# K160562: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega Snd. Bhd.
- Decided: Oct 13, 2016 after 227 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K162982: Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) (2017), 8 descendants of its own
- K180696: Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs) (2018), 7 descendants of its own
- K192315: Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) (2020), 6 descendants of its own
- K211220: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs (2021), 5 descendants of its own
- 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 (2022), 3 descendants of its own

## Indications for use
A non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs in accordance with ASTM D6978-05, Standard Practice for Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) is as below: Carmustine (3.3 mg/ml) 10.1 minutes Cisplatin (1.0 mg/ml) >240 minutes Cyclophosphamide (20 mg/ml) >240 minutes Dacarbazine (10.1 mg/ml) >240 minutes Doxorubicin Hydrochloride (2.0 mg/ml) >240 minutes Etoposide (20.0 mg/ml) >240 minutes Fluorouracil (50.0 mg/ml) >240 minutes Methotrexate (25 mg/ml) >240 minutes Mitomycin C (0.5 mg/ml) >240 minutes Paclitaxel (6.0 mg/ml) >240 minutes Thiotepa (10.0 mg/ml) 30.4 minutes Vincristine Sulfate (1.0 mg/ml) >240 minutes

Source page: https://510kreport.com/device/K160562
Methodology: https://510kreport.com/methodology