# K213040: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs,  Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs

- Pathway: 510(k) (Special)
- Applicant: Guangdong Kingfa Sci. & Tech.Co., Ltd.
- Decided: Apr 27, 2022 after 217 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: 5 generations back to K160562 (2016). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211220: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Guangdong Kingfa Sci. & Tech.Co., Ltd. (2021) Summary page 7.

## Most influential descendants
- K261793: Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) (2026), 0 descendants of its own
- K223235: Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) (2022), 0 descendants of its own
- K222714: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs (2022), 0 descendants of its own

## Indications for use
The blue colored nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. The Nitrile Patient Examination Gloves Blue Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows: • Bleomycin Sulfate 15 mg/ml >240 min. • Carboplatin 10 mg/ml >240 min. • Carmustine (BCNU) 3.3 mg/ml 17.2 min. • Cisplatin 1.0 mg/ml >240 min. • Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. • Cytarabine HCI 100 mg/ml >240 min. • Dacarbazine (DTIC)lO.0 mg/ml >240 min. • Daunorubicin 5.0 mg/ml >240 min. • Docetaxel 10.0 mg/ml >240 min • Doxorubicin HCI 2.0 mg/ml >240 min. • Etoposide (Toposar) 20.0 mg/ml >240 min. • Fluorouracil 50.0 mg/ml >240 min. • Gemcitabine 38 mg/ml>240 min. • Idarubicin 1 mg/ml >240 min. • lfosfamide 50.0 mg/ml >240 min. • Irinotecan 20.0 mg/ml >240 min. • Mechlorethamine HCI 1.0 mg/ml>240 min. • Melphalan 5 mg/ml >240 min. • Methotrexate 25 mg/ml >240 min. • Mitromycin C. 0.5 mg/ml >240 • Mitoxantrone 2.0 mg/ml >240 min. • Paclitaxel (Taxol) 6.0 mg/ml >240 min. • Thiotepa 10.0 mg/ml 13.9 min. • Vincristine Sulfate 1.0 mg/ml >240 min. Warning: Do not use with Carmustine and Thiotepa. The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. The Nitrile Patient Examination Gloves Blue Violet Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows: • Carmustine (BCNU) 3.3 mg/ml 65.3 min. • Cisplatin 1.0 mg/ml >240 min. • Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. • Dacarbazine (DTIC)lO.0 mg/ml >240 min. • Doxorubicin HCI 2.0 mg/ml >240 min. • Etoposide (Toposar) 20.0 mg/ml >240 min. • Fluorouracil 50.0 mg/ml >240 min. • Methotrexate 25 mg/ml >240 min. • Paclitaxel (Taxol) 6.0 mg/ml >240 min. • Thiotepa 10.0 mg/ml 58.3 min. Waming: Do not use with Carmustine and Thiotepa. The nitrile examination glove is intended to be worn on the hands of examiner’s to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. The Nitrile Patient Examination Gloves Black Colored were tested for use with Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. * Fentanyl Citrate 100mcg/2ml >240 minutes

Source page: https://510kreport.com/device/K213040
Methodology: https://510kreport.com/methodology