# K210730: Nitrile Patient Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: American Performance Polymers, LLC
- Decided: Aug 10, 2021 after 152 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 K183287 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192954: Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Comfort Rubber Gloves Industries Sdn. Bhd. (2020) Summary page 5.

## 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 or finger to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Test Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time (Min.) Carmustine (BCNU), 3 .3 mg/ml 33.3 Cisplatin, 1. 0 mg/ml >240 Cyclophosphamide (Cytoxan). 20.0 mg/ml >240 Cytarabine Hydrochloride, 100 mg/ml >240 Dacarbazine (DTIC), 10.0 mg/ml >240 Daunorubicin, 5 mg/ml >240 Doxorubicin Hydrochloride, 2.0 mg/ml >240 Etoposide (Toposar), 20.0 mg/ml >240 Fluorouracil, 50.0 mg/ml >240 lfosfamide, 50.0 mg/ml >240 Methotrexate, 25.0 mg/ml >240 Mitomycin C, 0.5 mg/ml >240 Mitoxantrone, 2mg/ml >240 Paclitaxel (Taxol), 6.0 mg/ml >240 Thiotepa, 10.0 mg/ml 66.2 Vincristine Sulfate, 1.0 mg/ml >240 Fentanyl Citrate, 100mcg/2mL >240 Please note the following drugs have low permeation times: Carmustine (BCNU) (3.3mg/ml) 33.3 minutes Thiotepa (10.0mg/ml) 66.2 minutes Warning: Do not use these gloves with Carmustine or Thiotepa

Source page: https://510kreport.com/device/K210730
Methodology: https://510kreport.com/methodology