Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate— 510(k) K232039

Clearance details

Applicant

Grand Work Plastic Products Co., Ltd.

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2023-07-10

Decision date

2023-08-09

Decision

Substantially Equivalent

Clearance type

Special

Location

Zanhuang County, CN

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• 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

• K232444 — Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs2023-12-20
• K230217 — Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs2023-05-13
• K222892 — Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs2022-12-15
• K213574 — Nitrile Vinyl Blend Powder Free Examination Gloves (Black)2022-07-12
• K220249 — Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)2022-05-26

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 →