# K213440: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Luliang Hongruida Health Protection Technology Co., Ltd.
- Decided: Feb 18, 2022 after 116 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.
5 later devices descend from it; 2 cite it directly.
0 of 14 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 6.

## Most influential descendants
- K223559: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) (2023), 3 descendants of its own
- K231349: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) (2023), 2 descendants of its own
- K232654: Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) (2024), 0 descendants of its own
- K240072: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate (2024), 0 descendants of its own
- K233970: Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) (2024), 0 descendants of its own

## Indications for use
Powder Free Nitrile Examination Gloves (Blue, Purple-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. The following chemicals have been tested with these gloves: For Blue gloves: Chemotherapy Drug Minimum BDT (Minutes) Bleomycin Sulfate 15mg/ml (15000 ppm) >240 Busulfan 6mg/ml (6,000 ppm) >240 Carboplatin 10mg/ml (10,000 ppm) >240 Carmustine 3.3 mg/ml (3,300 ppm) 25.5 Chloroquine 50mg/ml (50,000ppm) >240 Cisplatin 1mg/ml (1,000 ppm) >240 Cyclophosphamide 20mg/ml (20,000 ppm) >240 Cyclosporin 100 mg/ml (100,000 ppm) >240 Cytarabine HCL, 100 mg/ml (100,000 ppm) >240 Dacarbazine 10 mg/ml (10,000 ppm) >240 Daunorubicin HCL, 5 mg/ml (5,000 ppm) >240 Docetaxel HCL, 10 mg/ml (10,000 ppm) >240 Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240 Epirubicin HCL, 2 mg/ml (2,000 ppm) >240 Etoposide, 20 mg/ml (20,000 ppm) >240 Fludarabine, 25 mg/ml (25,000 ppm) >240 Fluorouracil, 50mg/ml (50,000ppm) >240 Gemcitabine, 38mg/ml (38,000ppm) >240 Idarubicin HCL, Img/ml (1,000ppm) >240 Ifosfamide, 50mg/ml (50,000ppm) >240 Irinotecan, 20mg/ml (20,000ppm) >240 Mechlorethamine HCI, Img/ml (1,000ppm) >240 Melphalan, Smg/ml (5,000ppm) >240 Methotrexate, 25mg/ml (25,000ppm) >240 Mitomycin, 0.5mg/ml (500ppm) >240 Mitoxantrone HCL, 2mg/ml (2,000ppm) >240 Oxaliplatin, Smg/ml (5,000ppm) >240 Paclitaxel, 6mg/ml (6,000ppm) >240 Paraplatin/Carboplatin, 10mg/ml (10,000ppm) >240 Retrovir, 10mg/ml (10,000ppm) >240 Rituximab, 10mg/ml (10,000ppm) >240 Thiotepa, 10mg/ml (10,000ppm) 66.8 Topotecan, 1mg/ml (1,000ppm) >240 Trisenox, 1mg/ml (1,000ppm) >240 Velcade (Bortezomib) , Img/ml (1,000ppm) >240 Vincristine Sulfate, 1mg/ml (1,000ppm) >240 * Please note that the following drugs have extremely low permeation times: Carmustine: 25.5 minutes, Thiotepa: 66.8 minutes For Purple-Blue gloves: Chemotherapy Drug Minimum BDT (Minutes) Bleomycin Sulfate 15mg/ml (15000 ppm) >240 Busulfan 6mg/ml (6,000 ppm) >240 Carboplatin 10mg/ml (10,000 ppm) >240 Carmustine 3.3 mg/ml (3,300 ppm) 21.2 Chloroquine 50mg/ml (50,000ppm) >240 Cisplatin 1mg/ml (1,000 ppm) >240 Cyclophosphamide 20mg/ml (20,000 ppm) >240 Cyclosporin 100 mg/ml (100,000 ppm) >240 Cytarabine HCL, 100 mg/ml (100,000 ppm) >240 Dacarbazine 10 mg/ml (10,000 ppm) >240 Daunorubicin HCL, 5 mg/ml (5,000 ppm) >240 Docetaxel HCL, 10 mg/ml (10,000 ppm) >240 Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240 Epirubicin HCL, 2 mg/ml (2,000 ppm) >240 Etoposide, 20 mg/ml (20,000 ppm) >240 Fludarabine, 25 mg/ml (25,000 ppm) >240 Fluorouracil, 50mg/ml (50,000ppm) >240 Gemcitabine, 38mg/ml (38,000ppm) >240 Idarubicin HCL, Img/ml (1,000ppm) >240 Ifosfamide, 50mg/ml (50,000ppm) >240 Irinotecan, 20mg/ml (20,000ppm) >240 Mechlorethamine HCI, 1mg/ml (1,000ppm) >240 Melphalan, 5Smg/ml (5,000ppm) >240 Methotrexate, 25mg/ml (25,000ppm) >240 Mitomycin, 0.5mg/ml (500ppm) >240 Mitoxantrone HCL, 2mg/ml (2,000ppm) >240 Oxaliplatin, Smg/ml (5,000ppm) >240 Paclitaxel, 6mg/ml (6,000ppm) >240 Paraplatin/Carboplatin, 10mg/ml (10,000ppm) >240 Retrovir, 10mg/ml (10,000ppm) >240 Rituximab, 10mg/ml (10,000ppm) >240 Thiotepa, 10mg/ml (10,000ppm) 36.3 Topotecan, 1mg/ml (1,000ppm) >240 Trisenox, 1mg/ml (1,000ppm) >240 Velcade (Bortezomib) , 1mg/ml (1,000ppm) >240 Vincristine Sulfate, 1mg/ml (1,000ppm) >240 * Please note that the following drugs have extremely low permeation times: Carmustine: 21.2 minutes, Thiotepa: 36.3 minutes

Source page: https://510kreport.com/device/K213440
Methodology: https://510kreport.com/methodology