# K202536: Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Yty Industry (Manjung) Sdn Bhd
- Decided: Aug 11, 2021 after 344 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: Aloe Vera Tested Chemotherapy Drug And Concentration Average Breakthrough Detection Time (minutes) Carboplatin, 10 mg/ml > 240 minutes Carmustine, 3.3 mg/ml 11.0 minutes Cisplatin (BCNU), 1.0 mg/ml > 240 minutes Cyclophosphamide (Cytoxan), 20.0 mg/ml > 240 minutes Dacarbazine (DTIC), 10.0 mg/ml > 240 minutes Doxorubicin Hydrochloride, 2.0 mg/ml > 240 minutes Etoposide (Toposar), 20.0 mg/ml > 240 minutes Fluorouracil, 50.0 mg/ml > 240 minutes Ifosfamide, 50.0 mg/ml > 240 minutes Methotrexate, 25 mg/ml > 240 minutes Mitomycin C, 0.5 mg/ml > 240 minutes Mitoxantrone, 2 mg/ml > 240 minutes Paclitaxel (Taxol), 6.0 mg/ml > 240 minutes ThioTEPA, 10.0 mg/ml 59.0 minutes Vincristine Sulfate, 1.0 mg/ml > 240 minutes The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 11.0 minutes ThioTEPA (10.0 mg/ml): 59.0 minutes WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: Fentanyl Tested Chemotherapy Drug And Concentration Average Breakthrough Detection Time (minutes) Carboplatin, 10 mg/ml > 240 minutes Carmustine, 3.3 mg/ml 15.0 minutes Cisplatin (BCNU), 1.0 mg/ml > 240 minutes Cyclophosphamide (Cytoxan), 20.0 mg/ml > 240 minutes Dacarbazine (DTIC), 10.0 mg/ml > 240 minutes Doxorubicin Hydrochloride, 2.0 mg/ml > 240 minutes Etoposide (Toposar), 20.0 mg/ml > 240 minutes Fluorouracil, 50.0 mg/ml > 240 minutes Ifosfamide, 50.0 mg/ml > 240 minutes Methotrexate, 25 mg/ml > 240 minutes Mitomycin C, 0.5 mg/ml > 240 minutes Mitoxantrone, 2 mg/ml > 240 minutes Paclitaxel (Taxol), 6.0 mg/ml > 240 minutes ThioTEPA, 10.0 mg/ml 30.1 minutes Vincristine Sulfate, 1.0 mg/ml > 240 minutes Fentanyl Citrate, 100mcg/2ml > 240 minutes The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 15.0 minutes ThioTEPA (10.0 mg/ml): 30.1 minutes WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA

Source page: https://510kreport.com/device/K202536
Methodology: https://510kreport.com/methodology