510(k) · Cleared
ClearedSafeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safeskin Corp. · LZC Medical Glove, Specialty
Cleared on Aug 30, 1999 after a 66-day review. The FDA summary names its predicate without a number. 20 later devices descend from it.
- Decided
- Aug 30, 1999
- Review
- 66 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 3 citing it directly.
- This deviceK992162 Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with…Safeskin Corp. · 1999
- Descendant · cites it directly · 11 of its ownK101596 Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy…Kimberly-Clark · 2010
- Descendant · cites it directly · 8 of its ownK102032 Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove…Kimberly-Clark Corp. · 2010
- Descendant · 2 generations on · 5 of its ownK113423 Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free…Kimberly-Clark Corp. · 2012
- Descendant · 2 generations on · 4 of its ownK200633 Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple…0 & M Halyard, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK170686 Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with…Brightway Holdings Sdn. Bhd. · 2017
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K101596Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and…Kimberly-Clark · 2010 · cites it directly11descendants
- K102032Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove)…Kimberly-Clark Corp. · 2010 · cites it directly8descendants
- K113423Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam GloveKimberly-Clark Corp. · 2012 · 2 generations on5descendants
- K200633Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile…0 & M Halyard, Inc. · 2020 · 2 generations on4descendants
- K170686Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy DrugsBrightway Holdings Sdn. Bhd. · 2017 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992162 | Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with… | Safeskin Corp. | 1999 | — |
| +1 | K101596 | Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and… | Kimberly-Clark | 2010 | — |
| +1 | K102032 | Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove… | Kimberly-Clark Corp. | 2010 | — |
| +2 | K113423 | Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove | Kimberly-Clark Corp. | 2012 | — |
| +2 | K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free… | 0 & M Halyard, Inc. | 2020 | — |
| +1 | K170686 | Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with… | Brightway Holdings Sdn. Bhd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | — | Safeskin blue Nitrile Examination Glove Named without a submission number |
What descends from it? (20)
See all 203 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101596 | Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and… | 2010 | 11 |
| K102032 | Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove)… | 2010 | 8 |
| K170686 | Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs | 2017 | 4 |
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?
- Of its descendants, K101596 (Kimberly-Clark, 2010) has gone furthest, with 11 descendants 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.
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 intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with 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/K992162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992162: Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992162
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