# K230847: Chemotherapy Gloves

- Pathway: 510(k) (Traditional)
- Applicant: 3A Glove Sdn. Bhd.
- Decided: Sep 29, 2023 after 185 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: 2 generations back to K182176 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190860: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color, Ever Growth (Vietnam) Co., Ltd. (2019) Summary page 6.

## Indications for use
Chemotherapy Gloves is a disposable device intended for medical purpose that is worn on the examiner’s hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. The proposed device is non-sterile, with fern green, midnight black and sky blue three colors. Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes (minutes) Carboplatin 10 mg/ml(10,000 ppm) > 240 min. Carmustine 3.3 mg/ml (3,300 ppm) Midnight black:32.6(33.2,32.6,33.0) min. Sky blue:24.5(25.2,24.5,26.1) min Fern Green:24.3(28.1,26.3,24.3) min. Cisplatin 1.0 mg/ml(1,000 ppm) > 240 min. Cyclophosphamide 20.0 mg/ml(20,000 ppm) > 240 min. Dacarbazine 10 mg/ml (10,000 ppm) > 240 min. Docetaxel 10 mg/ml (10,000 ppm) > 240 min. Doxorubicin HCL 2.0 mg/ml(2,000 ppm) > 240 min. Epirubicin HCI 2 mg/ml (2,000 ppm) > 240 min. Etoposide 20 mg/ml (20,000 ppm) > 240 min. Fluorouracil 50.0 mg/ml(50,000 ppm) > 240 min. Gemcitabine 38 mg/ml (38,000 ppm) > 240 min. Ifosfamice 50 mg/ml (50,000 ppm) > 240 min. Ifinotecan 20 mg/ml (20,000 ppm) > 240 min. Methotrexate 25 mg/ml (25,000 ppm) > 240 min. Mitomycin 0.5 mg/ml (500 ppm) > 240 min. Mitoxantrone HCI 2 mg/ml (2,000 ppm) > 240 min. Oxaliplatin 5 mg/ml (5,000 ppm) > 240 min. Paclitaxel 6.0 mg/ml(6,000 ppm) > 240 min. Thio Tepa 10.0 mg/ml(10,000 ppm) Midnight black: 58.7(87.2,67.8,58.7) Vincristine Sulfate Please note that the following drugs have low permeation times: 1 mg/ml (1,000 ppm) Sky blue: 77.3(77.3,85.8,79.8) Fern Green: 67.9(68.4,67.9,79.2) > 240 min. Midnight black: Carmustine 3.3 mg/ml 32.6 Minutes (min.); Thio Tepa 10.0 mg/ml 58.7 Minutes (min.). Sky blue: Carmustine 3.3 mg/ml 24.5 Minutes (min.); Thio Tepa 10.0 mg/ml 77.3 Minutes (min.). Fern green: Carmustine 3.3 mg/ml 24.3 Minutes (min.); Thio Tepa 10.0 mg/ml 67.9 Minutes (min.). Warning: Please do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K230847
Methodology: https://510kreport.com/methodology