510(k) · Cleared
ClearedKimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and Kimberly-Clark Purple Nitrile Xtra Powder-
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark · LZC Medical Glove, Specialty
Cleared on Jul 21, 2010 as substantially equivalent to K992162 (Safeskin Corp., 1999) and 2 other predicates after a 43-day review. Its family tree reaches back 2 generations to 2005. 11 later devices descend from it.
- Decided
- Jul 21, 2010
- Review
- 43 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K051347 (2005). 5 ancestors in all, the oldest K992162 (1999). 11 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK051347 Kimberly-Clark* Sterling* Nitrile Powder-Free Examination GloveKimberly-Clark Corp. · 2005
- 1 generation backK081260 Kimberly-Clark *Lavender* Nitrile Power-Free Exam GlovesKimberly-Clark Corp. · 2008
- This deviceK101596 Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy…Kimberly-Clark · 2010
- Descendant · cites it directly · 5 of its ownK113423 Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free…Kimberly-Clark Corp. · 2012
- Descendant · cites it directly · 4 of its ownK200633 Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple…0 & M Halyard, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK160709 HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health · 2016
- Descendant · 2 generations on · 1 of its ownK213929 Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with…O&M Halyard, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK220547 PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA…O&M Halyard, Inc. · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K113423Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam GloveKimberly-Clark Corp. · 2012 · cites it directly5descendants
- K200633Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile…0 & M Halyard, Inc. · 2020 · cites it directly4descendants
- K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health · 2016 · 2 generations on2descendants
- K213929Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs…O&M Halyard, Inc. · 2022 · 2 generations on1descendant
- K220547PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free…O&M Halyard, Inc. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051347 | Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove | Kimberly-Clark Corp. | 2005 | — |
| −1 | K081260 | Kimberly-Clark *Lavender* Nitrile Power-Free Exam Gloves | Kimberly-Clark Corp. | 2008 | — |
| 0 (this device) | 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 | — |
| +1 | K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free… | 0 & M Halyard, Inc. | 2020 | — |
| +2 | K160709 | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves | Halyard Health | 2016 | — |
| +2 | K213929 | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with… | O&M Halyard, Inc. | 2022 | — |
| +2 | K220547 | PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile… | O&M Halyard, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 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 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 LZC? 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 LZC device
- #1 K201390 Medline Powder-Free Light Blue Nitrile Exam…score 19.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K992162 | Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic…Summary page 1…) to Which Substantial Equivalence is Claimed: 1. Safeskirn Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim - K992162 2. Kimberly-Clark STEIRLING* Nitrile & STERLING* NITRILE-XTRA* Powder-Free Exam Gloves with Chemotherapy Drug Use Claim… | 1999 |
| * | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy…Summary page 1…rugs Labeling Claim - K992162 2. Kimberly-Clark STEIRLING* Nitrile & STERLING* NITRILE-XTRA* Powder-Free Exam Gloves with Chemotherapy Drug Use Claim - K081089 3. Kimberly-Clark LAVENDER* Nitrile Powder-Free Examination Glove - K081260 Device Description(s): Kimberly-Clark PURPLE… | 2008 |
