# 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

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: May 26, 2022 after 150 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- 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 (2026), 0 descendants of its own

## Indications for use
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 is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) 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 (BCNU) (3.3 mg/ml) 12.5 Cisplatin (1 mg/ml) > 240 Cyclophosphamide (Cytoxan) (20.0 mg/ml) > 240 Dacarbazine (10 mg/ml) > 240 Doxorubicin HCI (2.0 mg/ml) > 240 Etoposide (20.0 mg/ml) > 240 Fluorouracil (50.0 mg/ml) > 240 Methotrexate (25 mg/ml) > 240 Mitomycin C (0.5 mg/ml) > 240 Paclitaxel (6.0 mg/ml) > 240 Thiotepa (10.0 mg/ml) 13.6 Vincristine Sulfate (1.0 mg/ml) > 240 Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 12.5 minutes; Thiotepa 10.0 mg/ml 13.6 minutes. Warning: Please do not use with Carmustine (BCNU) and Thiotepa.

Source page: https://510kreport.com/device/K214074
Methodology: https://510kreport.com/methodology