# K260558: Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Jul 28, 2026 after 159 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K022442 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214074: Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs, Hartalega NGC Sdn. Bhd. (2022) Summary page 7.
- K032464: Aloetouch Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50, Wrp Asia Pacific Sdn. Bhd. (2003) Summary page 7.

## Indications for use
Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is made of natural rubber intended to be worn by operating personnel to protect surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate. The glove was tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes Carmustine (3.3 mg/ml) 6.7 Cisplatin (1.0 mg/ml) > 240 Cyclophosphamide (20.0 mg/ml) > 240 Dacarbazine (10.0 mg/ml) > 240 Doxorubicin HCI (2.0 mg/ml) > 240 Etoposide (20.0 mg/ml) > 240 Fluorouracil (50.0 mg/ml) > 240 Methotrexate (25.0 mg/ml) > 240 Mytomycin C (0.5 mg/ml) > 240 Paclitaxel (6.0 mg/ml) > 240 Thiotepa (10.0 mg/ml) 11.5 Vincristine Sulfate (1.0 mg/ml) > 240 Fentanyl Citrate and Concentration Minimum Breakthrough Detection Time in Minutes Fentanyl Citrate Injection (100mcg/2ml) >240 Caution: Testing showed a minimum breakthrough time of 6.7 minutes with Carmustine and 11.5 minutes with Thiotepa. Warning: Do not use with Carmustine and Thiotepa Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is made of natural rubber intended to be worn by operating personnel to protect surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate. The glove was tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes Carmustine (3.3 mg/ml) 7.7 Cisplatin (1.0 mg/ml) > 240 Cyclophosphamide (20.0 mg/ml) > 240 Dacarbazine (10.0 mg/ml) > 240 Doxorubicin HCI (2.0 mg/ml) > 240 Etoposide (20.0 mg/ml) > 240 Fluorouracil (50.0 mg/ml) > 240 Methotrexate (25.0 mg/ml) > 240 Mytomycin C (0.5 mg/ml) > 240 Paclitaxel (6.0 mg/ml) > 240 Thiotepa (10.0 mg/ml) 12.8 Vincristine Sulfate (1.0 mg/ml) > 240 Fentanyl Citrate and Concentration Minimum Breakthrough Detection Time in Minutes Fentanyl Citrate Injection (100mcg/2ml) >240 Caution: Testing showed a minimum breakthrough time of 7.7 minutes with Carmustine and 12.8 minutes with Thiotepa. Warning: Do not use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K260558
Methodology: https://510kreport.com/methodology