510(k) · Cleared
ClearedHG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthy Glove Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Jan 31, 2017 as substantially equivalent to K113423 (Kimberly-Clark Corp., 2012) after a 160-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Jan 31, 2017
- Review
- 160 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K051347 (2005). 10 ancestors in all, the oldest K992062 (1999). No later device cites it as a predicate yet.
- Root · 4 generations backK051347 Kimberly-Clark* Sterling* Nitrile Powder-Free Examination GloveKimberly-Clark Corp. · 2005
- 3 generations backK081260 Kimberly-Clark *Lavender* Nitrile Power-Free Exam GlovesKimberly-Clark Corp. · 2008
- 2 generations backK101596 Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy…Kimberly-Clark · 2010
- 1 generation backK113423 Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free…Kimberly-Clark Corp. · 2012
- This deviceK162381 HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with…Healthy Glove Co., Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K051347 | Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove | Kimberly-Clark Corp. | 2005 | — |
| −3 | K081260 | Kimberly-Clark *Lavender* Nitrile Power-Free Exam Gloves | Kimberly-Clark Corp. | 2008 | — |
| −2 | K101596 | Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and… | Kimberly-Clark | 2010 | — |
| −1 | K113423 | Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove | Kimberly-Clark Corp. | 2012 | — |
| 0 (this device) | K162381 | HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with… | Healthy Glove Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZA device
- #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113423 | Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam GloveSummary page 5…Kimberly Clark Corporation Device Name: PURPLE NlTRlLE-XTRA* Powder-Free Exam - 12' Length 510(k): K113423 Regulatory Class: I Classification Name: Patient Examination Gloves (21 CFR 880.62… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 2 other devices also cite its predicate K113423.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LZA
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZA
110in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZA
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZA
73in 2025
MAUDE reports naming product code LZA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 95 | 0 | 7 |
| 2008 | 18 | 97 | 0 | 2 |
| 2009 | 28 | 112 | 0 | 12 |
| 2010 | 31 | 97 | 0 | 12 |
| 2011 | 26 | 122 | 0 | 9 |
| 2012 | 33 | 110 | 0 | 11 |
| 2013 | 20 | 130 | 0 | 10 |
| 2014 | 27 | 197 | 0 | 8 |
| 2015 | 20 | 112 | 1 | 12 |
| 2016 | 30 | 171 | 1 | 25 |
| 2017 | 44 | 124 | 0 | 4 |
| 2018 | 22 | 178 | 0 | 3 |
| 2019 | 25 | 212 | 0 | 21 |
| 2020 | 30 | 101 | 0 | 4 |
| 2021 | 139 | 111 | 0 | 20 |
| 2022 | 146 | 111 | 0 | 19 |
| 2023 | 62 | 92 | 0 | 24 |
| 2024 | 30 | 89 | 0 | 76 |
| 2025 | 24 | 110 | 0 | 73 |
| 2026 | 15 | 103 | 3 | — |
What is it indicated for?
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…
Read the full statement (329 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162381: HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162381
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026