# K182176: Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Medisafe Technologies
- Decided: Mar 28, 2019 after 230 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.
13 later devices descend from it; 1 cites it directly.
0 of 14 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
- K190860: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color (2019), 12 descendants of its own
- K230847: Chemotherapy Gloves (2023), 0 descendants of its own
- K214056: Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) (2022), 0 descendants of its own
- K221271: Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) (2022), 0 descendants of its own
- K220488: Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) (2022), 0 descendants of its own

## Indications for use
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below. Test Chemotherapy Drug and Concentration Breakthrough Detection Time (Minutes) Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 37.5 (47.8, 38.3, 37.5) Cisplatin 1.0 mg/ml (1,000ppm) >240 min Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) >240 min Dacarabzine (DTIC) 10.0 mg/ml (10,000 ppm) >240 min Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) >240 min Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) >240 min Fluorouracil 50.0 mg/ml (50,000 ppm) >240 min Ifosfamide 50.0 mg/ml (50,000 ppm) >240 min Methotrexate 25 mg/ml (25, 000 ppm) >240 min Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) >240 min Melphalan 5 mg/ml (5,000 ppm) >240 min Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) >240 min Thiotepa 10.0 mg/ml (10,000 ppm) 58.3 (69.8, 68.6, 58.3) Vincristine Sulfate 1.0 mg/ml (1,000 ppm) >240 min Please note that the following drugs have low permeation times: Carmustine (3.3 mg/ml): 37.5 minutes ThioTEPA (10.0 mg/ml): 58.3 minutes

Source page: https://510kreport.com/device/K182176
Methodology: https://510kreport.com/methodology