# K260703: Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl

- Pathway: 510(k) (Traditional)
- Applicant: S&S Glove Corporation
- Decided: Jun 3, 2026 after 91 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 K183287 (2019). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232266: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Better Care Plastic Technology Co., Ltd. (2023) Summary page 7.

## Indications for use
Powder Free Blue Nitrile Examination Glove- Tested for Use with Chemotherapy Drugs and Fentanyl: The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05. The following chemicals have been tested with these gloves: Chemotherapy Drugs Concentration mg/ml Breakthrough Detection Time in Minutes 1 Carmustine, 3.3mg/ml (3,300 ppm) 22.7 min 2 Cisplatin, 1mg/ml (1,000 ppm) >240min 3 Cyclophosphamide, 20mg/ml (20,000 ppm) >240min 4 Dacarbazine (DTIC), 10mg/ml (10,000 ppm) >240min 5 Doxorubicin HCI (Adriamycin), 2mg/ml (2,000 ppm) >240min 6 Etoposide (Toposar), 20mg/ml (20,000 ppm) >240min 7 Fluorouracil (5 Flu), 50mg/ml (50,000 ppm) >240min 8 Methotrexate, 25mg/ml (25,000 ppm) >240min 9 Mitomycin C, 0.5 mg/ml (500 ppm) >240min 10 Mitoxantrone HCI, 2mg/ml (2,000 ppm) >240min 11 Paclitaxel (Taxol), 6mg/ml (6,000 ppm) >240min 12 Thio-Tepa, 10mg/ml (10,000 ppm) 11.1 min 13 Vincristine Sulphate, 1mg/ml (1,000 ppm ) >240 min Non-chemotherapy Drugs Concentration mg/ml Breakthrough Detection Time in Minutes 1 Fentanyl Citrate, 100mcg/2ml >240min Testing showed an average breakthrough time of 11.1 minutes with Thio-Tepa, 10mg/ml (10,000 ppm) and 22.7 minutes with Carmustine, 3.3mg/ml (3,300 ppm) Warning: Do not use with Carmustine and Thiotepa Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl: The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05. The following chemicals have been tested with these gloves: Chemotherapy Drugs Concentration mg/ml Breakthrough Detection Time in Minutes 1 Carmustine, 3.3mg/ml (3,300 ppm) 21.4 min 2 Cisplatin, 1mg/ml (1,000 ppm) >240min 3 Cyclophosphamide, 20mg/ml (20,000 ppm) >240min 4 Dacarbazine (DTIC), 10mg/ml (10,000 ppm) >240min 5 Doxorubicin HCI (Adriamycin), 2mg/ml (2,000 ppm) >240min 6 Etoposide (Toposar), 20mg/ml (20,000 ppm) >240min 7 Fluorouracil (5 Flu), 50mg/ml (50,000 ppm) >240min 8 Methotrexate, 25mg/ml (25,000 ppm) >240min 9 Mitomycin C, 0.5 mg/ml (500 ppm) >240min 10 Mitoxantrone HCI, 2mg/ml (2,000 ppm) >240min 11 Paclitaxel (Taxol), 6mg/ml (6,000 ppm) >240min 12 Thio-Tepa, 10mg/ml (10,000 ppm) 15.5 min 13 Vincristine Sulphate, 1mg/ml (1,000 ppm ) >240 min Non-chemotherapy Drugs Concentration mg/ml Breakthrough Detection Time in Minutes 1 Fentanyl Citrate, 100mcg/2ml >240min Testing showed an average breakthrough time of 15.5 minutes with Thio-Tepa, 10mg/ml (10,000 ppm) and 21.4 minutes with Carmustine, 3.3mg/ml (3,300 ppm). Warning: Do not use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K260703
Methodology: https://510kreport.com/methodology