# K193666: Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Aug 4, 2020 after 217 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: 3 generations back to K082957 (2009). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111248: Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue), Yty Industry (Manjung) Sdn Bhd (2011) Summary page 7.

## Most influential descendants
- K243796: GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] (2025), 0 descendants of its own

## 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. Chemo Drugs Tested: Breakthrough Time (Minutes) Aresenic Trioxide 1 mg/ml (1,000 ppm) >240 Azacitidine 25 mg/ml (25,000 ppm) >240 Bendamustine 5 mg/ml (5,000 ppm) >240 Bleomycin 15 mg/ml (15,000 ppm) >240 Bortezomib 1 mg/ml (1,000 ppm) >240 Busulfan 6 mg/ml (6,000 ppm) >240 Carboplatin 10.0 mg/ml (10,000 ppm) >240 Carfilzomib 2.0 mg/ml (2,000) >240 Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 33.1 min Cetuximab 2.0 mg/ml (2,000) >240 Cisplatin 1.0 mg/ml (1,000 ppm) >240 Cyclophosphamide (Cytoxan) 20.0 mg/ml (20,000 ppm) >240 Cytarabine 100 mg/ml (100,000 ppm) >240 Cytovene 10 mg/ml (10,000 ppm) >240 Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) >240 Daunorubicin 5 mg/ml (5,000 ppm) >240 Decitabine 5 mg/ml (5,000 ppm) >240 Docetaxel 10.0 mg/ml (10,000 ppm) >240 Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) >240 Epirubicin (Ellence) 2.0 mg/ml (2,000 ppm) >240 Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) >240 Fludarabine 25 mg/ml (25,000 ppm) >240 Fluorouracil 50.0 mg/ml (50,000 ppm) >240 Fulvestrant 50.0 mg/ml (50,000 ppm) >240 Gemcitabine (Gemzar) 38 mg/ml (38,000 ppm) >240 Idarubicin 1 mg/ml (1,000 ppm) >240 lfosfamide 50.0 mg/ml (50,000 ppm) >240 Irinotecan 20.0 mg/ml (20,000 ppm) >240 Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) >240 Melphalan 5 mg/ml (5,000 ppm) >240 Methotrexate 25 mg/ml (25,000 ppm) >240 Mitomycin C 0.5 mg/ml (500 ppm) >240 Mitoxantrone 2.0 mg/ml (2,000 ppm) >240 Oxaliplatin 2.0 mg/ml (2,000 ppm) >240 Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) >240 Paraplatin 10 mg/ml (10,000 ppm) >240 Pemetrexed Disodium 25.0 mg/ml (25,000 ppm) >240 Pertuzumab 30 mg/ml (30,000 ppm) >240 Raltitrexed 0.5 mg/ml (500 ppm) >240 Retrovir 10.0 mg/ml (10,000 ppm) >240 Rituximab 10 mg (10,000 ppm) >240 Temsirolimus 25.0 mg/ml (25,000 ppm) >240 Thiotepa 10.0 mg/ml (10,000 ppm) 69.2 min Topotecan HCI 1.0 mg/ml (1,000 ppm) >240 Trastuzumab 21.0 mg/ml (21,000 ppm) >240 Trisonex 1 mg/ml (1,000 ppm) >240 Vinblastine 1 mg/ml (1,000 ppm) >240 Vincristine Sulfate 1.0 mg/ml (1,000 ppm) >240 Vinorelbine 10 mg/ml (10,000 ppm) >240 Zoledronic Acid 0.8 mg/ml (800 ppm) >240 Fentanyl Citrate, 100mcg/2mL >240min 62.0 Please note that the following drug has low permeation time: Carmustine (BCNU) (3.3 mg/ml) 33.1 minutes Thiotepa (THT) (10.0mg/ml) 69.2 minutes CAUTION: Testing showed an average breakthrough time of33.l minutes with Carmustine and 69.2 minutes with Thiotepa 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. Chemotherapy Drug Tested Breakthrough Time (in minutes) Aresenic Trioxide 1 mg/ml >240 Azacitidine 25 mg/ml >240 Bendamustine 5 mg/ml >240 Bleomycin 15 mg/m >240 Bortezomib 1 mg/ml >240 Busulfan 6 mg/ml >240 Carfilzomib 2 mg/ml >240 Carmustine (BCNU) 3.3 mg/ml 59.4 min Cetuximab >240 Cisplatin 1.0 mg/ml >240 Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 Cytarabine Hydrochloride 100 mg/ml >240 Cytovene 10 mg/ml >240 Dacarbazine (DTIC) 10.0 mg/ml >240 Daunorubicin 5 mg/ml >240 Decitabine 5 mg/ml >240 Docetaxel 10.0 mg/ml >240 Doxorubicin Hydrochloride 2.0 mg/ml >240 Epirubicin (Ellence) 2.0 mg/ml >240 Etoposide (Toposar) 20.0 mg/ml >240 Fludarabine 25 mg/ml >240 Fluorouracil 50.0 mg/ml >240 Fulvestrant 50.0 mg/ml >240 Gemcitabine (Gemzar) 38 mg/ml >240 Idarubicin 1 mg/ml >240 Ifosfamide 50.0 mg/ml >240 Irinotecan 20.0 mg/ml >240 Mechlorethamine HCI 1.0 mg/ml >240 Melphalan 5 mg/ml >240 Methotrexate 25.0 mg/ml >240 Mitomycin C 0.5 mg/ml >240 Mitoxantrone 2mg/ml >240 Oxaliplatin 5.0 mg/ml >240 Paclitaxel (Taxol) 6.0 mg/ml >240 Paraplatin (Carboplatin) 10 mg/ml >240 Pemetrexed Disodium 25.0 mg/ml >240 Pertuzumab 30 mg/ml >240 Raltitrexed 0.5 mg/ml >240 Retrovir 10.0 mg/ml >240 Rituximab 10 mg/ml >240 Temsirolimus 25.0 mg/ml >240 Thiotepa 10.0 mg/ml 68.2 min Topotecan HCI 1.0 mg/ml >240 Trastuzumab 21.0 mg/ml >240 Trisonex 1 mg/ml >240 Vinblastine 1 mg/ml >240 Vincristine Sulfate 1.0 mg/ml >240 Vinorelbine 10 mg/ml >240 Zoledronic Acid 0.8 mg/ml >240 Fentanyl Citrate, 100mcg/2mL >240 167.8 min Please note that the following drug has low permeation time: Carmustine (BCNU) (3 .3 mg/ml) 59 .4 minutes Thiotepa (THT) (10.0 mg/ml) 68.2 minutes CAUTION: Testing showed an average breakthrough time of 59.4 minutes with Carmustine and 68.2 minutes with Thiotepa

Source page: https://510kreport.com/device/K193666
Methodology: https://510kreport.com/methodology