# K123819: Multiple Name

- Pathway: 510(k) (Traditional)
- Applicant: Top Calibre Sdn Bhd
- Decided: Mar 5, 2013 after 83 days
- Product code: LYY (Latex 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: 2 generations back to K972615 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083409: Powder Free Blue Latex Patient Examination Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label, Wrp Asia Pacific Sdn. Bhd. (2009) Summary page 1.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below. Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes) Carmustine (BCNU) (3.3 mg/ml) 15.4 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (Cytoxan) (20.0 mg/ml) >240 Cytarabine (100 mg/ml) >240 Dacarbazine (DTIC) (10.0 mg/ml) >240 Doxorubicin Hydrochloride (2.0 mg/ml) >240 Etoposide (20.0 mg/ml) >240 Fluorouracil (50.0 mg/ml) >240 Ifosfamide (50.0 mg/ml) >240 Methotrexate (25 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Mitoxantrone (2.0 mg/ml) >240 Paclitaxel (Taxol) (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 30.6 Vincristine Sulfate (1.0 mg/ml) >240 Please note that the following drugs - Carmustine and Thiotepa have extremely short permeation times of 15.4 and 30.6 minutes, respectively.

Source page: https://510kreport.com/device/K123819
Methodology: https://510kreport.com/methodology