURGICAL GLOVES2013-10-03
• K063757 — MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES2007-07-27
• K030207 — NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #77352003-05-02

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 →