# K162381: HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Healthy Glove Co., Ltd.
- Decided: Jan 31, 2017 after 160 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K051347 (2005). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113423: Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove, Kimberly-Clark Corp. (2012) Summary page 5.

## Indications for use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with the following chemotherapy drugs at specific concentrations as per ASTM D6978-035 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The gloves have been tested with the following drugs and the respective breakthrough detection times are listed below. Blenoxane (15 mg/ml) — > 240 minutes Busulfan (6 mg/ml) — > 240 minutes Carboplatin (10 mg/ml) — > 240 minutes Carmustine (BCNU) (3.3 mg/ml) — 30.4 minutes Cisplatin (1.0 mg/ml) — > 240 minutes Cyclophosphamide (Cytoxan) (20 mg/ml) — > 240 minutes Cytarabine (100 mg/ml) — > 240 minutes Dacarbazine (DTIC) (10.0 mg/ml) — > 240 minutes Daunorubicin (3 mg/ml) — > 240 minutes Docetaxel (10.0 mg/ml) — > 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml) — > 240 minutes Ellence (2 mg/ml) — > 240 minutes Etoposide (Toposar) (20.0 mg/ml) — > 240 minutes Fludarabine (25 mg/ml) — > 240 minutes Fluorouracil (50.0 mg/ml) — > 240 minutes Ganciclovir (10 mg/ml) — > 240 minutes Gemcitabine (Gemzar) (38 mg/ml) — > 240 minutes Idarubicin (1 mg/ml) — > 240 minutes Ifosfamide (50.0 mg/ml) — > 240 minutes Irinotecan (20.0 mg/ml) — > 240 minutes Mechlorethamine HCI (1.0 mg/ml) — > 240 minutes Melphalan (3 mg/ml) — > 240 minutes Methotrexate (25 mg/ml) — > 240 minutes Mitoxantrone (2.0mg/ml) — > 240 minutes Mitomycin C (0.5 mg/ml) — > 240 minutes Oxaliplatin (3 mg/ml) — > 240 minutes Paclitaxel (Taxol) (6.0 mg/mi) — > 240 minutes Rituximab (10 mg/ml) — > 240 minutes Thiotepa (10.0 mg/ml) — > 240 minutes Trisenox (0.1 mg/ml) — > 240 minutes Vincristine Sulfate (1.0 mg/ml) — > 240 minutes Vinorelbine (10 mg/ml) — > 240 minutes Please note that the following drug has extremely low permeation time: Carmustine (BCNU) (3.3 mg/ml) at 30.4 minutes

Source page: https://510kreport.com/device/K162381
Methodology: https://510kreport.com/methodology