# K133949: Powder Free Nitrile Patient Examination Glove,Blue and Orange Colored,Non-Sterile Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Top Calibre Sdn Bhd
- Decided: Apr 8, 2014 after 106 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
Longest line of descent: 1 generation back to K091652 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091652: Nitrile Powder Fre Examination Gloves (Blue) Tested for Use with Chemothreapy Drugs, Hartalega 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 examiners 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) — 15.1 Cisplatin (1.0 mg/ml) — > 240 Cyclophosphamide (Cytoxan) (20 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) — > 240 Vincristine Sulfate (1.0 mg/ml) — > 240 Please note that the following drug - Carmustine has extremely short permeation times of 15.1 minutes. A patient examination glove is a disposable device intended for medical purposes that is worn on the examinees 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) — 27.9 Cisplatin (1.0 mg/ml) — > 240 Cyclophosphamide (Cytoxan) (20 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) — > 240 Vincristine Sulfate (1.0 mg/ml) — > 240 Please note that the following drug - Carmustine has extremely short permeation times of 17.9 minutes.

Source page: https://510kreport.com/device/K133949
Methodology: https://510kreport.com/methodology