510(k) · Cleared
ClearedEMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eco Medi Glove Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Sep 9, 2016 as substantially equivalent to K141982 (Wrp Asia Pacific Sdn. Bhd., 2015) after a 135-day review. Its family tree reaches back 3 generations to 2004. 8 later devices descend from it.
- Decided
- Sep 9, 2016
- Review
- 135 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042805 (2004). 4 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 2 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 1 generation backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- This deviceK161187 EMG Blue Nitrile Examination Gloves Powder Free with Tested for use…Eco Medi Glove Sdn. Bhd. · 2016
- Descendant · cites it directly · 3 of its ownK180452 White Nitrile Examination Glove, Sterile with Chemotherapy Drugs ClaimRiverstone Resources Sdn Bhd · 2018
- Descendant · cites it directly · 3 of its ownK171339 EMG Blue Nitrile Examination Gloves Powder free with tested for use…Eco Medi Glove Sdn. Bhd. · 2017
- Descendant · 2 generations on · 2 of its ownK190725 Nitrile Examination Glove Sterile Tested for use with Chemotherapy…Riverstone Resources Sdn Bhd · 2019
- Descendant · 2 generations on · 1 of its ownK212408 Powder Free Nitrile Examination Gloves (Tested for Use with…Pt. Maja Agung Latexindo · 2022
- Descendant · 3 generations on · 1 of its ownK220250 Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for…Grand Work Plastic Products Co., Ltd. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K180452White Nitrile Examination Glove, Sterile with Chemotherapy Drugs ClaimRiverstone Resources Sdn Bhd · 2018 · cites it directly3descendants
- K171339EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy…Eco Medi Glove Sdn. Bhd. · 2017 · cites it directly3descendants
- K190725Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, WhiteRiverstone Resources Sdn Bhd · 2019 · 2 generations on2descendants
- K212408Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and…Pt. Maja Agung Latexindo · 2022 · 2 generations on1descendant
- K220250Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy…Grand Work Plastic Products Co., Ltd. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −2 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −1 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| 0 (this device) | K161187 | EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with… | Eco Medi Glove Sdn. Bhd. | 2016 | — |
| +1 | K180452 | White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim | Riverstone Resources Sdn Bhd | 2018 | — |
| +1 | K171339 | EMG Blue Nitrile Examination Gloves Powder free with tested for use with… | Eco Medi Glove Sdn. Bhd. | 2017 | — |
| +2 | K190725 | Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs… | Riverstone Resources Sdn Bhd | 2019 | — |
| +2 | K212408 | Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs… | Pt. Maja Agung Latexindo | 2022 | — |
| +3 | K220250 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with… | Grand Work Plastic Products Co., Ltd. | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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 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 |
|---|---|---|---|
| * | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for…Summary page 6…es Powder Free with tested for use with Chemotherapy drugs,LZC, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.It is equivalent to K141982, Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non Sterile, Tested for use with Chemotherapy Drugs… | 2015 |
What descends from it? (8)
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 12 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K180452 (Riverstone Resources Sdn Bhd, 2018) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K141982.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 powder-free patient eaxmination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and for use with chemotherapy drugs.In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs. Chemotherapy Drugs and Concentration…
Read the full statement (160 words)
A powder-free patient eaxmination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and for use with chemotherapy drugs.In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Chemotherapy Drugs and Concentration Minimum Breakthrough Detection Time (Min), pg/cm*minute
1) Carmustine (BCNU)(3.3mg/ml) 1.3 minutes
2) Cyclophosphamide (20mg/ml) > 240 minutes
3) Cytarabine (100mg/ml) > 240 minutes
4) Doxorubicin Hydrochloride (2mg/ml) > 240 minutes
5) Etopside (20mg/ml) > 240 minutes
6) Fluorouracil (50mg/ml) > 240 minutes
7) Methorexate (25mg/ml) > 240 minutes
8) Paclitaxel (6mg/ml) > 240 minutes
9) Thiotepa (10mg/ml) 67.8 minutes
The Maximum testing time is 240 Minutes.Please Note that the following drugs have extremely low Permeation time, Carmustine (BCNU) (3.3mg/ml)-Minimum breakthrough detection time : 1.3 pg/cm*minute
Thiotepa (10mg/ml) -Minimum breakthrough detection time : 67.8 pg/cm*minute
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/K161187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161187: EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161187
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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