| * | K081260 | Kimberly-Clark *Lavender* Nitrile Power-Free Exam GlovesSummary page 1…STERLING* NITRILE-XTRA* Powder-Free Exam Gloves with Chemotherapy Drug Use Claim - K081089 3. Kimberly-Clark LAVENDER* Nitrile Powder-Free Examination Glove - K081260 Device Description(s): Kimberly-Clark PURPLE NITRILE-XTRA t Powder-Free Exam Gloves (Chemotherapy Glove) are 12- inch lon… | 2008 |
What descends from it? (11)
See all 112 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 5 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K113423 (Kimberly-Clark Corp., 2012) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K992162.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LZC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZC
85in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZC
10in 2025
MAUDE reports naming product code LZC, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 166 | 1 | 0 |
| 2009 | 5 | 253 | 0 | 1 |
| 2010 | 5 | 68 | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 4 | 149 | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 258 | 0 | 5 |
| 2017 | 6 | 121 | 0 | 7 |
| 2018 | 6 | 105 | 0 | 6 |
| 2019 | 7 | 200 | 0 | 8 |
| 2020 | 3 | 167 | 0 | 1 |
| 2021 | 3 | 94 | 1 | 2 |
| 2022 | 7 | 85 | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 1 | — |
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 ding concentrations per ASTM D6978-05: The following drugs had NO breakthrough detected up to 240 minutes: Bleomycin sulfate (15.0mg/ml) Gemacitabine (38.0mg/mI) Busulifa (6.0mg/mi)…
Read the full statement (380 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 ding concentrations per ASTM D6978-05:
The following drugs had NO breakthrough detected up to 240 minutes:
Bleomycin sulfate (15.0mg/ml) Gemacitabine (38.0mg/mI)
Busulifa (6.0mg/mi) Idarubicin (1.0mg/mi)
Carboplatin (10.0mg/mi) Ifosfamide (50mg/mi)
Cispiatin (I mg/ml) Irinotecan (20.0mg/mi)
Cyclophosphamide (20 mg/mi) Mechlorethamine HCl (1.0mg/mil)
Cytarabine HG! (100.0mg/mi) Melphalan (5.0mg/mI)
Dacarbazine (10 mg/mi) Methotrexate (25.0mg/mi)
Daunorubicin Hel (5.0mg/mi) Mitomycin (0.5mg/mi)
Docetaxel (10.0mg/mI) Mitoxantrone (2 mg/mi)
Doxorubicin HCI (Adriamycin) (2 mg/mi) Paclitaxei (Taxoi) (6 mg/mi)
Elience (Epirubicin) (2.0mg/mil) Parapiatin (10.0mg/mi)
Etoposide (20 mg/mI) Rituximab (10.0mg/mi)
Fludarabine (25.0mg/mi) Trisenox (0.1Img/mi)
Fluorouracil (adrucil) (50 mg/ml) Vincrinstine Suifate (I mg/mI)
The following drugs showed breakthrough detected in less than' 30 minutes:
Carmustine (3.3mg/ml) :1.8 minutes IThioTEPA l1O.Omg/ml):1. iue
Warning - Not for Use with Carmustine and ThioTEPA
A powder-free patient examination glove is a disposable devi ce 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 deetd up to 240 minutes:
Bleomycin sulfate (1 5.0mg/mi) Gemcitabine (38.0mg/mi)
Busulfan (6.0mg/mi) Idarubicin (1.0mg/mi)
Carboplatin (10.0mg/nd) Ifosfamide (50mg/mi)
Cispiatin (1 mg/mi) Irinotecan (20.0mg/mi)
Cyclophosphamide (20 mg/mi) Mechlorethamnine HCI (1.0mng/mi)
Cytarabine HCi (100.0mg/mi) Melphalan (5.0mg/mi)
Dacarbazine (10 mg/mi) Methotrexate (25.0mg/mi)
Daunorubicin Hci (5.0mg/mi) Mitomycin (0.5mg/mi)
Docetaxel (iO.Omg/mi) Mitoxantrone (2 mg/ml)
Doxorubicin HC1 (Adriamycin) (2 mg/ml) Paclitaxel (Taxoi) (6 mg/ndl)
Ellence (Epirubicin) (2.0mg/mi) Parapatin (10.0mg/mi)
Etoposide (20 mg/mi) Rituximab (10.0mg/mi)
Fludarabine (25.0mg/mi) 1Trisenox (0. 1mg/md)
Fluorouracil (adrucil) (50 mg/mi) IVincrinstine Sulfate (1 mg/mil)
The following drugs showed breakthrough detected in less than 30 minutes:
Carmustine (3.3mg/mI) :1.8 minutes ThioTEPA (10.Omg/ml) :1.7 minutes
Warning - Not for Use with Carmustine and ThioTEPA
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/K101596 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101596: Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and Kimberly-Clark Purple Nitrile Xtra Powder-.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101596
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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