# K250944: Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl

- Pathway: 510(k) (Special)
- Applicant: Gmp Medicare Sdn. Bhd.
- Decided: Apr 23, 2025 after 26 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
An 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. These gloves were tested for use with chemotherapy drugs with Gastric Acid, Xylazine and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. No Chemotherapy Drugs Concentration (mg/ml) Minimum Breakthrough Detection Time (Min.) 1 Amethopterin 25.0 >240 2 Azacitidine (Vidaza) 25.0 >240 3 Bendamustine HCI 5.0 >240 4 Bleomycin Sulfate 15.0 >240 5 Busulfan 6.0 >240 6 Capecitabine 26.0 >240 7 Carboplatin 10.0 >240 8 Carfilzomib 2.0 >240 9 Carmustine 33 11.0 10 Cetuximab (Erbitux) 2.0 >240 11 Chlroquine 50.0 >240 12 Cisplatin 1.0 >240 13 Cladribine 1.0 >240 14 Cyclophosphamide 20.0 >240 15 Cyclosporin A 100.0 >240 16 Cytarabine 100.0 >240 17 Cytovene 10.0 >240 18 Dacarbazine 10.0 >240 19 Dactinomycin 0.5 >240 20 Daunorubin HCI 5.0 >240 21 Decitabine 5.0 >240 22 Docetaxel 10.0 >240 23 Doxorubicin Hydrochloride 2.0 >240 24 Ellence 2.0 >240 25 Eribulin Mesylate 0.5 >240 26 Etoposide 20.0 >240 27 Fludarabine 25.0 >240 28 Fluorouracil 50.0 >240 29 Fulvestrant 50.0 >240 30 Gemcitabine 38.0 >240 31 Idarubicin 1.0 >240 32 lfostamide 00.0 >240 33 Irinotecan 20.0 >240 34 Ixabepilone 2.0 >240 35 Leuprolide Acetate 5.0 >240 36 Mechlorethamine 1.0 >240 37 Melphalan 5.0 >240 38 MESNA 100.0 >240 39 Methotrexate 25.0 >240 40 Mitomycin C 0.5 >240 41 Mitoxantrone 2.0 >240 42 Oxaliplatin 5.0 >240 43 Paclitaxel 6.0 >240 44 Pemetrexed 250 >240 45 Pertuzumab 30.0 >240 46 Propofol 10.0 >240 47 Raltitrexed 0.5 >240 48 Retrovir 10.0 >240 49 Rituximab 10.0 >240 50 Temsirolimus 25.0 >240 51 Thiotepa 10.0 39.0 52 Topotecan 1.0 >240 53 Trastuzumab 21.0 >240 54 Triclosan 1.0 >240 55 Trisenox 1.0 >240 56 Velcade (Bortezomib) 1.0 >240 57 Vincristine Sulfate 1.0 >240 58 Vinblastine Sulfate 1.0 >240 59 Vinorelbine 10.0 >240 60 Zoledronic Acid 0.8 >240 Please note that Carmustine and Thiotepa have extremely low permeation times of 11 minutes and 39 minutes respectively. Warning: Do not use with Carmustine and Thiotepa no breakthrough detected up to 240 minutes. to have no breakthrough detected up to 240 minutes. found to have no breakthrough detected up to 240 minutes. Gastric Acid - Under the testing conditions of ASTM D6978-05, Simulated Gastric Acid was found to have Xylazine - Under the testing conditions of ASTM D6978-05, Xylazine HCI Injection (100 mg/ml) was found Fentanyl - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2ml) was

Source page: https://510kreport.com/device/K250944
Methodology: https://510kreport.com/methodology