# K170136: Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Feiyang Professional Gloves Co., Ltd.
- Decided: Aug 25, 2017 after 220 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
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. In addition, these gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug and Concentration — Minimum Breakthrough Detection Time (Minutes) 1. Carmustine (BCNU)(3.3 mg/ml) — 9.1 2. Cisplastin, (1.0 mg/ml) — >240 3. Cyclophosphamide (20 mg/ml) — >240 4. Dacarbazine (DTIC) (10.0mg/ml) — >240 5. Doxorubicin HCL (2.0mg/ml) — >240 6. Etoposide (Toposar) (20 mg/ml) — >240 7. Fluorouracil (50mg/ml) — >240 8. Methotrexate (25 mg/ml) — >240 9. Mitomycin C (0.5 mg/ml) — >240 10. Paclitaxel (Taxol) (6.0 mg/ml) — >240 11. Thiotepa (10 mg/ml) — 36.3 12. Vincristine Sulfate (1 mg/ml) — >240 Please note the following drugs, Carmustine and Thiotepa, have extremely low permeation times of 9.1 and 36.3 minutes respectively

Source page: https://510kreport.com/device/K170136
Methodology: https://510kreport.com/methodology