Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)— 510(k) K231643

Clearance details

Applicant

Syntex Healthcare Products Co., Ltd.

Product code

Product code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2023-06-05

Decision date

2023-09-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Xinji, CN

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• 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

• K240080 — Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate2024-04-02
• K103770 — SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL2011-04-21
• K102096 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE2010-10-04
• K052877 — POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE2005-11-08
• K042226 — SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY2004-09-30

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 →