# K211810: Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Shamrock Manufacturing Corpora
- Decided: May 23, 2022 after 346 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 5.

## Most influential descendants
- K232064: Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) (2023), 0 descendants of its own

## Indications for use
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner’s hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl. Chemotherapy Drug and Permeation The following chemicals have been tested with these gloves: Chemotherapy Drug and Concentration Breakthrough Detection Time in Minutes Carboplatin (Paraplatin), 10 mg/ml (10,000ppm) > 240 min. Carmustine (BCNU), 3.3 mg/ml (3,300ppm) 46.6 min. Chloroquine 50mg/ml (50,000ppm) > 240 min Cisplatin, 1.0 mg/ml (1,000ppm) > 240 min Cyclophosphamide (Cytoxan), 20.0mg/ml (20,000 ppm) > 240 min Dacarbazine, 10.0mg/ml (10,000ppm) > 240 min Docetaxel, 10mg/ml (10,000ppm) > 240 min Doxorubicin HCI, 2.0mg/ml (2,000ppm) > 240 min Etoposide, 20.0mg/ml (20,000ppm) > 240 min Fluorouracil, 50.0mg/ml (50,000ppm) > 240 min Ifosfamide, 50 mg/ml (50,000 ppm) > 240 min Methotrexate, 25mg/ml (25,000 ppm) > 240 min Mitomycin C, 0.5 mg/ml (500 ppm) > 240 min Paclitaxel, 6.0 mg/ml (6,000 ppm) > 240 min Thiotepa, 10.0mg/ml (10,000ppm) 64.8 min Vincristine Sulfate, 1 mg/ml (1,000 ppm) > 240 min Fentanyl Citrate Injection 100mcg/2ml (50mcg/1ml) > 240 min Please note that the following drugs that have low permeation time are: Carmustine (BCNU), 3.3 mg/ml 46.6 min Thiotepa, 10.0mg/ml 64.8 min CAUTION: Testing showed an average of breakthrough time of 46.6 min for Carmustine and 64.8 min for Thiotepa.

Source page: https://510kreport.com/device/K211810
Methodology: https://510kreport.com/methodology