510(k) · Cleared
ClearedNitrile Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sage Products, Inc. · LZC Medical Glove, Specialty
Cleared on Aug 25, 1997 as substantially equivalent to K902696 (Moss Point Glove Co., 1990) and 1 other predicate after a 222-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Aug 25, 1997
- Review
- 222 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902696 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK902696 N-DEXMoss Point Glove Co. · 1990
- This deviceK970135 Nitrile GlovesSage Products, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902696 | N-DEX | Moss Point Glove Co. | 1990 | — |
| 0 (this device) | K970135 | Nitrile Gloves | Sage Products, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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? (5)
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 |
|---|---|---|---|
| * | K902696 | N-DEXSummary page 2…Best turer Products, Inc. Supply, Inc. or Delta Medical Systems Product Code Uni&mned_ N-110 UNT-100 8005 9005 9905 K Number Has not been | Could not Could not Cauld not K902696 K915086 assigned yet locate locate locate Address Crystal Lake, | San Diego, Norwood, Menlo, GA Menlo, GA Menlo, GA IL CA Mass or… | 1990 |
| * | K915086 | Hpi Brown Nitrile Sensi-Grip Surgical GlovesSummary page 2…er Products, Inc. Supply, Inc. or Delta Medical Systems Product Code Uni&mned_ N-110 UNT-100 8005 9005 9905 K Number Has not been | Could not Could not Cauld not K902696 K915086 assigned yet locate locate locate Address Crystal Lake, | San Diego, Norwood, Menlo, GA Menlo, GA Menlo, GA IL CA Mass or Duluth,… | 1992 |
| * | — | Safeskin Gloves Named without a submission number | |
| * | — | Nitrex Named without a submission number | |
| * | — | N-Dex 8005 Named without a submission number |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K902696.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 medical glove worn on the hand of a healthcare worker and similar personnel to prevent contamination between healthcare personnel and patient. In addition, this glove is worn for the protection of the wearer against exposure to chemotherapeutic agents.
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/K970135 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970135: Nitrile Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970135
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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