# K201748: Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega Sdn Bhd
- Decided: Oct 2, 2020 after 98 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.
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
Latex Powder Free Surgical Glove with Protein Labelling 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 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes Carmustine (3.3 mg/ml) 13.1 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (20.0 mg/ml) >240 Dacarbazine (10.0 mg/ml) >240 Doxorubicin Hydrochloride (2.0 mg/ml) >240 Etoposide (20.0 mg/ml) >240 Fluorouracil (50.0 mg/ml) >240 Methotrexate (25.0 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Paclitaxel (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 15.7 Vincristine Sulfate (1.0 mg/ml) >240 Please note that Carmustine and Thiotepa have extremely low permeation times of 13.1 minutes and 15.7 minutes respectively. WARNING: Do Not Use With: Carmustine and Thiotepa

Source page: https://510kreport.com/device/K201748
Methodology: https://510kreport.com/methodology