510(k) · Cleared
ClearedHalyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O&M Halyard, Inc. · LZC Medical Glove, Specialty
Cleared on Nov 8, 2019 as substantially equivalent to K180646 (Halyard Health, 2018) after a 184-day review. Its family tree reaches back 6 generations to 2004. 3 later devices descend from it.
- Decided
- Nov 8, 2019
- Review
- 184 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K042805 (2004). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 5 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 4 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 3 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- 2 generations backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- 1 generation backK180646 Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with…Halyard Health · 2018
- This deviceK191230 Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling…O&M Halyard, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK231938 Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis…O&M Halyard, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK243133 Nitrile Powder Free Examination Gloves with Low Dermatitis…Kl-Kepong Rubber Products Sdn. Bhd. · 2025
- Descendant · cites it directly · 0 of its ownK220541 PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA…O&M Halyard, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See all- K231938Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for…O&M Halyard, Inc. · 2024 · cites it directly1descendant
- K243133Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use…Kl-Kepong Rubber Products Sdn. Bhd. · 2025 · 2 generations on0descendants
- K220541PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free…O&M Halyard, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −5 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −4 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −3 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017 | — |
| −2 | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2017 | — |
| −1 | K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with… | Halyard Health | 2018 | — |
| 0 (this device) | K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG*… | O&M Halyard, Inc. | 2019 | — |
| +1 | K231938 | Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential… | O&M Halyard, Inc. | 2024 | — |
| +2 | K243133 | Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested… | Kl-Kepong Rubber Products Sdn. Bhd. | 2025 | — |
| +1 | K220541 | PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile… | O&M Halyard, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsSummary page 7…Product Code LZC and Classification Name Class I, 21 CFR §880.6250 Patient Examination Glove Predicate Device K180646 Halyard Lavender Nitrile Powder-Free Exam Gloves Subject Device Description Halyard Sterling S… | 2018 |
What descends from it? (3)
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 7 companies; a new generation was cleared every 2.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K231938 (O&M Halyard, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K180646.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Sterling Nitrile Powder-Free Exam Gloves are disposable devices intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs: Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes…
Read the full statement (1,036 words)
The Halyard Sterling Nitrile Powder-Free Exam Gloves are disposable devices intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs:
Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes
Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes
Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes
Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes
Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes
Paraplatin (10 mg/ml), No breakthrough up to 240 minutes
Bendamustine (5 mg/ml), No breakthrough up to 240 minutes
Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes
Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes
Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes
Etoposide (20 mg/ml), No breakthrough up to 240 minutes
Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes
Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes
Fludarabine (25 mg/ml), No breakthrough up to 240 minutes
Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes
Busulfan (6 mg/ml),No breakthrough up to 240 minutes
Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes,
Retrovir (10 mg/ml) No breakthrough up to 240 minutes
Carboplatin (10 mg/ml), No breakthrough up to 240 minutes
Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes
Rituximab (10 mg/ml), No breakthrough up to 240 minutes
Carfilzomib (2 mg/ml), No breakthrough up to 240 minutes
Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes
Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes
Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes
