510(k) · Cleared
ClearedHalyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
0 & M Halyard, Inc. · LZC Medical Glove, Specialty
Cleared on Oct 11, 2020 as substantially equivalent to K153708 (Halyard Health, 2016) and 1 other predicate after a 215-day review. Its family tree reaches back 3 generations to 2005. 4 later devices descend from it.
- Decided
- Oct 11, 2020
- Review
- 215 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K051347 (2005). 7 ancestors in all, the oldest K992162 (1999). 4 later devices descend from it, 2 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 deviceK200633 Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple…0 & M Halyard, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK213929 Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with…O&M Halyard, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK220547 PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA…O&M Halyard, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK262014 PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO*…O&M Halyard, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241909 Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis…O&M Halyard, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K213929Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs…O&M Halyard, Inc. · 2022 · cites it directly1descendant
- K220547PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free…O&M Halyard, Inc. · 2022 · cites it directly1descendant
- K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile…O&M Halyard, Inc. · 2026 · 2 generations on0descendants
- K241909Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for…O&M Halyard, Inc. · 2024 · 2 generations on0descendants
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) | K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free… | 0 & M Halyard, Inc. | 2020 | — |
| +1 | K213929 | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with… | O&M Halyard, Inc. | 2022 | — |
| +1 | K220547 | PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile… | O&M Halyard, Inc. | 2022 | — |
| +2 | K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA*… | O&M Halyard, Inc. | 2026 | — |
| +2 | K241909 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential… | O&M Halyard, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K153708 | Halyard Black-Orange Powder-Free Nitrile Exam GloveSummary page 6…Classification: Class I Regulation: 21 CFR §880.6250 Predicate Device1: K153708 Halyard Black-Orange Powder-Free Nitrile Exam Glove Predicate Device2:… | 2016 |
| * | K101596 | Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and…Summary page 6…K153708 Halyard Black-Orange Powder-Free Nitrile Exam Glove Predicate Device2: K101596 Kimberly-Clark PURPLE NITRILE Powder-Free Exam Glove with Tested for… | 2010 |
What descends from it? (4)
2 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 15 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K213929 (O&M Halyard, Inc., 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Halyard Black Fire Powder-Free Nitrile Exam Glove tested with Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. The following drugs showed not breakthrough at 240 minutes: Fentanyl Citrate, 100 mcg/2ml The Halyard Purple Nitrile Powder-Free Exam Glove tested with Chemotherapy Drugs and Fentanyl Citrate is a disposable device intended for…
Read the full statement (214 words)
The Halyard Black Fire Powder-Free Nitrile Exam Glove tested with Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner.
The following drugs showed not breakthrough at 240 minutes:
Fentanyl Citrate, 100 mcg/2ml
The Halyard Purple Nitrile Powder-Free Exam Glove tested with Chemotherapy Drugs and Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner.
The following drugs showed not breakthrough at 240 minutes:
Bleomycin (15.0 mg/ml)
Busulfan (6.0 mg/ml)
Carboplatin (10.0 mg/ml)
Cisplatin (1.0 mg/ml)
Cyclophosphamide (20.0 mg/ml)
Cytarabine (100.0 mg/ml)
Dacarbazine (DTIC) (10.0 mg/ml)
Daunorubicin (5.0 mg/ml)
Docetaxel (10.0 mg/ml)
Doxorubicin Hydrochloride (2.0 mg/ml)
Ellence (2.0 mg/ml)
Etoposide (Toposar) (20.0 mg/ml)
Fludarabine (25.0 mg/ml)
Fluorouracil (50.0 mg/ml)
Gemcitabine (Gemzar) (38.0 mg/ml)
Idarubicin (1.0 mg/ml)
Ifosfamide (50.0 mg/ml)
Irinotecan (20.0 mg/ml)
Mechlorethamine HCl (1.0 mg/ml)
Melphalan (5.0 mg/ml)
Methotrexate (25.0 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone (2.0 mg/ml)
Paclitaxel (Taxol) (6.0 mg/ml)
Paraplatin (10.0 mg/ml)
Rituximab (10.0 mg/ml)
Trisonex (1.0 mg/ml)
Vincrinstine (1mg/ml)
Fentanyl Citrate, 100 mcg/2ml
The following drugs showed breakthrough detected in less than 30 minutes: Carmustine (3.3mg/ml) 1.8 minutes and ThioTEPA (10.0mg/ml): 1.7 minutes.
Warning- Not for use with Carmustine and ThioTEPA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200633 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200633: Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200633
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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