510(k) · Cleared
ClearedRoyal Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shun Thai Rubber Gloves Industry Public Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on May 20, 2010 as substantially equivalent to K051333 (Shun Thai Rubber Gloves Industry Co., Ltd., 2005) after a 267-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- May 20, 2010
- Review
- 267 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051333 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK051333 Nitrile Examination Gloves, Powder FreeShun Thai Rubber Gloves Industry Co., Ltd. · 2005
- This deviceK092617 Royal GuardShun Thai Rubber Gloves Industry Public Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051333 | Nitrile Examination Gloves, Powder Free | Shun Thai Rubber Gloves Industry Co., Ltd. | 2005 | — |
| 0 (this device) | K092617 | Royal Guard | Shun Thai Rubber Gloves Industry Public Co., Ltd. | 2010 | — |
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 |
|---|---|---|---|
| * | K051333 | Nitrile Examination Gloves, Powder FreeSummary page 2…and FDA requirements. This device is therefore substantially equivalent to currently marketed devices. It is safe~and effective as the predicate device 510OK 05 1333 Powder-Free Nitrile Examination Glove. IS. Date Summary Prepared: July 10. 2009… | 2005 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K051333.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
This glove is disposable and intended For medical purpose that is worn 0n the examiner's hand to prevent contamination between patient and examiner, gloves use lor protection againsi chemotherapy drugs as below. Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes. Nitrile Powder Free Examination Glove Blune Green White *Carmustine (BCNU) 40.00 17.00 9.00 Cyclophosphannide (Cytoxan) > 240 > 240 > 240 Doxorubicin HCId(Adhriamycin) >240 >…
Read the full statement (148 words)
This glove is disposable and intended For medical purpose that is worn 0n the examiner's hand to prevent contamination between
patient and examiner, gloves use lor protection againsi chemotherapy drugs as below.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.
Nitrile Powder Free Examination Glove Blune Green White
*Carmustine (BCNU) 40.00 17.00 9.00
Cyclophosphannide (Cytoxan) > 240 > 240 > 240
Doxorubicin HCId(Adhriamycin) >240 > 240 > 240
Etoposide (Toposar) >240 > 240 > 240
Fluorouracil >240 >240 >240
Paclitaxel (Taxol) >240 > 240 > 240
*Thio-Tepa 177.00 63.00 48.00
('isplafin >240 > 240 >240
Dacarbazine (DTIC) >240 > 240 >240
Nitrile Powder Free Examination Glove(Blue)
*CAUTION: Testing showed average breakthrough time of 40.00minutes with Carmustine.
Nitrite Powder Free Examination Glove(Green)
*WARNING: DO NOT USE WITH CARMUTINE.
Nitrile Powder Free Examination Glove(White)
CAUTION: Testing showed average breakthrough time of 48.00minutes with Thio-Tepa.
WARNING: DO NOT USE WITH CARMUTINE.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092617 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092617: Royal Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092617
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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