# K211604: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Shanxi Hongjin Plastic Technology Co., Ltd.
- Decided: Oct 27, 2021 after 155 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: 7 generations back to K042805 (2004). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182600: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue), Better Care Plastic Technology Co., Ltd. (2018) Summary page 5.

## Indications for use
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs 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 using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results. Chemotherapy Drug Permeation The following chemicals have been tested with these gloves: * Please note that the following drugs have extremely low permeation times: Chemotherapy Drug Minimum BDT (Minutes) Bleomycin (15.0mg/ml) >240 Bortezomib (Velcade) lmg/ml >240 Busulfan (6.0mg/ml) >240 Carboplatin, (10.0mg/ml) >240 Carmustine(BCNU) (3.3 mg/ml) 7.0 Chloroquine, (50.0mg/ml) >240 Cisplatin (lmg/ml) >240 Cyclophosphamide (Cytoxan) (20mg/ml) >240 Cyclosporin, (100.Omg/ml) >240 Cytarabine, (100.0mg/ml) >240 Dacarbazine (10mg/ml) >240 Daunorubicin, HCL (5.Omg/ml) >240 Docetaxel, (10.Omg/ml) >240 Doxorubicin HCL (2mg/ml) >240 Epirubicin HCL (Ellence), (2.0mg/ml) >240 Etoposide (20mg/ml) >240 Fludarabine, (25.0mg/ml) >240 Fluorouracil (50mg/ml) >240 Gemcitabine (38.0mg/ml) >240 Idarubicin HCL (1.0mg/ml) >240 Ifosfamide, (50.Omg/ml) >240 Irinotecan, (20.0mg/ml) >240 Mechlorethamine HCI, (1.0mg/ml) >240 Melphalan, (5.0mg/ml) >240 Methotrexate (25mg/ml) >240 Mitomycin C, (0.5mg/ml) >240 Mitoxantrone, (2.0mg/ml) >240 Oxaliplatin, (5.Omg/ml) >240 Paclitaxel (Taxol) (6mg/ml) >240 Paraplatin, (10.0mg/ml) >240 Retrovir, (10.0mg/ml) >240 Rituximab, (10.0mg/ml) >240 Thio Tepa (10mg/ml) 23.0 Topotecan HCL, (1.0mg/ml) >240 Trisonex, (1.0mg/ml) >240 Vincristine, (1.0mg/ml) >240 Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 7.0 minutes, Thio Tepa: 23 minutes, Warning: Do not use with Carmustine (BCNU) and Thio Tepa.

Source page: https://510kreport.com/device/K211604
Methodology: https://510kreport.com/methodology