# K240072: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Special)
- Applicant: Luliang Hongruida Health Protection Technology Co., Ltd.
- Decided: Feb 9, 2024 after 30 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: 8 generations back to K042805 (2004). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213440: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs, Luliang Hongruida Health Protection Technology Co., Ltd. (2022) Summary page 7.

## Indications for use
The glove is disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner. In addition, gloves were tested for use with Chemotherapy drugs and fentanyl citrate in accordance with ASTM D6978. 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, 1mg/ml (1,000ppm) >240 Ifosfamide, 50mg/ml (50,000ppm) >240 Irinotecan, 20mg/ml (20,000ppm) >240 Mechlorethamine HCI, 1mg/ml (1,000ppm) >240 Melphalan, 5mg/ml (5,000ppm) >240 Methotrexate, 25mg/ml (25,000ppm) >240 Mitomycin, 0.5mg/ml (500ppm) >240 Mitoxantrone HCL, 2mg/ml (2,000ppm) >240 Oxaliplatin, 5mg/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) , 1mg/ml (1,000ppm) >240 Vincristine Sulfate, 1mg/ml (1,000ppm) >240 Fentanyl Citrate Minimum BDT (Minutes) Fentanyl Citrate Injection (100mcg/2mL) >240 * Please note that the following drugs have extremely low permeation times: Carmustine: 25.5 minutes, Thiotepa: 66.8 minutes Warning: Do not use with Carmustine and Thiotepa. 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, 1mg/ml (1,000ppm) >240 Ifosfamide, 50mg/ml (50,000ppm) >240 Irinotecan, 20mg/ml (20,000ppm) >240 Mechlorethamine HCI, 1mg/ml (1,000ppm) >240 Melphalan, 5mg/ml (5,000ppm) >240 Methotrexate, 25mg/ml (25,000ppm) >240 Mitomycin, 0.5mg/ml (500ppm) >240 Mitoxantrone HCL, 2mg/ml (2,000ppm) >240 Oxaliplatin, 5mg/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 Fentanyl Citrate Minimum BDT (Minutes) Fentanyl Citrate Injection (100mcg/2mL) >240 * Please note that the following drugs have extremely low permeation times: Carmustine: 21.2 minutes, Thiotepa: 36.3 minutes Warning: Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K240072
Methodology: https://510kreport.com/methodology