# K222129: Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

- Pathway: 510(k) (Traditional)
- Applicant: Top Glove Medical (Thailand) Co., Ltd.
- Decided: Feb 10, 2023 after 207 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
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
An examination glove is a disposable glove intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. No Test Chemotherapy Drug — Concentration (mg/ml) — Minimum breakthrough Detection Time (min) 1 Blenoxane — 15 — >240 2 Busulfan — 6 — >240 3 Carboplatin — 10 — >240 4 Carmustine (BCNU) — 3.3 — 16.7 5 Cisplatin — 1 — >240 6 Cyclophosphamide — 20 — >240 7 Cytarabine — 100 — >240 8 Dacarbazine — 10 — >240 9 Daunorubicin HCl — 5 — >240 10 Docetaxel — 10 — >240 11 Doxorubicin HCl — 2.0 — >240 12 Etoposide — 20 — >240 13 Ellence — 2 — >240 14 Fludarabine — 25 — >240 15 Fluorouracil — 50 — >240 16 Ganciclovir — 10 — >240 17 Gemcitabine — 38 — >240 18 Idarubicin HCl — 1 — >240 19 lfosfamide — 50 — >240 20 Irinotecan — 20 — >240 21 Mechlorethamine HCl — 1 — >240 22 Melphalan — 5 — >240 23 Methotrexate — 25 — >240 24 Mitomycin C — 0.5 — >240 25 Mitoxantrone HCl — 2 — >240 26 Oxaliplatin — 5 — >240 27 Paclitaxel — 6.0 — >240 28 Rituximab — 10 — >240 29 Thiotepa — 10.0 — 35.0 30 Trisenox — 1 — >240 31 Vincristine Sulfate — 1 — >240 32 Vinorelbine — 10 — >240 Test Drug — Concentration — Minimum breakthrough Detection Time (min) Fentanyl Citrate — 100 mcg/2ml — >240 Please note that Carmustine and Thiotepa have extremely low permeation times of 16.7 minutes and 35 minutes respectively. WARNING: Do not use Carmustine CAUTION: Testing showed an average breakthrough time of35 minutes with Thiotepa. An examination glove is a disposable glove intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. No Test Chemotherapy Drug — Concentration (mg/ml) — Minimum breakthrough Detection Time (min) 1 Blenoxane — 15 — >240 2 Busulfan — 6 — >240 3 Carboplatin — 10 — >240 4 Carmustine (BCNU) — 3.3 — 14.2 5 Cisplatin — 1 — >240 6 Cyclophosphamide — 20 — >240 7 Cytarabine — 100 — >240 8 Dacarbazine — 10 — >240 9 Daunorubicin HCl — 5 — >240 10 Docetaxel — 10 — >240 11 Doxorubicin HCl — 2.0 — >240 12 Etoposide — 20.0 — >240 13 Ellence — 2 — >240 14 Fludarabine — 2 — >240 15 Fluorouracil — 50 — >240 16 Ganciclovir — 10 — >240 17 Gemcitabine — 38 — >240 18 Idarubicin HCl — 1 — >240 19 lfosfamide — 50 — >240 20 Irinotecan — 20 — >240 21 Mechlorethamine HCl — 1 — >240 22 Melphalan — 5 — >240 23 Methotrexate — 25 — >240 24 Mitomycin C — 0.5 — >240 25 Mitoxantrone HCl — 2 — >240 26 Oxaliplatin — 5 — >240 27 Paclitaxel — 6.0 — >240 28 Rituximab — 10 — >240 29 Thiotepa — 10.0 — 24.1 30 Trisenox — 1 — >240 31 Vincristine Sulfate — 1 — >240 32 Vinorelbine — 10 — >240 Test Drug — Concentration — Minimum breakthrough Detection Time (min) Fentanyl Citrate — 100 mcg/2ml — >240 Please note that Carmustine and Thiotepa have extremely low permeation times of 14.2 minutes and 24.1 minutes respectively. WARNING: Do not use Carmustine and Thiotepa CAUTION: Testing showed an average breakthrough time of24.1 minutes with Thiotepa.

Source page: https://510kreport.com/device/K222129
Methodology: https://510kreport.com/methodology