510(k) · Cleared
ClearedKimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corp. · LZA Polymer Patient Examination Glove
Cleared on Mar 9, 2012 as substantially equivalent to K102032 (Kimberly-Clark Corp., 2010) and 1 other predicate after a 109-day review. Its family tree reaches back 3 generations to 2005. 5 later devices descend from it.
- Decided
- Mar 9, 2012
- Review
- 109 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K051347 (2005). 9 ancestors in all, the oldest K992062 (1999). 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK051347 Kimberly-Clark* Sterling* Nitrile Powder-Free Examination GloveKimberly-Clark Corp. · 2005
- 2 generations backK081260 Kimberly-Clark *Lavender* Nitrile Power-Free Exam GlovesKimberly-Clark Corp. · 2008
- 1 generation backK101596 Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy…Kimberly-Clark · 2010
- This deviceK113423 Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free…Kimberly-Clark Corp. · 2012
- Descendant · cites it directly · 2 of its ownK160709 HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health · 2016
- Descendant · 2 generations on · 0 of its ownK243604 Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis…O&M Halyard, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK182096 Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with…Owens & Minor Halyard, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK162294 Brightway Brand Nitrile Examination Gloves 12”, Powder Free…Brightway Holdings Sdn. Bhd. · 2017
- Descendant · cites it directly · 0 of its ownK162381 HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with…Healthy Glove Co., Ltd. · 2017
Most influential descendants
Showing 5 of 5 · See all- K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health · 2016 · cites it directly2descendants
- K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested…O&M Halyard, Inc. · 2025 · 2 generations on0descendants
- K182096Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy DrugsOwens & Minor Halyard, Inc. · 2018 · 2 generations on0descendants
- K162294Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Purple] Tested for Use…Brightway Holdings Sdn. Bhd. · 2017 · cites it directly0descendants
- K162381HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy DrugsHealthy Glove Co., Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K051347 | Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove | Kimberly-Clark Corp. | 2005 | — |
| −2 | K081260 | Kimberly-Clark *Lavender* Nitrile Power-Free Exam Gloves | Kimberly-Clark Corp. | 2008 | — |
| −1 | K101596 | Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and… | Kimberly-Clark | 2010 | — |
| 0 (this device) | K113423 | Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove | Kimberly-Clark Corp. | 2012 | — |
| +1 | K160709 | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves | Halyard Health | 2016 | — |
| +2 | K243604 | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis… | O&M Halyard, Inc. | 2025 | — |
| +2 | K182096 | Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy… | Owens & Minor Halyard, Inc. | 2018 | — |
| +1 | K162294 | Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Purple] Tested… | Brightway Holdings Sdn. Bhd. | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K102032 | Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove)…Summary page 1…, Polymer Patient Examination Glove (Product Code LZA) Legally Marketed Device(s) to Which Substantial Equivalence is Claimed: 1. K102032: Kimberly-Clark PURPLE NITRILE XTRA* Sterile Powder-Free Exam Gloves (Tested for Use with Chemotherapy Drugs - 12" Pairs);… | 2010 |
| * | K101596 | Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and…Summary page 5…es); Kimberly-Clark PURPLE NITRILE XTRA* Sterile Powder-Free Exam Gloves (12' Pairs); Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (9.5" Singles); 2. K101596: Kimberly-Clark PURPLE NITRILE XTRA* Powder-Free Exam Gloves (Tested for Use with Chemotherapy Drugs - 121); Kimberly-Clar… | 2010 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K160709 (Halyard Health, 2016) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K102032.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05: The following drugs had NO breakthrough detected up to 240 minutes: Bleomycin sulfate (15 mg/ml) Gemcitabine HCl (38.0mg/ml) Busulfan (6 mg/ml)…
Read the full statement (225 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 chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05:
The following drugs had NO breakthrough detected up to 240 minutes:
Bleomycin sulfate (15 mg/ml) Gemcitabine HCl (38.0mg/ml)
Busulfan (6 mg/ml) Idarubicin HCl (1.0mg/ml)
Carboplatin (10 mg/ml) Ifosfamide (50.0 mg/ml)
Cisplatin (1.0 mg/ml) Irinotecan HCl (20.0 mg/ml)
Cyclophosphamide (20.0 mg/ml) Mechlorethamine HCl (1.0 mg/ml)
Cytarabine HCl (100 mg/ml) Melphalan (5mg/ml)
Dacarbazine (10 mg/ml) Methotrexate (25 mg/ml)
Daunorubicin HCl (5.0 mg/ml) Mitomycin-C (0.5 mg/ml)
Docetaxel (10.0 mg/ml) Mitoxantrone (2.0 mg/ml)
Doxorubicin HCl (2.0 mg/ml) Paclitaxel (6.0 mg/ml)
Epirubicin (Ellence) (2mg/ml) Rituximab (10 mg/ml)
Etoposide (20.0 mg/ml) ThioTEPA (10.0 mg/ml)
Fludarabine (25 mg/ml) Trisenox (0.1 mg/ml)
Fluorouracil (50.0 mg/ml) Vincristine Sulfate (1.0 mg/ml)
Please note that the following drug has low permeation times of less than 60 minutes:
Carmustine (3.3 mg/ml) 30.7 minutes
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.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113423: Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113423
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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