510(k) · Cleared
ClearedKimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove) - 12 Sterile Pairs
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 Sep 8, 2010 as substantially equivalent to K992062 (Safeskin Corp., 1999) and 3 other predicates after a 51-day review. Its family tree reaches back 2 generations to 1999. 8 later devices descend from it.
- Decided
- Sep 8, 2010
- Review
- 51 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K992062 (1999). 6 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK992062 Safeskin Sterile Purple Nitrile Examination GlovesSafeskin Corp. · 1999
- 1 generation backK081027 Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile)Kimberly-Clark Corp. · 2008 · Recalled
- This deviceK102032 Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove…Kimberly-Clark Corp. · 2010
- Descendant · cites it directly · 5 of its ownK113423 Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free…Kimberly-Clark Corp. · 2012
- Descendant · 2 generations on · 2 of its ownK160709 HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health · 2016
- Descendant · 3 generations on · 0 of its ownK243604 Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis…O&M Halyard, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK243172 Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs…O&M Halyard, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK192241 Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential…O&M Haylard, Inc. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K113423Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam GloveKimberly-Clark Corp. · 2012 · cites it directly5descendants
- K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health · 2016 · 2 generations on2descendants
- K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested…O&M Halyard, Inc. · 2025 · 3 generations on0descendants
- K243172Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile*…O&M Halyard, Inc. · 2025 · cites it directly0descendants
- K192241Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam…O&M Haylard, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992062 | Safeskin Sterile Purple Nitrile Examination Gloves | Safeskin Corp. | 1999 | — |
| −1 | K081027 | Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile) | Kimberly-Clark Corp. | 2008 | 1 |
| 0 (this device) | K102032 | Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove… | Kimberly-Clark Corp. | 2010 | — |
| +1 | K113423 | Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove | Kimberly-Clark Corp. | 2012 | — |
| +2 | K160709 | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves | Halyard Health | 2016 | — |
| +3 | K243604 | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis… | O&M Halyard, Inc. | 2025 | — |
| +1 | K243172 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple… | O&M Halyard, Inc. | 2025 | — |
| +1 | K192241 | Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free… | O&M Haylard, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K992062 | Safeskin Sterile Purple Nitrile Examination GlovesSummary page 3…ove (Product Code LZA) Legally Marketed Device(s) to Which Substantial Equivalence is Claimed: 1. Safeskin Sterile PURPLE NITRILE* Examination Gloves (Powder-Free) - K992062 2. Safeskin PURPLE* Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim - K99216… | 1999 |
| * | K992162 | Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic…Summary page 3…LE* Examination Gloves (Powder-Free) - K992062 2. Safeskin PURPLE* Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim - K992162 3. Kimberly-Clark Sterling Nitrile & Nitrile Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim - K081089… | 1999 |
| * | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy…Summary page 1…therapeutic Drugs Labeling Claim - K(992162 3. Kimberly-Clark Sterling Nitrile & Nitrile Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim - K081 089 4. Kimberly-Clark Sterile Sterling Nitrile Powder-Free Exam Glove - K081027 Device Description(s): Kimberly-Clark PURPLE NlTR… | 2008 |
