# K161929: Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Dipped Products (Thailand) Limited
- Decided: Mar 29, 2017 after 258 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: 3 generations back to K042805 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141982: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs, Wrp Asia Pacific Sdn. Bhd. (2015) Summary page 5.

## Indications for use
The Palm-pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove has also been tested for use with Chemotherapy Drugs. The following Chemotherapy drugs have been tested for use with these gloves in accordance with ASTM D6978-05: Chemotherapy drug (concentration) Breakthrough Detection Time Dacarbazine (10,000 ppm) No breakthrough up to 240 minutes *Carmustine (BCNU) (3,300 ppm) Breakthrough at 30.6 minutes Cyclophosphamide (20,000 ppm) No breakthrough up to 240 minutes Doxorubicin Hydrocloride (2,000 ppm) No breakthrough up to 240 minutes Fluorrouracil (5,000 ppm) No breakthrough up to 240 minutes Cisplatin (1,000 ppm) No breakthrough up to 240 minutes Etoposide (20,000 ppm) No breakthrough up to 240 minutes Paclitaxel (6,000 ppm) No breakthrough up to 240 minutes Thiotepa (10,000 ppm) Breakthrough at 181.3 minutes *Please note that the following drug has extremely low permeation times: Carmustine (BCNU): 30.6 minutes.

Source page: https://510kreport.com/device/K161929
Methodology: https://510kreport.com/methodology