510(k) · Cleared
Recalled · Class II · 2026Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Nitrile Operations, LLC · LZA Polymer Patient Examination Glove
Cleared on Jul 8, 2022 as substantially equivalent to K200150 (Medline Industries, Inc., 2020) after a 109-day review. Its family tree reaches back 3 generations to 2009. It has been recalled 4 times.
- Decided
- Jul 8, 2022
- Review
- 109 days
- Class
- Class I
- Product code
- LZA
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 3 generations to K090194 (2009). No later device cites it as a predicate yet.
- Root · 3 generations backK090194 Powder- Free Nitrile Examination Gloves, Black ColorShen Wei (Usa), Inc. · 2009
- 2 generations backK120890 Powder-Free Nitrie Examination Gloves, OrangeShen Wei (Usa), Inc. · 2012
- 1 generation backK200150 Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested…Medline Industries, Inc. · 2020
- This deviceK220825 Sapphire Pro Powder-Free Royal Blue Nitrile Exam GlovesAmerican Nitrile Operations, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K090194 | Powder- Free Nitrile Examination Gloves, Black Color | Shen Wei (Usa), Inc. | 2009 | — |
| −2 | K120890 | Powder-Free Nitrie Examination Gloves, Orange | Shen Wei (Usa), Inc. | 2012 | — |
| −1 | K200150 | Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use… | Medline Industries, Inc. | 2020 | — |
| 0 (this device) | K220825 | Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves | American Nitrile Operations, LLC | 2022 | — |
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 |
|---|---|---|---|
| * | K200150 | Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with…Summary page 5…Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl) 510k Number K200150 510k Owner Medline Industries, Inc. Page 2 of 6 === Page… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 14, 2026 | Class II | Z-3291-2026 | Process control | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to… |
| Aug 14, 2026 | Class II | Z-3289-2026 | Process control | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to… |
| Aug 14, 2026 | Class II | Z-3290-2026 | Process control | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to… |
| May 13, 2024 | Class II | Z-2320-2024 | Under Investigation by firm | Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner box indicating… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. The list of Fentanyl and Chemotherapy Drugs tested (with breakthrough times) are…
Read the full statement (133 words)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs.
The list of Fentanyl and Chemotherapy Drugs tested (with breakthrough times) are:
Chemotherapy Drug and Concentration Breakthrough Time (minutes)
Carmustine (BNCU) (3.3 mg/ml) 25.5
Cyclophosphamide (20.0 mg/ml) >240
Doxorubicin HCl (2.0 mg/ml) >240
Etoposide (20.0 mg/ml) >240
5-Fluorouracil (50.0 mg/ml) >240
Methotrexate (25.0 mg/ml) >240
Paclitaxel (6.0 mg/ml) >240
Thiotepa (10.0 mg/ml) 47.7
Vincristine Sulfate (1.0 mg/ml) >240
Fentanyl (100mcg/2ml) >240
CAUTION: Testing showed an average breakthrough time of 25.5 min for Carmustine and 47.7 min for Thiotepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220825 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220825: Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220825
Report an extraction error
Are you the manufacturer?
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