# K222181: Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Iconic Medicare Sdn Bhd
- Decided: Jan 11, 2023 after 173 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K183287 (2019). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221269: Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Better Care Plastic Technology Co., Ltd. (2022). Cleared while this submission was under review Summary page 5.

## Indications for use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2019). The following chemicals have been tested with these gloves. S.No Chemotherapy Drugs Concentration Minimum Breakthrough Detection Time (Specimen 1,2,3) (Minutes) 1 Carboplatin, 10 mg/ml (10,000 ppm) >240 min. 2 Carmustine, 3.3 mg/ml (3,300 ppm) 26.6 (27.5,26.6,26.8) 3 Cisplatin, 1 mg/ml (1,000 ppm) >240 min. 4 Cyclophosphamide, 20 mg/ml (20,000 ppm) >240 min. 5 Dacarbazine, 10 mg/ml (10,000 ppm) >240 min. 6 Doxorubicin HCI, 2 mg/ml (2,000 ppm) >240 min. 7 Etoposide, 20 mg/ml (20,000 ppm) >240 min. 8 Fluorouracil, 50 mg/ml (50,000 ppm) >240 min. 9 Methotrexate, 25 mg/ml (25,000 ppm) >240 min. 10 Mitomycin C, 0.5 mg/ml (500 ppm) >240 min. 11 Mitoxantrone, 2 mg/ml (2,000 ppm) >240 min. 12 Oxaliplatin, 5 mg/ml (5,000 ppm) >240 min. 13 Paclitaxel, 6 mg/ml (6,000 ppm) >240 min. 14 Thiotepa, 10 mg/ml (10,000 ppm) 56.0 (58.4,56.5,56.0) 15 Vincristine Sulfate, 1 mg/ml (1,000 ppm) >240 min. S.No Opiod Drugs Concentration Minimum Breakthrough Detection Time (Specimen 1,2,3) (Minutes) 16 Fentanyl Citrate Injection 100mcg/2mL >240 min. Please note that the following drugs have low permeation times: Carmustine: 26.6 minutes Thiotepa: 56.0 minutes Warning - Please do not use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K222181
Methodology: https://510kreport.com/methodology