Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl— 510(k) K192954

Clearance details

Applicant

Comfort Rubber Gloves Industries Sdn. Bhd.

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2019-10-21

Decision date

2020-06-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Matang, MY

• 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

• K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein2025-04-29
• K240269 — Nitrile Powder Free Examination Gloves Biodegradable (Green)2024-10-25
• K241528 — Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential2024-08-06
• K200181 — Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate2020-04-15
• K190080 — Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)2019-06-27

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 →