# K231365: Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Intco Medical Products Co., Ltd.
- Decided: Mar 1, 2024 after 295 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: 2 generations back to K082457 (2008). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200671: Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for, Ansell Healthcare Products, LLC (2020) Summary page 6.

## Most influential descendants
- K250630: Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (2025), 0 descendants of its own

## Indications for use
A powder-free 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. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Test Chemotherapy drug & Concentration Average Breakthrough Detection Time (Minutes) Carmustine (BCNU)(3.3 mg/ml) 12.1 min. Cyclophosphamide (Cytoxan) (20.0 mg/ml) >240 min. Doxorubicin Hydrichloride (2.0mg/) >240 min. Etoposide (Toposar) (20.0mg/ml) >240 min. Fluorouracil (50.0mg/ml) >240 min. Methotrexate (25.0 mg/ml) >240 min. Paclitaxel (Taxol) (6.0 mg/ml) >240 min. Thiotepa(10.0 mg/ml) 10.1 min. Vincristine Sulfate(1.0 mg/ml) >240 min. Cisplatin(1.0 mg/ml) >240 min. Dacarbazine(l0 mg/ml) >240 min. Mitomycin C(0.5 mg/ml) >240 min. Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 12.1 minutes and Thiotepa:10.1 minutes. Warning: Do not use with Carmustine or Thiotepa Fentanyl Citrate & Concentration Minimum Breakthrough Detection Times Fentanyl Citrate Injection(l00 mcg/2ml) >240 min.

Source page: https://510kreport.com/device/K231365
Methodology: https://510kreport.com/methodology