510(k) · Cleared
ClearedSafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safesource Direct, LLC · LZA Polymer Patient Examination Glove
Cleared on Mar 19, 2025 as substantially equivalent to K222898 (Safesource Direct, LLC, 2022) after a 27-day review. Its family tree reaches back 7 generations to 2004.
- Decided
- Mar 19, 2025
- Review
- 27 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K042805 (2004). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 6 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 5 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 4 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- 3 generations backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- 2 generations backK201390 Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use…Medline Industires, Inc. · 2020
- 1 generation backK222898 SafeSource Direct Blue Powder-Free Nitrile Exam GlovesSafesource Direct, LLC · 2022
- This deviceK250502 SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF…Safesource Direct, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −6 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −5 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −4 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017 | — |
| −3 | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2017 | — |
| −2 | K201390 | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with… | Medline Industires, Inc. | 2020 | — |
| −1 | K222898 | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves | Safesource Direct, LLC | 2022 | — |
| 0 (this device) | K250502 | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series… | Safesource Direct, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (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 |
|---|---|---|---|
| * | K222898 | SafeSource Direct Blue Powder-Free Nitrile Exam GlovesSummary page 6…uivalence is claimed: Trade/Proprietary Name: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves Manufacturer: SafeSource Direct, LLC 510(k): K222898 Common/Usual Name: Non-Powdered Patient Examination Glove Classification Name: Polymer Patient Examination Glove,… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- None of the 8 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. 2025, 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 patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Cisplatin 1.0 mg/ml > 240 Minutes Cyclophosphamide…
Read the full statement (326 words)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes
Cisplatin 1.0 mg/ml > 240 Minutes
Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240 Minutes
Dacarbazine (DTIC) 10.0 mg/ml > 240 Minutes
Doxorubicin Hydrochloride 2.0 mg/ml > 240 Minutes
Etoposide (Toposar) 20.0 mg/ml > 240 Minutes
Fluorouracil 50.0 mg/ml 0.5 mg/ml > 240 Minutes
Methotrexate 25 mg/ml > 240 Minutes
Mitomycin C 0.5 mg/ml > 240 Minutes
Paclitaxel (Taxol) 6.0 mg/ml > 240 Minutes
Thio-Tepa 10.0 mg/ml 87.0 Minutes
Vincristine Sulfate (Oncovin) 1.0 mg/ml > 240 Minutes
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes
Thio-Tepa 10.0 mg/ml 87.0 Minutes
Warning: Not recommended for use with these drugs.
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Carmustine (BCNU) 3.3 mg/ml 22.5 Minutes
Cisplatin 1.0 mg/ml > 240 Minutes
Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240 Minutes
Dacarbazine (DTIC) 10.0 mg/ml > 240 Minutes
Doxorubicin Hydrochloride 2.0 mg/ml > 240 Minutes
Etoposide (Toposar) 20.0 mg/ml > 240 Minutes
Fluorouracil 50.0 mg/ml 0.5 mg/ml > 240 Minutes
Methotrexate 25 mg/ml > 240 Minutes
Mitomycin C 0.5 mg/ml > 240 Minutes
Paclitaxel (Taxol) 6.0 mg/ml > 240 Minutes
Thio-Tepa 10.0 mg/ml 37.5 Minutes
Vincristine Sulfate (Oncovin) 1.0 mg/ml > 240 Minutes
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 22.5 Minutes
Thio-Tepa 10.0 mg/ml 37.5 Minutes
Warning: Not recommended for use with these drugs.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250502 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250502: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250502
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