510(k) Report

510(k) · Cleared

Cleared

Powder Free Nitrile Examination Gloves, Blue

K102096510(k) TraditionalCleared Oct 4, 201069-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

Syntex Healthcare Products Co., Ltd. · LZA Polymer Patient Examination Glove

Cleared on Oct 4, 2010 as substantially equivalent to K093726 (Medline Industries, Inc., 2010) after a 69-day review. Its family tree reaches back 1 generation to 2010. 1 later device descends from it.

Decided
Oct 4, 2010
Review
69 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K093726 (2010). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2014: 1 descendant clearedK093726 · Mediguard Nitrile Examination Glove- Blue (Tested for Use with Chemotherapy Drugs) · Medline Industries, Inc. · 20102010201520202025
Descendants, by generation 1 generation forward: 1 descendant K093726 · Mediguard Nitrile Examination Glove- Blue (Tested for Use with Chemotherapy Drugs) · Medline Industries, Inc. · 20100
  1. Root · 1 generation backK093726 Mediguard Nitrile Examination Glove- Blue (Tested for Use with…Medline Industries, Inc. · 2010
  2. This deviceK102096 Powder Free Nitrile Examination Gloves, BlueSyntex Healthcare Products Co., Ltd. · 2010
  3. Descendant · cites it directly · 0 of its ownK140816 Powder Free Nitrile Examination Glove, Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K140816Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)Better Care Plastic Technology Co., Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K093726Mediguard Nitrile Examination Glove- Blue (Tested for Use with Chemotherapy…Medline Industries, Inc.2010—
0 (this device)K102096Powder Free Nitrile Examination Gloves, BlueSyntex Healthcare Products Co., Ltd.2010—
+1K140816Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs…Better Care Plastic Technology Co., Ltd.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K102096, 2010–2014Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K093726Mediguard Nitrile Examination Glove- Blue (Tested for Use with Chemotherapy Drugs)
Summary page 1
…lue) 3. Predicate Device Information: Medline Industries Incorporated Mediguard Powder Free Nitrile Examination Glove (Blue)- Tested for use with Chemotherapy (K093726) 4. Device Description: Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer P…
Medline Industries, Inc.2010—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K140816Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)Better Care Plastic Technology Co., Ltd.20140

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.
  • Of its descendants, K140816 (Better Care Plastic Technology Co., Ltd., 2014) has gone furthest, with 0 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. 2010, 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?

A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs and their breakthrough detection times are as follows: Chemotherapy Drug Average BDT Fluorouracil >240 min. Etoposide (Toposar) >240 min., Cyclophosphamide (Cytoxan) >240 min. Carmustine 2.03 min. Thiotepa 25.23 min. Paclitaxel (Taxol) >240 min.…

Read the full statement (91 words)

A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Chemotherapy Drug Average BDT

Fluorouracil >240 min.

Etoposide (Toposar) >240 min.,

Cyclophosphamide (Cytoxan) >240 min.

Carmustine 2.03 min.

Thiotepa 25.23 min.

Paclitaxel (Taxol) >240 min.

Doxorubicin Hydrochloride >240 min.

Dacarbazine (DTIC) >240 min.

Cisplatin >240 min.

Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes.

Indications for use as stated in the FDA summary.

More from Syntex Healthcare Products Co., Ltd.

17 FDA decisions under this applicant name. See the company

  • K240080Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl CitrateSyntex Healthcare Products Co., Ltd. · 2024
  • K231643Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl…Syntex Healthcare Products Co., Ltd. · 2023
  • K103770Same/Various Distributors/ WE May Private LabelSyntex Healthcare Products Co., Ltd. · 2011
  • K052877Powder Free Nitrile Blue Textured Examination GloveSyntex Healthcare Products Co., Ltd. · 2005
  • K042226Syntex Powder-Free Nitrile Examination Glove, Tested for ChemotherapySyntex Healthcare Products Co., Ltd. · 2004

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/K102096 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102096: Powder Free Nitrile Examination Gloves, Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102096

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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