# K193121: GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims

- Pathway: 510(k) (Traditional)
- Applicant: Eco Medi Glove Sdn. Bhd.
- Decided: Mar 20, 2020 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: 4 generations back to K022765 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152542: Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs, Riverstone Resources Sdn Bhd (2015) Summary page 5.

## Indications for use
The Gen 2 Nitrile Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by Chemotherapy Drugs. Chemotherapy Drugs and Concentration Minimum Breakthrough detection time in minutes(jtg/cm®minute) DCarmustine (BCNU)(3.3 mg/ml)(3,300ppm) 22 2)Cisplatin (1.0 mg/mI)(1,000ppm) No breakthrough up to 240 min 3)Cyclophosphamide (Cytoxan)(20 mg/m1)(20,000ppm) No breakthrough up to 240 min 4)Methotexale (25mg/ml)(25,000ppm) No breakthrough up to 240 min 5)Doxorubicin Hydrochloride (2.0 mg/m1)(2,000ppm) No breakthrough up 1o 240 min 6)Etoposide (Toposar)}(20.0 mg/ml)(20,000ppm) No breakthrough up to 240 min TFluorouracit (50.0 mg/ml)(50,000ppm) No breakthrough up to 240 min 8)Paclitaxel (Taxol}(6.0 mg/mi}(6,000ppm) No breakthrough up to 240 min 9YThiotepa (10.0 mg/m!)(10,000ppm) . 474 The Maximum testing time is 240 minutes. Please note that the following drugs have low permeation time: [)Carmustine (BCNU)(3.3mg/ml)with Permeation time of 22 minutes. 2)Thiotepa ( 10.0mg/ml)with Permeation time of 47.4 minutes.

Source page: https://510kreport.com/device/K193121
Methodology: https://510kreport.com/methodology