# 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

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Intco Medical Products Co., Ltd.
- Decided: Jan 26, 2024 after 78 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: 4 generations back to K183287 (2019). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223713: Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Better Care Plastic Technology Co., Ltd. (2023) Summary page 6.

## Indications for use
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs is a disposable device intended for medical purposes 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, Fentanyl Citrate, and Select Other Drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Test Chemotherapy drug & Concentration Minimum Breakthrough Detection Times (Minutes) Bendamustine HCI; 5 mg/ml >240 Bleomycin sulfate; 15 mg/ml >240 Busulfan ; 6 mg/ml >240 Carboplatin;10 mg/ml >240. Carfilzomib; 2 mg/ml >240 Carmustine; 3.3 mg/ml 1.7 Cetuximab ; 2 mg/ml >240 Cisplatin; 1 mg/ml >240 Cladribine; 1 mg/ml >240 Cyclophosphamide; 20 mg/ml >240 Cytarabine ( Cytosine); 100 mg/ml >240 Cytovene (Ganciclovir); 10 mg/ml >240 Dacarbazine; 10 mg/ml >240 Daunorubicin HCL; 5 mg/ml >240 Decitabine; 5 mg/ml >240 Docetaxel; 20 mg/ml >240 Doxorubicin HCL; 2 mg/ml >240 Epirubicin HCL; 2 mg/ml >240 Etoposide; 20 mg/ml >240 Fludarabine Phosphate; 25 mg/ml >240 Fluorouracil; 50 mg/ml >240 Fulvestrant; 50 mg/ml >240 Gemcitabine HCI; 38 mg/ml >240 Idarubicin HCI; 1 mg/ml >240 Ifosfamide; 50 mg/ml >240 Irinotecan HCI ; 20 mg/ml >240 Mechlorethamine HCL; 1 mg/ml >240 Melphalan HCI; 5 mg/ml >240 Methotrexate ; 25 mg/ml >240 Mitomycin C; 0.5 mg/ml >240 Mitoxantrone HCI; 2 mg/ml >240 Oxaliplatin; 5 mg/ml >240 Pacilitaxel; 6 mg/ml >240 Pemetrexed; 25 mg/ml >240 Rituximab; 10 mg/ml >240 ThioTepa; 10 mg/ml 0 Topotecan HCL; 1 mg/ml >240 Trisonex; 1 mg/ml >240 Velcade (Bortezomib); 1 mg/ml >240 Vidaza (Azacytidine) ; 25 mg/ml >240 Vincrinstine Sulfate; 1 mg/ml >240 Vinorelbine Tartrate; 10 mg/ml >240 Zoledronic Acid; 0.8 mg/ml >240 Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 1.7 minutes and Thiotepa:0 minute Warning: Do not use with Carmustine and Thiotepa Fentanyl Citrate & Other Drugs Minimum Breakthrough Detection Times Fentanyl Citrate Injection(100 mcg/2ml) >240 Chloroquine; 50mg/ml >240 Cyclosporin A; 100mg/mi >240 Retrovir; 10 mg/ml >240

Source page: https://510kreport.com/device/K233598
Methodology: https://510kreport.com/methodology