# K212408: Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Maja Agung Latexindo
- Decided: May 18, 2022 after 288 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 K042805 (2004). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171339: EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs, Eco Medi Glove Sdn. Bhd. (2017) Summary page 5.

## Most influential descendants
- K251716: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (2025), 0 descendants of its own

## Indications for use
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner’s hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate. Chemotherapy Drug and Permeation The following chemicals have been tested with these gloves: Chemotherapy Drug and Concentration Breakthrough Detection Time in Minutes Carboplatin (Paraplatin), 10 mg/ml (10,000ppm) > 240 min. Carmustine (BCNU), 3.3 mg/ml (3,300ppm) 58.3 min (Not recommended for use) Cisplatin, 1.0 mg/ml (1,000ppm) > 240 min Cyclophosphamide (Cytoxan), 20.0mg/ml (20,000 ppm) > 240 min Dacarbazine, 10.0mg/ml (10,000ppm) > 240 min Docetaxel, 10mg/ml (10,000ppm) > 240 min Doxorubicin HCI, 2.0mg/ml (2,000ppm) > 240 min Etoposide, 20.0mg/ml (20,000ppm) > 240 min Fluorouracil, 50.0mg/ml (50,000ppm) > 240 min Ifosfamide, 50 mg/ml (50,000 ppm) > 240 min Methotrexate, 25mg/ml (25,000 ppm) > 240 min Mitomycin C, 0.5 mg/ml (500 ppm) > 240 min Paclitaxel, 6.0 mg/ml (6,000 ppm) > 240 min ThioTepa, 10.0mg/ml (10,000ppm) 119 min (Not recommended for use) Vincristine Sulfate, 1 mg/ml (1,000 ppm) > 240 min Simulated Gastric Acid > 240 min Fentanyl Citrate Injection 100.0 mg/2ml > 240 min WARNING: Do not use with Carmustine (BCNU) 3.3 mg/ml and Thiotepa (10mg/ml).

Source page: https://510kreport.com/device/K212408
Methodology: https://510kreport.com/methodology