510(k) Report

510(k) · Cleared

Cleared

Nitrile Patient Examination Glove (Blue Color) Powder Free, Non Sterile

K000323510(k) TraditionalCleared Apr 5, 200063-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 Apr 5, 2000 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 101 later devices descend from it.

Decided
Apr 5, 2000
Review
63 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2007: 1 descendant cleared2008: 1 descendant cleared2016: 2 descendants cleared2009: 3 descendants cleared2012: 5 descendants cleared2017: 10 descendants cleared2019: 6 descendants cleared2018: 4 descendants cleared2010: 2 descendants cleared2013: 2 descendants cleared2011: 2 descendants cleared2015: 2 descendants cleared2023: 14 descendants cleared2020: 10 descendants cleared2022: 3 descendants cleared2014: 4 descendants cleared2021: 9 descendants cleared2024: 8 descendants cleared2026: 8 descendants cleared2025: 4 descendants cleared200020052010201520202025
  1. This deviceK000323 Nitrile Patient Examination Glove (Blue Color) Powder Free, Non…Siam Sempermed Corp., Ltd. · 2000
  2. Descendant · cites it directly · 100 of its ownK060753 Non-Sterile, Powder Free Nitrile Examination Glove, Blue with…Siam Sempermed Corp., Ltd. · 2006
  3. Descendant · 2 generations on · 97 of its ownK080520 Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer…Siam Sempermed Corp., Ltd. · 2008
  4. Descendant · 3 generations on · 78 of its ownK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
  5. Descendant · 4 generations on · 77 of its ownK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
  6. Descendant · 5 generations on · 75 of its ownK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled

Showing 5 of 101 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12008: 12009: 32010: 22011: 22012: 52013: 22014: 42015: 22016: 22017: 102018: 42019: 62020: 102021: 92022: 32023: 142024: 82025: 42026: 8
2006high 14 (2023) · low 1 (2006)2026

Most influential descendants

Showing 5 of 101 · See all
  • K060753Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating, Model…Siam Sempermed Corp., Ltd. · 2006 · cites it directly100descendants
  • K080520Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with…Siam Sempermed Corp., Ltd. · 2008 · 2 generations on97descendants
  • K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009 · 3 generations on78descendants
  • K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009 · 4 generations on77descendants
  • K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · 5 generations on75descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000323Nitrile Patient Examination Glove (Blue Color) Powder Free, Non SterileSiam Sempermed Corp., Ltd.2000—
+1K060753Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating…Siam Sempermed Corp., Ltd.2006—
+2K080520Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with…Siam Sempermed Corp., Ltd.2008—
+3K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.2009—
+4K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.2009—
+5K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.20101

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200810
200930
201020
201120
201250
201320
201440
201520
201620
2017100
201840
201960
2020100
202190
202230
2023140
202480
202540
202680
FIG. 1 — Lineage of K000323, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (101)

See all 101

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

NumberDeviceApplicantDecidedDescendants
K060753Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating, Model…Siam Sempermed Corp., Ltd.2006100

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, K060753 (Siam Sempermed Corp., Ltd., 2006) has gone furthest, with 100 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.

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—

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
  • K082957Non-Sterile, Powder Free Nitrile Examination Glove, Blue Color, Polymer Coated, Tested with Chemotherapy DrugsSiam 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/K000323 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000323: Nitrile Patient Examination Glove (Blue Color) Powder Free, Non Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000323

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026