# K250502: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)

- Pathway: 510(k) (Special)
- Applicant: Safesource Direct, LLC
- Decided: Mar 19, 2025 after 27 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: 7 generations back to K042805 (2004). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222898: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves, Safesource Direct, LLC (2022) Summary page 6.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Cisplatin 1.0 mg/ml > 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240 Minutes Dacarbazine (DTIC) 10.0 mg/ml > 240 Minutes Doxorubicin Hydrochloride 2.0 mg/ml > 240 Minutes Etoposide (Toposar) 20.0 mg/ml > 240 Minutes Fluorouracil 50.0 mg/ml 0.5 mg/ml > 240 Minutes Methotrexate 25 mg/ml > 240 Minutes Mitomycin C 0.5 mg/ml > 240 Minutes Paclitaxel (Taxol) 6.0 mg/ml > 240 Minutes Thio-Tepa 10.0 mg/ml 87.0 Minutes Vincristine Sulfate (Oncovin) 1.0 mg/ml > 240 Minutes Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Thio-Tepa 10.0 mg/ml 87.0 Minutes Warning: Not recommended for use with these drugs. A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Carmustine (BCNU) 3.3 mg/ml 22.5 Minutes Cisplatin 1.0 mg/ml > 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240 Minutes Dacarbazine (DTIC) 10.0 mg/ml > 240 Minutes Doxorubicin Hydrochloride 2.0 mg/ml > 240 Minutes Etoposide (Toposar) 20.0 mg/ml > 240 Minutes Fluorouracil 50.0 mg/ml 0.5 mg/ml > 240 Minutes Methotrexate 25 mg/ml > 240 Minutes Mitomycin C 0.5 mg/ml > 240 Minutes Paclitaxel (Taxol) 6.0 mg/ml > 240 Minutes Thio-Tepa 10.0 mg/ml 37.5 Minutes Vincristine Sulfate (Oncovin) 1.0 mg/ml > 240 Minutes Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 22.5 Minutes Thio-Tepa 10.0 mg/ml 37.5 Minutes Warning: Not recommended for use with these drugs.

Source page: https://510kreport.com/device/K250502
Methodology: https://510kreport.com/methodology