# K200453: Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs Blue-AC

- Pathway: 510(k) (Traditional)
- Applicant: Yty Industry (Manjung) Sdn Bhd
- Decided: May 1, 2020 after 67 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: Blue Tested Chemotherapy Drug And Concentration Average Breakthrough Detection Time (minutes) Carboplatin, 10 mg/ml > 240 minutes Carmustine, 3.3 mg/ml 11.3 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 7.4 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): 11.3 minutes ThioTEPA (10.0 mg/ml): 7.4 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 and Fentanyl Citrate: Blue Tested Chemotherapy Drug And Concentration Average Breakthrough Detection Time (minutes) Carboplatin, 10 mg/ml > 240 minutes Carmustine, 3.3 mg/ml 30.3 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 91.0 minutes Vincristine Sulfate, 1.0 mg/ml > 240 minutes Busulfan, 6 mg/ml > 240 minutes Cytarabine, 100 mg/ml > 240 minutes Daunorubicin, 5 mg/ml > 240 minutes Docetaxel, 10 mg/ml > 240 minutes Epirubicin, 2 mg/ml > 240 minutes Gemcitabine, 38 mg/ml > 240 minutes Irinotecan Hydrochloride, 20 mg/ml > 240 minutes Mechlorethamine HCL, 1.0 mg/ml > 240 minutes Melphalan, 5 mg/ml > 240 minutes Trisenox, 0.1 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): 30.3 minutes ThioTEPA (10.0 mg/ml): 91.0 minutes CAUTION: CARMUSTINE (3.3 MG/ML) AND THIOTEPA (10 MG/ML) HAVE MUCH LOWER PERMEATION TIMES COMPARE TO OTHER CHEMOTHERAPY DRUGS

Source page: https://510kreport.com/device/K200453
Methodology: https://510kreport.com/methodology