Idarubicin (1 mg/ml), No breakthrough up to 240 minutes
Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes
Cisplatin (1 mg/ml), No breakthrough up to 240 minutes
Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes
Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes
Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes
Irinotecan (20 mg/ml), No breakthrough up to 240 minutes
Triclosan (2 mg/ml), No breakthrough up to 240 minutes
Cytarabine HCL (100 mg/ml), No breakthrough up to 240 minutes
Mechlorethamine HCL (1 mg/ml), No breakthrough up to 240 minutes
Trisonex (1 mg/ml), No breakthrough up to 240 minutes
Cytovene (10 mg/ml), No breakthrough up to 240 minutes
Melphalan (5 mg/ml), No breakthrough up to 240 minutes
Vincrinstine Sulfate (1 mg/ml), No breakthrough up to 240 minutes
Dacarbazine (10 mg/ml), No breakthrough up to 240 minutes
Methotrexate (25 mg/ml), No breakthrough up to 240 minutes,
Vinblastine (1 mg/ml), No breakthrough up to 240 minutes
Daunorubicin HCL (5 mg/ml), No breakthrough up to 240 minutes
Mitomycin-C (0.5 mg/ml), No breakthrough up to 240 minutes
Vinorelbine (10 mg/ml), No breakthrough up to 240 minutes
Decitabine (5 mg/ml), No breakthrough up to 240 minutes
Mitoxantrone (2 mg/ml), No breakthrough up to 240 minutes
Zoledronic Acid (0.8 mg/ml),No breakthrough up to 240 minutes
Docetaxel (10 mg/ml), No breakthrough up to 240 minutes
Oxaliplatin (2 mg/ml), No breakthrough up to 240 minutes
ThioTEPA (10 mg/ml), breakthrough detected at 37.1 minutes
Carmustine (3.3 mg/ml), breakthrough detected at 22.9 minutes
The Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves are disposable devices intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs:
Arsenic Trioxide (1 mg/ml), No breakthrough up to 240 minutes
Doxorubicin HCL (2 mg/ml), No breakthrough up to 240 minutes
Paclitaxel (6 mg/ml), No breakthrough up to 240 minutes
Azacitidine (Vidaza) (25 mg/ml), No breakthrough up to 240 minutes
Epirubicin (Ellence) (2 mg/ml), No breakthrough up to 240 minutes
Paraplatin (10 mg/ml), No breakthrough up to 240 minutes
Bendamustine (5 mg/ml), No breakthrough up to 240 minutes
Eribulin Mesylate (0.5 mg/ml), No breakthrough up to 240 minutes
Pemetrexed (25 mg/ml), No breakthrough up to 240 minutes
Bortezomib (Velcade) (1 mg/ml), No breakthrough up to 240 minutes
Etoposide (20 mg/ml), No breakthrough up to 240 minutes
Pertuzumab (30 mg/ml), No breakthrough up to 240 minutes
Bleomycin sulfate (15 mg/ml), No breakthrough up to 240 minutes
Fludarabine (25 mg/ml), No breakthrough up to 240 minutes
Raltitrexed (0.5 mg/ml), No breakthrough up to 240 minutes
Busulfan (6 mg/ml),No breakthrough up to 240 minutes
Fluorouracil (50 mg/ml), No breakthrough up to 240 minutes
Retrovir (10 mg/ml) No breakthrough up to 240 minutes
Carboplatin (10 mg/ml), No breakthrough up to 240 minutes
Fulvestrant (50 mg/ml), No breakthrough up to 240 minutes
Rituximab (10 mg/ml), No breakthrough up to 240 minutes
Carfilzomib (2 mg/ml), No breakthrough up to 240 minutes
Gemcitabine (38 mg/ml), No breakthrough up to 240 minutes
Temsirolimus (25 mg/ml), No breakthrough up to 240 minutes
Cetuximab (Erbitux) (2 mg/ml), No breakthrough up to 240 minutes
Idarubicin (1 mg/ml), No breakthrough up to 240 minutes
Trastuzumab (21 mg/ml), No breakthrough up to 240 minutes
Cisplatin (1 mg/ml), No breakthrough up to 240 minutes
Ifosfamide (50 mg/ml), No breakthrough up to 240 minutes
Topotecan HCL (1 mg/ml), No breakthrough up to 240 minutes
Cyclophosphamide (20 mg/ml), No breakthrough up to 240 minutes
Irinotecan (20 mg/ml), No breakthrough up to 240 minutes
Triclosan (2 mg/ml), No breakthrough up to 240 minutes
Cytarabine HCL (100 mg/ml), No breakthrough up to 240 minutes
Mechlorethamine HCL (1 mg/ml), No breakthrough up to 240 minutes
Trisonex (1 mg/ml), No breakthrough up to 240 minutes
Cytovene (10 mg/ml), No breakthrough up to 240 minutes
Melphalan (5 mg/ml), No breakthrough up to 240 minutes
Vincrinstine Sulfate (1 mg/ml), No breakthrough up to 240 minutes
Dacarbazine (10 mg/ml), No breakthrough up to 240 minutes
Methotrexate (25 mg/ml), No breakthrough up to 240 minutes,
Vinblastine (1 mg/ml), No breakthrough up to 240 minutes
Daunorubicin HCL (5 mg/ml), No breakthrough up to 240 minutes
Mitomycin-C (0.5 mg/ml), No breakthrough up to 240 minutes
Vinorelbine (10 mg/ml), No breakthrough up to 240 minutes
Decitabine (5 mg/ml), No breakthrough up to 240 minutes
Mitoxantrone (2 mg/ml), No breakthrough up to 240 minutes
Zoledronic Acid (0.8 mg/ml),No breakthrough up to 240 minutes
Docetaxel (10 mg/ml), No breakthrough up to 240 minutes
Oxaliplatin (2 mg/ml), No breakthrough up to 240 minutes
ThioTEPA (10 mg/ml), breakthrough detected at 23.9 minutes
Carmustine (3.3 mg/ml), breakthrough detected at 14.8 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191230: Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191230
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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