# K183149: Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim

- Pathway: 510(k) (Traditional)
- Applicant: Central Medicare Sdn Bhd
- Decided: Jul 4, 2019 after 233 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
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Low Dermatitis Potential - this product demonstrated reduced potential for sensitizing users to chemical additives. Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results. Chemotherapy Drug Permeation The following chemicals have been tested with these gloves: Tested Chemotherapy Drug Concentrate(mg/ml) Minimum Breakthrough Detection Time (minutes) Bleomycin Sulfate 15 >240 Busulfan 6 >240 Carboplatin 10 >240 *Carmustine 3.3 12.4 Cisplatin 1 >240 Chloroquine 50 >240 Cyclophosphamide 20 >240 Cyclosporin 100 >240 Cytarabine HCI 100 >240 Dacarbazine 10 >240 Daunorubicin HCI 5 >240 Docetaxel 10 >240 Doxorubicin Hydrochloride 2 >240 Epirubicin (Ellence) 2 >240 Etoposide 20 >240 Fludarabine 25 >240 Fluorouracil 50 >240 Gemcitabine 38 >240 Idarubicin 1 >240 Ifosfamide 50 >240 Irinotecan 20 >240 Mechlorethamine HCI 1 >240 Melphalan 5 >240 Methotrexate 25 >240 Mitomycin 0.5 >240 Mitoxantrone 2 >240 Oxaliplatin 5 >240 Paclitaxel 6 >240 Paraplatin 10 >240 Retrovir 10 >240 Rituximab 10 >240 *Thiotepa 10 24.4 Topotecane 1 >240 Trisonex 1 >240 Velcade 1 >240 Vincristine Sulfate 1 >240 * Please note that the following drugs have extremely low permeation times: Carmustine: 12.4 minutes and Thiotepa: 24.4 minutes Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.

Source page: https://510kreport.com/device/K183149
Methodology: https://510kreport.com/methodology