# K223713: Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Better Care Plastic Technology Co., Ltd.
- Decided: Aug 7, 2023 after 238 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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) Summary page 5.

## Most influential descendants
- K233598: Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs (2024), 0 descendants of its own

## Indications for use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate. Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time (Minutes) Arsenic Trioxide (1 mg/ml) >240 Azacitidine (25 mg/ml) >240 Bendamustine HCL (5 mg/ml) >240 Bleomycin sulfate (15 mg/ml) >240 Bortezomib (1 mg/ml) >240 Busulfan (6 mg/ml) >240 Carboplatin (10 mg/ml) >240 Carfilzomib (2 mg/ml) >240 Carmustine (3.3 mg/ml) 13.9 Cetuximab (2 mg/ml) >240 Cisplatin (1 mg/ml) >240 Cyclophosphamide (20 mg/ml) >240 Cytarabine (Cytosine) (100 mg/ml) >240 Cytovene (10 mg/ml) >240 Dacarbazine (DTIC) (10 mg/ml) >240 Daunorubicin HCL (5 mg/ml) >240 Decitabine (5-Aza-2’-deoxycytidine) (5 mg/ml) >240 Docetaxel (10 mg/ml) >240 Doxorubicin Hydrochloride (2 mg/ml) >240 Epirubicin HCL(Ellence) (2 mg/ml) >240 Eribulin Mesylate (0.5 mg/ml) >240 Etoposide (Toposar) (20 mg/ml) >240 Fludarabine (25 mg/ml) >240 5-Fluorouracil (50 mg/ml) >240 Fulvestrant (50 mg/ml) >240 Gemcitabine (38 mg/ml) >240 Idarubicin (1.0 mg/ml) >240 Ifosfamide (50 mg/ml) >240 Irinotecan HCL (20 mg/ml) >240 Mechlorethamine HCL (1 mg/ml) >240 Melphalan (5 mg/ml) >240 Methotrexate (25 mg/ml) >240 Mitomycin-C (0.5 mg/ml) >240 Mitoxantrone (2 mg/ml) >240 Oxaliplatin (2 mg/ml) >240 Paclitaxel (6 mg/ml) >240 Paraplatin (10 mg/ml) >240 Pemetrexed (25 mg/ml) >240 Pertuzumab (30 mg/ml) >240 Raltitrexed monohydrate (0.5 mg/ml) >240 Retrovir (10 mg/ml) >240 Rituximab (10 mg/ml) >240 Temsirolimus (25 mg/ml) >240 Thiotepa (10 mg/ml) 44.4 Topotecan HCL (1 mg/ml) >240 Trastuzumab (21 mg/ml) >240 Trisenox (1 mg/ml) >240 Vinblastine (1 mg/ml) >240 Vincrinstine Sulfate (1 mg/ml) >240 Vinorelbine (10 mg/ml) >240 Zoledronic Acid (0.8 mg/ml) >240 Fentanyl Citrate and Concentration Minimum Breakthrough Detection Time (Minutes) Fentanyl Citrate Injection (100mcg/2mL) >240 Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution >240 *Please note that the following drugs have extremely low permeation times: Carmustine: 13.9 minutes, Thio Tepa: 44.4 minutes Warning: Do not use with Carmustine and Thio Tepa.

Source page: https://510kreport.com/device/K223713
Methodology: https://510kreport.com/methodology