# K161944: Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Baisheng Medical Products Co., Ltd.
- Decided: Nov 21, 2016 after 129 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 K022765 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141623: Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling Claim, Eco Medi Glove Sdn. Bhd. (2014) Summary page 5.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Minimum Breakthrough Detection Concentration Time ( Minutes ) I, Carmustine (BCNU) (3.3 mg/ml) 13.6 2. Cisplastin, (1.0 mg/ml) >240 3. Cyclophosphamide (20 mg/ml) >240 4, Doxorubicin HCI (2.0 mg/ml) >240 5. Etoposide (Toposar) (20 mg/ml) >240 6. Fluorouracil (50 mg/ml) >240 7. Methotrexate (25 mg/ml) >240 8. Mitomycein C (0.5 mg/ml) >240 9. Paclitaxel (Taxol) (6.0 mg/ml) >240 10. Thiotepa (10 mg/ml) 26.9 11, Vincristine Sulfate (1 mg/ml) . >24() Please note the following drugs, Carmustine and Thiotepa, have extremely low permeation times of 13.6 and 26.9 minutes, respectively.

Source page: https://510kreport.com/device/K161944
Methodology: https://510kreport.com/methodology