510(k) Report

510(k) · Cleared

Cleared

Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color, Polymer Coated, Tested with Chemotherapy Drugs

K082957510(k) AbbreviatedCleared May 29, 2009238-day reviewClass I21 CFR 880.6250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siam Sempermed Corp., Ltd. · LZA Polymer Patient Examination Glove

Cleared on May 29, 2009 after a 238-day review. The FDA summary names no predicate by number. 6 later devices descend from it.

Decided
May 29, 2009
Review
238 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2011: 1 descendant cleared2022: 1 descendant cleared2020: 1 descendant cleared2025: 1 descendant cleared2023: 1 descendant cleared20052010201520202025
  1. This deviceK082957 Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color…Siam Sempermed Corp., Ltd. · 2009
  2. Descendant · cites it directly · 5 of its ownK101822 Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for…Sgmp Co., Ltd. · 2010
  3. Descendant · 2 generations on · 4 of its ownK111248 Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue…Yty Industry (Manjung) Sdn Bhd · 2011
  4. Descendant · 3 generations on · 1 of its ownK211810 Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use…Pt. Shamrock Manufacturing Corpora · 2022
  5. Descendant · 3 generations on · 1 of its ownK193666 Powder-Free Blue Nitrile Examination Gloves (Tested for use with…Medline Industries, Inc. · 2020
  6. Descendant · 4 generations on · 0 of its ownK243796 GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile…Glove One, LLC · 2025

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12020: 12022: 12023: 12025: 1
2010high 1 (2010) · low 0 (2012)2026

Most influential descendants

Showing 5 of 6 · See all
  • K101822Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy…Sgmp Co., Ltd. · 2010 · cites it directly5descendants
  • K111248Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd · 2011 · 2 generations on4descendants
  • K211810Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy…Pt. Shamrock Manufacturing Corpora · 2022 · 3 generations on1descendant
  • K193666Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and…Medline Industries, Inc. · 2020 · 3 generations on1descendant
  • K243796GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with…Glove One, LLC · 2025 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K082957Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color, Polymer…Siam Sempermed Corp., Ltd.2009—
+1K101822Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with…Sgmp Co., Ltd.2010—
+2K111248Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd2011—
+3K211810Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with…Pt. Shamrock Manufacturing Corpora2022—
+3K193666Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy…Medline Industries, Inc.2020—
+4K243796GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use…Glove One, LLC2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
202010
202210
202310
202510
FIG. 1 — Lineage of K082957, 2009–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K101822Non-Sterile Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy…Sgmp Co., Ltd.20105

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, K101822 (Sgmp Co., Ltd., 2010) has gone furthest, with 5 descendants of its own.

How does its category compare?

All LZA devices

LZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · LZA

24in 2025

2007: 212008: 182009: 282010: 312011: 262012: 332013: 202014: 272015: 202016: 302017: 442018: 222019: 252020: 302021: 1392022: 1462023: 622024: 302025: 242026 (partial year): 15
2007high 146 (2022) · low 18 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZA

110in 2025

2007: 95 days median2008: 97 days median2009: 112 days median2010: 97 days median2011: 122 days median2012: 110 days median2013: 130 days median2014: 197 days median2015: 112 days median2016: 171 days median2017: 124 days median2018: 178 days median2019: 212 days median2020: 101 days median2021: 111 days median2022: 111 days median2023: 92 days median2024: 89 days median2025: 110 days median2026 (partial year): 103 days median
2007high 212 (2019) · low 89 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZA

3so far in 2026, the most since 2007

2015: 12016: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZA

73in 2025

2007: 72008: 22009: 122010: 122011: 92012: 112013: 102014: 82015: 122016: 252017: 42018: 32019: 212020: 42021: 202022: 192023: 242024: 762025: 73
2007high 76 (2024) · low 2 (2008)2025

MAUDE reports naming product code LZA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007219507
2008189702
200928112012
20103197012
20112612209
201233110011
201320130010
20142719708
201520112112
201630171125
20174412404
20182217803
201925212021
20203010104
2021139111020
2022146111019
20236292024
20243089076
202524110073
2026151033—

What is it indicated for?

Based upon 21 CFR Part 880.6250; "Patient examination glove"

A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner

Indications for use as stated in the FDA summary.

More from Siam Sempermed Corp., Ltd.

37 FDA decisions under this applicant name. See the company

  • K142685Nitrile Examination Gloves with Aloe & Vitamin E, Powder- FreeSiam Sempermed Corp., Ltd. · 2015
  • K121549Non-Sterile, Powder-Free Nitrile Examination Glove, BlueSiam Sempermed Corp., Ltd. · 2012
  • K122363Non-Sterile, Powder Free Nitrile Examination Gloves, BlueSiam Sempermed Corp., Ltd. · 2012
  • K100907Non-Sterile, Powder Free Latex Examination Gloves and Protein Claim (50 Micrograms or Less) Model: White…Siam Sempermed Corp., Ltd. · 2010
  • K083755Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color, Polymer Coated, Texted with…Siam Sempermed Corp., Ltd. · 2009

Recent decisions in LZA

The LZA category page

  • K262208Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for…Yty Industry (Manjung) Sdn Bhd · 2026
  • K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and…Maxter Healthcare, Inc. · 2026
  • K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination…Top Glove Sdn. Bhd. · 2026
  • K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl…Gmp Medicare Sdn. Bhd. · 2026
  • K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth · 2026

https://510kreport.com/device/K082957 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082957: Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color, Polymer Coated, Tested 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/K082957

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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