# K220545: Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Hl Rubber Industries Sdn Bhd
- Decided: May 26, 2022 after 90 days
- Product code: LZC (Medical Glove, Specialty)
- 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 powder-free patient examination glove is a disposable device intended for medical purposes 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 D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: No. Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time (Minutes) Carmustine (BCNU) (3.3 mg/ml) 23.4 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (Cytoxan) (20.0 mg/mI) >240 Dacarbazine (DTIC) (10.0 mg/ml) >240 Doxorubicin Hydrochloride (2.0 mg/ml) >240 Etoposide (Toposar) (20.0 mg/ml) >240 Fluorouracil (50.0 mg/ml) >240 Ifosfamide (50.0 mg/ml) >240 Mitoxantrone (2.0 mg/ml) >240 Paclitaxel (Taxol) (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 77.5 Vincristine Sulfate (1.0 mg/ml) >240 Fentanyl Citrate Injection 100.0 mcg/ 2ml >240 Please note that the following drugs have extremely low permeation time: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 23.4 minute and Thiotepa (10.0 mg/mI) has a minimum breakthrough time of 77.5 minute. Warning statements has been included. WARNING: DO NOT USE WITH CARMUSTINE WARNING: DO NOT USE WITH THIOTEPA

Source page: https://510kreport.com/device/K220545
Methodology: https://510kreport.com/methodology