# K162852: Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove

- Pathway: 510(k) (Traditional)
- Applicant: Lucenxia Prescience AG
- Decided: Feb 8, 2017 after 120 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
This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination. Flexylon; a styrene-ethylene/butylene-styrene (SEBS) material. These Gloves are tested for use with Chemotherapy Drugs DO NOT USE with Carmustine or Thiotepa Chemical Resistance Data per ASTM D 6978-05 Drug Minimum Breakthrough Detection Time (minutes) Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) .......c.coovvvvrermrerrerernn, 15.3 Eispiatin-10:mp/ml (1000 oM. i e e 240 Cyclophosphamide (cytoxan) 20 mg/ml (20,000 ppm)......................... 240 Bacarbazine (DTIC) 10.0'mg/ml (10,000)......:cccouersvosionsossorsomsnssiomiies 240 Doxorubincin Hydrochloride 2.0 mg/ml (2,000 ppm)...........c............. 240 Etoposide (Toposar) 20.0 mg/ml (20,000 ppm)..........cccovevrrererneren, 240 Hioronmcil 50.0mg/ml (50:000.ppm)........... it e 240 Ifosfamide 50.0 mg/ml (50,000 ppm)..........ccvccoieeimmiimsiniennssssesssssnsennas 240 Msthatrexate 25 mg/mli(25:000ppm):..co s 240 MHemycin C 0.5 mgmBEGO0PEm)s i e 240 Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm)........c.cooveeeeremeerererrernrnn, 240 pnatenal 0:0tmp/ml (10000 pPIm). oo e o 15.8 Vincristine Sulfate 1.0 mg/ml (1,000 ppm)..........ccovvervvevemerernerernnn. 240

Source page: https://510kreport.com/device/K162852
Methodology: https://510kreport.com/methodology