# K222993: Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Sentienx Sdn Bhd
- Decided: Aug 18, 2023 after 324 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
A powder-free surgeon's glove is a device made of synthetic elastomer that is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and ASTM D6355-07, Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves. Chemotherapy Drugs Permeation The following drugs have been tested with these gloves No. Chemotherapy Drugs Concentration Breakthrough Detection Time in Minutes 1. Carmustine 3.3 mg/ml 7.7 2. Cisplatin 1.0 mg/ml >240 3. Cyclophosphamide 20.0 mg/ml >240 4. Dacarbazine 10.0 mg/ml >240 5. Doxorubicin HCI 2.0 mg/ml >240 6. Etoposide 20.0 mg/ml >240 7. Fluorouracil 50.0 mg/ml >240 8. Ifosfamide 50.0 mg/ml >240 9. Methotrexate 25.0 mg/ml >240 10. Mitomycin C 0.5 mg/ml >240 11. Paclitaxel (Taxol) 6.0 mg/ml >240 12. Thiotepa 10.0 mg/ml 11.4 13. Vincristine Sulfate 1.0 mg/ml >240 Warning: The permeation times for Carmustine and Thiotepa are extremely low with permeation times of 7.7 minutes and 11.4 minutes respectively. Do not use with Carmustine or Thiotepa. A powder-free surgeon's glove is a device made of synthetic elastomer that is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and ASTM D6355-07, Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves. Chemotherapy Drugs Permeation The following drugs have been tested with these gloves No. Chemotherapy Drugs Concentration Breakthrough Detection Time in Minutes 1. Carmustine 3.3 mg/ml 11.9 2. Cisplatin 1.0 mg/ml >240 3. Cyclophosphamide 20.0 mg/ml >240 4. Dacarbazine 10.0 mg/ml >240 5. Doxorubicin HCI 2.0 mg/ml >240 6. Etoposide 20.0 mg/ml >240 7. Fluorouracil 50.0 mg/ml >240 8. Ifosfamide 50.0 mg/ml >240 9. Methotrexate 25.0 mg/ml >240 10. Mitomycin C 0.5 mg/ml >240 11. Paclitaxel (Taxol) 6.0 mg/ml >240 12. Thiotepa 10.0 mg/ml 12.3 13. Vincristine Sulfate 1.0 mg/ml >240 14. Bleomycin Sulfate 15.0 mg/ml >240 15. Busulfan 6.0 mg/ml >240 16. Carboplatin 10.0 mg/ml >240 17. Cytarabine HCI 100.0 mg/ml >240 18. Cytovene 10.0 mg/ml >240 19. Daunorubicin HCI 5.0 mg/ml >240 20. Docetaxel 10.0 mg/ml >240 21. Epirubicin HCI 2.0 mg/ml >240 22. Fludarabine 25.0 mg/ml >240 23. Gemcitabine (Gemzar) 38.0 mg/ml >240 24. Idarubicin HCI 1.0 mg/ml >240 25. Irinotecan 20.0 mg/ml >240 26. Mechlorethamine HCI 1.0 mg/ml >240 27. Melphalan 5.0 mg/ml >240 28. Mitoxantrone 2.0 mg/ml >240 29. Oxaliplatin 5.0 mg/ml >240 30. Rituximab 10.0 mg/ml >240 31. Trisenox 1.0 mg/ml >240 32. Vinorelbine 10.0 mg/ml >240 Warning : The permeation times for Carmustine and Thiotepa are extremely low with permeation times of 11.9 minutes and 12.3 minutes respectively. Do not use with Carmustine or Thiotepa.

Source page: https://510kreport.com/device/K222993
Methodology: https://510kreport.com/methodology