# K250313: Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

- Pathway: 510(k) (Abbreviated)
- Applicant: Harps Europe Manufacturing GmbH
- Decided: Aug 19, 2025 after 197 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: 3 generations back to K981096 (1998). 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)
- K160781: Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves, Semperit Investments Asia Pte, Ltd. (2017) Summary page 6.

## Indications for use
The Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination. The tested drugs are: Compound Minimum Breakthrough Time (minutes) Carmustine (BCNU) (3.3 mg/ml) 15.8 Cyclophosphamide (20 mg/ml) >240 Doxorubicin (2 mg/ml) >240 Etoposide (Toposar) (20 mg/ml) >240 Fluorouracil (50 mg/ml) >240 Paclitaxel (6 mg/ml) >240 Thiotepa (THT) (10 mg/ml) 24.6 Bleomycin sulfate (15 mg/ml) >240 Carboplatin (10 mg/ml) >240 Cisplatin (1 mg/ml) >240 Cytarabine (100 mg/ml) >240 Dacarbazine (10 mg/ml) >240 Daunorubicin HCl (5 mg/ml) >240 Docetaxel (10 mg/ml) >240 Gemcitabine HCl (38 mg/ml) >240 Idarubicin HCl (1 mg/ml) >240 Ifosfamide (50 mg/ml) >240 Irinotecan HCl (20 mg/ml) >240 Mechlorethamine HCl (1 mg/ml) >240 Melphalan HCl (5 mg/ml) >240 Methotrexate (25 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Mitoxantrone (2 mg/ml) >240 Vincristine Sulfate (1 mg/ml) >240 Busulfan (6 mg/ml) >240 Chloroquine (50 mg/ml) >240 Cyclosporin A (100 mg/ml) >240 Epirubicin HCl (2 mg/ml) >240 Fludarabine Phosphate (25 mg/ml) >240 Oxaliplatin (2 mg/ml) >240 Retrovir (10 mg/ml) >240 Rituximab (10 mg/ml) >240 Topotecan HCl (1 mg/ml) >240 Trisenox (Arsenic Trioxide) (1 mg/ml) >240 Velcade (Bortezomib) (1 mg/ml) >240 Simulated Gastric Acid Fluid was also tested with a minimum breakthrough greater than 240 minutes. WARNING: Please note the following drugs have extremely low permeation times: Carmustine: 15.8 minutes and Thiotepa: 24.6 minutes. Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K250313
Methodology: https://510kreport.com/methodology