510(k) · Cleared
ClearedSHOWA (R) Blue Nitrile Powder Free Medical Examination Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Showa Best Glove, Inc. · LZA Polymer Patient Examination Glove
Cleared on Jan 19, 2022 as substantially equivalent to K200581 (Hartalega NGC Sdn. Bhd., 2020) after a 292-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Jan 19, 2022
- Review
- 292 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K200581 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backK200581 Biodegradable Nitrile Powder Free Examination Gloves Tested for Use…Hartalega NGC Sdn. Bhd. · 2020
- This deviceK211003 SHOWA (R) Blue Nitrile Powder Free Medical Examination GloveShowa Best Glove, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K200581 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with… | Hartalega NGC Sdn. Bhd. | 2020 | — |
| 0 (this device) | K211003 | SHOWA (R) Blue Nitrile Powder Free Medical Examination Glove | Showa Best Glove, Inc. | 2022 | — |
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 |
|---|---|---|---|
| * | K200581 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy…Summary page 6…Page 1 of 10 V. PREDICATE DEVICE Device Classification Name: Polymer Patient Examination Glove 510(k) Number: K200581 Product Code: LZA, LZC Applicant: Hartelega NGC SDN.BHD. Kawasan Perindustrian Tanjung… | 2020 |
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.
- 3 other devices also cite its predicate K200581.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 or fingers to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs. Chemotherapy Drug and concentration — Minimum Breakthrough, detection time in minutes: 1)…
Read the full statement (348 words)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hands or fingers to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.
Chemotherapy Drug and concentration — Minimum Breakthrough, detection time in minutes:
1) Blenoxane (15.0 mg/ml) 15,000 ppm — >240 minutes
2) Busulfan (6.0 mg/ml) 6,000 ppm — >240 minutes
3) Carboplatin (10.0 mg/ml) 10,000 ppm — >240 minutes
4) Carmustine (3.3 mg/ml) 3,300 ppm — 73.7 minutes
5) Cisplatin (1.0 mg/ml) 1,000 ppm — >240 minutes
6) Cyclophosphamide (20.0 mg/ml) 20,000 ppm — >240 minutes
7) Cytarabine (100.0 mg/ml) 100,000 ppm — >240 minutes
8) Dacarbazine (10.0 mg/ml) 10,000 ppm — >240 minutes
9) Daunorubicin HCl (5.0 mg/ml) 5,000 ppm — >240 minutes
10) Docetaxel (10.0 mg/ml) 10,000 ppm — >240 minutes
11) Doxorubicin HCl (2.0 mg/ml) 2,000 ppm — >240 minutes
12) Epirubicin HCl (2.0 mg/ml) 2,000 ppm — >240 minutes
13) Etoposide (20.0 mg/ml) 20,000 ppm — >240 minutes
14) Fludarabine (25.0 mg/ml) 25,000 ppm — >240 minutes
15) Fluorouracil (50.0 mg/ml) 50,000 ppm — >240 minutes
16) Gemcitabine (38.0 mg/ml) 38,000 ppm — >240 minutes
17) Idarubicin HCl (1.0 mg/ml) 1,000 ppm — >240 minutes
18) Ifosfamide (50.0 mg/ml) 50,000 ppm — >240 minutes
19) Irinotecan (20.0 mg/ml) 20,000 ppm — >240 minutes
20) Mechlorethamine HCl (1.0 mg/ml) 1,000 ppm — >240 minutes
21) Melphalan (5.0 mg/ml) 5,000 ppm — >240 minutes
22) Methotrexate (25.0 mg/ml) 25,000 ppm — >240 minutes
23) Mitomycin C (0.5 mg/ml) 500 ppm — >240 minutes
24) Mitoxantrone (2.0 mg/ml) 2,000 ppm — >240 minutes
25) Paclitaxel (6.0 mg/ml) 6,000 ppm — >240 minutes
26) Rituximab (10.0 mg/ml) 10,000 ppm — >240 minutes
27) ThioTepa (10.0 mg/ml) 10,000 ppm — 25.4 minutes
28) Trisenox (1.0 mg/ml) 1,000 ppm — >240 minutes
29) Vincristine Sulfate (1.0 mg/ml) 1,000 ppm — >240 minutes
The maximum testing time is 240 minutes. Warning: Do not use with Carmustine or ThioTepa.
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/K211003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211003: SHOWA (R) Blue Nitrile Powder Free Medical Examination Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211003
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