# K223235: Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)

- Pathway: 510(k) (Abbreviated)
- Applicant: Pt. Sintong Unigolden Glove
- Decided: Oct 26, 2022 after 13 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: 6 generations back to K160562 (2016). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Guangdong Kingfa Sci. & Tech.Co., Ltd. (2022) Summary page 5.

## Indications for use
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a single-use, powder-free, non-sterile device. The tested chemotherapy drugs and their breakthrough detection times are as follows: Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes Carboplatin 10 mg/ml (10,000 ppm) > 240 Minutes Carmustine 3.3 mg/ml (3,300 ppm) 15.9 Minutes Cisplatin 1 mg/ml (1,000 ppm) > 240 Minutes Cyclophosphamide 20 mg/ml (20,000 ppm) > 240 Minutes Cytarabine HCI 100 mg/ml (100,000 ppm) > 240 Minutes Dacarbazine 10 mg/ml (10,000 ppm) > 240 Minutes Docetaxel 10 mg/ml (10,000 ppm) > 240 Minutes Doxorubicin HCI 2 mg/ml (2,000 ppm) > 240 Minutes Etoposide 20 mg/ml (20,000 ppm) > 240 Minutes Fluorouracil 50 mg/ml (50,000 ppm) > 240 Minutes Gemcitabine 38 mg/ml (38,000 ppm) > 240 Minutes Ifosfamide 50 mg/ml (50,000 ppm) > 240 Minutes Irinotecan 20 mg/ml (20,000 ppm) > 240 Minutes Mechlorethamine HCl 1 mg/ml (1,000 ppm) > 240 Minutes Melphalan 5 mg/ml (5,000 ppm) > 240 Minutes Methotrexate 25 mg/ml (25,000 ppm) > 240 Minutes Mitoxantrone 2 mg/ml (2,000 ppm) > 240 Minutes Paclitaxel 6 mg/ml (6,000 ppm) > 240 Minutes Thiotepa 10 mg/ml (10,000 ppm) 54.2 Minutes Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 15.9 Minutes Thiotepa 10 mg/ml 54.2 Minutes Warning: Please do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K223235
Methodology: https://510kreport.com/methodology