# K252549: Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid

- Pathway: 510(k) (Traditional)
- Applicant: Kossan International Sdn Bhd
- Decided: Jan 13, 2026 after 153 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 is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, Xylazine HCI, and Simulated Gastric Acid as per ASTM D6978-05 (Reapproved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drugs Permeation Test Minimum Breakthrough Detection Time in Minutes Chemotherapy Drugs (Concentration) White-Green Carmustine (BCNU) (3.3 mg/ml) 30.0 (40.0, 30.0, 30.0) Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (Cytoxan) (20.0 mg/ml) >240 Cytarabine HCI (100 mg/ml) >240 Dacarbazine (DTIC) (10.0 mg/ml) >240 Doxorubicin Hydrochloride (2.0 mg/ml) >240 Etoposide (20.0 mg/ml) >240 Fluorouracil (50.0 mg/ml) >240 Ifosfamide (50.0 mg/ml) >240 Methotrexate (25.0 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Mitoxantrone (2.0 mg/ml) >240 Paclitaxel (Taxol) (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 60.0 (100.0, 80.0, 60.0) Vincristine Sulfate (1.0 mg/ml) >240 Please note that Carmustine (BCNU) and Thiotepa has low permeation times of 30.0 and 60.0 minutes respectively. Warning: Do not use with Carmustine and Thiotepa Opioid Drugs and Others Permeation Test White-Green Fentanyl Citrate Injection (100mcg/2mL) >240 Simulated Gastric Acid >240 Xylazine HCI (100 mg/ml) >240 A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, Xylazine HCI, and Simulated Gastric Acid as per ASTM D6978-05 (Reapproved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drugs Permeation Test Minimum Breakthrough Detection Time in Minutes Chemotherapy Drugs (Concentration) White-Blue Carmustine (BCNU) (3.3 mg/ml) 30.0 (40.0, 30.0, 40.0) Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (Cytoxan) (20.0 mg/ml) >240 Cytarabine HCI (100 mg/ml) >240 Dacarbazine (DTIC) (10.0 mg/ml) >240 Doxorubicin Hydrochloride (2.0 mg/ml) >240 Etoposide (20.0 mg/ml) >240 Fluorouracil (50.0 mg/ml) >240 Ifosfamide (50.0 mg/ml) >240 Methotrexate (25.0 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Mitoxantrone (2.0 mg/ml) >240 Paclitaxel (Taxol) (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 80.0 (100.0, 80.0, 80.0) Vincristine Sulfate (1.0 mg/ml) >240 Please note that Carmustine (BCNU) and Thiotepa has low permeation times of 30.0 and 80.0 minutes respectively. Warning: Do not use with Carmustine and Thiotepa Opioid Drugs and Others Permeation Test White-Blue Fentanyl Citrate Injection (100mcg/2mL) >240 Simulated Gastric Acid >240 Xylazine HCI (100 mg/ml) >240

Source page: https://510kreport.com/device/K252549
Methodology: https://510kreport.com/methodology