# K202083: Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei USA, Inc.
- Decided: Mar 25, 2021 after 241 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 patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Permeation The following chemicals have been tested with these gloves: Chemotherapy Drug and Concentration Breakthrough Detection Time in Minutes Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 23.7 Cisplatin 1.0 mg/ml (1,000ppm) No Breakthrough up to 240 mins. Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) No Breakthrough up to 240 mins. Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) No Breakthrough up to 240 mins. Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) No Breakthrough up to 240 mins. Etoposide(Toposar) 20.0 mg/ml (20,000 ppm) No Breakthrough up to 240 mins. Fluorouracil 50.0 mg/ml (50,000 ppm) No Breakthrough up to 240 mins. Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) No Breakthrough up to 240 mins. Thiotepa 10.0 mg/ml (10,000 ppm) 39.1 CAUTION: Testing showed an average breakthrough time of 39.1 minutes for Thiotepa. WARNING: Do not use with Carmustine.

Source page: https://510kreport.com/device/K202083
Methodology: https://510kreport.com/methodology