| * | K081027 | Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile)Summary page 1…Nitrile & Nitrile Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim - K081 089 4. Kimberly-Clark Sterile Sterling Nitrile Powder-Free Exam Glove - K081027 Device Description(s): Kimberly-Clark PURPLE NlTRILE-XTRA*, Sterile Powder-Free Exam Gloves are 12-inch long, sterile, purple-co… | 2008 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113423 | Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove | 2012 | 5 |
| K243172 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile*… | 2025 | 0 |
| K192241 | Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam… | 2020 | 0 |
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 11 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K113423 (Kimberly-Clark Corp., 2012) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K992062.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 (15.0mg/ml) Idarubicin (1.0mg/ml) Busulfan (6.0mg/ml)…
Read the full statement (552 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 (15.0mg/ml) Idarubicin (1.0mg/ml)
Busulfan (6.0mg/ml) Ifosfamide (50mg/ml)
Carboplatin (10.0mg/ml) Irinotecan (20.0mg/ml)
Cisplatin (1 mg/ml) Mechlorethamine HCl (1.0mg/ml)
Cyclophosphamide (20 mg/ml) Melphalan (5.0mg/ml)
Cytarabine HCl (100.0mg/ml) Methotrexate (25.0mg/ml)
Dacarbazine (10 mg/ml) Mitomycin (0.5mg/ml)
Daunorubicin HCl (5.0mg/ml) Mitoxantrone (2 mg/ml)
Docetaxel (10.0mg/ml) Paclitaxel (Taxol) (6 mg/ml)
Doxorubicin HCl (Adriamycin) (2 mg/ml) Paraplatin (10.0mg/ml)
Ellence (Epirubicin) (2.0mg/ml) Rituximab (10.0mg/ml)
Etoposide (20 mg/ml) ThioTEPA (10.0mg/ml)
Fludarabine (25.0mg/ml) Trisenox (0.1mg/ml)
Fluorouracil (adrucil) (50 mg/ml) Vincristine Sulfate (1 mg/ml)
Gemcitabine (38.0mg/ml)
Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 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.
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 (15.0mg/ml) Idarubicin (1.0mg/ml)
Busulfan (6.0mg/ml) Ifosfamide (50mg/ml)
Carboplatin (10.0mg/ml) Irinotecan (20.0mg/ml)
Cisplatin (1 mg/ml) Mechlorethamine HCl (1.0mg/ml)
Cyclophosphamide (20 mg/ml) Melphalan (5.0mg/ml)
Cytarabine HCl (100.0mg/ml) Methotrexate (25.0mg/ml)
Dacarbazine (10 mg/ml) Mitomycin (0.5mg/ml)
Daunorubicin HCl (5.0mg/ml) Mitoxantrone (2 mg/ml)
Docetaxel (10.0mg/ml) Paclitaxel (Taxol) (6 mg/ml)
Doxorubicin HCl (Adriamycin) (2 mg/ml) Paraplatin (10.0mg/ml)
Ellence (Epirubicin) (2.0mg/ml) Rituximab (10.0mg/ml)
Etoposide (20 mg/ml) ThioTEPA (10.0mg/ml)
Fludarabine (25.0mg/ml) Trisenox (0.1mg/ml)
Fluorouracil (adrucil) (50 mg/ml) Vincristine Sulfate (1 mg/ml)
Gemcitabine (38.0mg/ml)
Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 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.
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 (15.0mg/ml) Idarubicin (1.0mg/ml)
Busulfan (6.0mg/ml) Ifosfamide (50mg/ml)
Carboplatin (10.0mg/ml) Irinotecan (20.0mg/ml)
Cisplatin (1 mg/ml) Mechlorethamine HCl (1.0mg/ml)
Cyclophosphamide (20 mg/ml) Melphalan (5.0mg/ml)
Cytarabine HCl (100.0mg/ml) Methotrexate (25.0mg/ml)
Dacarbazine (10 mg/ml) Mitomycin (0.5mg/ml)
Daunorubicin HCl (5.0mg/ml) Mitoxantrone (2 mg/ml)
Docetaxel (10.0mg/ml) Paclitaxel (Taxol) (6 mg/ml)
Doxorubicin HCl (Adriamycin) (2 mg/ml) Paraplatin (10.0mg/ml)
Ellence (Epirubicin) (2.0mg/ml) Rituximab (10.0mg/ml)
Etoposide (20 mg/ml) ThioTEPA (10.0mg/ml)
Fludarabine (25.0mg/ml) Trisenox (0.1mg/ml)
Fluorouracil (adrucil) (50 mg/ml) Vincristine Sulfate (1 mg/ml)
Gemcitabine (38.0mg/ml)
Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 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.
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/K102032 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102032: Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove) - 12 Sterile Pairs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102032
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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