# K183280: PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs

- Pathway: 510(k) (Traditional)
- Applicant: Smart Glove Corporation Sdn. Bhd.
- Decided: Jul 26, 2019 after 245 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 purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below. Chemotherapy Drug permeation and concentration ( Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves. Breakthrough Detection Time in Minutes Chemotherapy Drugs: White Glove Blue Glove 1. Carmustine ( BCNU)3.3 mg/ml(3,300 ppm) 7.1 min 23.4 min 2. Cisplatin 1.0 mg/ml (l ,000ppm) >240 min >240 min 3. Cyclophosphamide (Cytoxan) 20mg/ml(20,000ppm) >240 min >240 min 4. Dacarbazine (DTIC)l0.0 mg/ml(I0,000ppm) >240 min >240 min 5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) >240 min >240 min 6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) >240 min >240 min 7. Fluorouracil 50.0 mg/ml (50,000ppm) >240 min >240 min 8. lfosfamide 50.0 mg/ml (50,000ppm) >240 min >240 min 9. Methotrexate 25 mg/ml (25,000ppm) >240 min >240 min 10.Mitomycin C 0.5 mg/ml (500ppm) >240 min >240 min 11. Mitoxantrone 2.0 mg/ml (2,000ppm) >240 min >240 min 12. Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) >240 min >240 min 13. Thio-Tepa 10.0 mg/ml (10,000ppm) 78.6 min 39.3 min 14.Yincristine Sulfate 1.0 mg/ml ( l ,000ppm) >240 min >240 min WARNING: Do not use with Carmustine or Thio-Tepa. Please note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes.

Source page: https://510kreport.com/device/K183280
Methodology: https://510kreport.com/methodology