510(k) Report

510(k) · Cleared

Cleared

Mcare PF Powder Free Latex Examination High Risk Gloves

K141042510(k) TraditionalCleared Mar 19, 2015330-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

Mercator Medical (Thailand), Ltd. · LYY Latex Patient Examination Glove

Cleared on Mar 19, 2015 after a 330-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.

Decided
Mar 19, 2015
Review
330 days
Class
Class I
Product code
LYY
Recalls
None
Predicates
0

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

Descendants, by year cleared 2019: 1 descendant cleared2020: 1 descendant cleared2025: 1 descendant cleared2022: 5 descendants cleared2021: 3 descendants cleared201620182020202220242026
  1. This deviceK141042 Mcare PF Powder Free Latex Examination High Risk GlovesMercator Medical (Thailand), Ltd. · 2015
  2. Descendant · cites it directly · 10 of its ownK192329 Blue Latex Examination Powder Free GlovesJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2019
  3. Descendant · 2 generations on · 4 of its ownK202377 Palm Care Latex Examination Powder Free GlovesHi-Care Thai Gloves Co., Ltd. · 2020
  4. Descendant · 2 generations on · 0 of its ownK250069 Powder Free Natural Rubber Latex Examination Gloves – Blue…Comfort Rubber Gloves Industries Sdn. Bhd. · 2025
  5. Descendant · 2 generations on · 0 of its ownK222348 JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022
  6. Descendant · 3 generations on · 0 of its ownK211601 Powder Free Latex Examination Glove, Non-SterileWrp Asia Pacific Sdn. Bhd. · 2022

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2019: 12020: 12021: 32022: 52025: 1
2019high 5 (2022) · low 0 (2023)2026

Most influential descendants

Showing 5 of 11 · See all
  • K192329Blue Latex Examination Powder Free GlovesJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2019 · cites it directly10descendants
  • K202377Palm Care Latex Examination Powder Free GlovesHi-Care Thai Gloves Co., Ltd. · 2020 · 2 generations on4descendants
  • K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein…Comfort Rubber Gloves Industries Sdn. Bhd. · 2025 · 2 generations on0descendants
  • K222348JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022 · 2 generations on0descendants
  • K211601Powder Free Latex Examination Glove, Non-SterileWrp Asia Pacific Sdn. Bhd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K141042Mcare PF Powder Free Latex Examination High Risk GlovesMercator Medical (Thailand), Ltd.2015—
+1K192329Blue Latex Examination Powder Free GlovesJr Engineering & Medical Technologies (M) Sdn. Bhd.2019—
+2K202377Palm Care Latex Examination Powder Free GlovesHi-Care Thai Gloves Co., Ltd.2020—
+2K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and…Comfort Rubber Gloves Industries Sdn. Bhd.2025—
+2K222348JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.2022—
+3K211601Powder Free Latex Examination Glove, Non-SterileWrp Asia Pacific Sdn. Bhd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202010
202130
202250
202510
FIG. 1 — Lineage of K141042, 2015–2025Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LYY? 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 LYY device

  1. #1 K202377 Palm Care Latex Examination Powder Free Glovesscore 12.7 · 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K192329Blue Latex Examination Powder Free GlovesJr Engineering & Medical Technologies (M) Sdn. Bhd.201910

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, K192329 (Jr Engineering & Medical Technologies (M) Sdn. Bhd., 2019) has gone furthest, with 10 descendants of its own.

How does its category compare?

All LYY devices

LYY Latex Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · LYY

1in 2025

2007: 122008: 132009: 72010: 132011: 112012: 112013: 62014: 32015: 32016: 42017: 42018: 22019: 12020: 12021: 82022: 142023: 22024: 12025: 1
2007high 14 (2022) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYY

150in 2022

2007: 75 days median2008: 151 days median2009: 76 days median2010: 106 days median2011: 127 days median2012: 133 days median2013: 131 days median2014: 156 days median2015: 251 days median2016: 142 days median2017: 230 days median2021: 188 days median2022: 150 days median
2007high 251 (2015) · low 75 (2007)2026

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

Recalls per year · LYY

1in 2020

2011: 12020: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · LYY

1in 2025

2007: 112008: 142009: 112010: 102011: 42012: 12013: 22014: 62015: 52016: 72017: 72019: 72020: 12021: 12024: 62025: 1
2007high 14 (2008) · low 0 (2018)2025

MAUDE reports naming product code LYY, 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
20071275011
200813151014
2009776011
201013106010
20111112714
20121113301
2013613102
2014315606
2015325105
2016414207
2017423007
20182—00
20191—07
20201—11
2021818801
20221415000
20232—00
20241—06
20251—01
20260—0—

What is it indicated for?

The mCare Powder Free Latex Examination Blue 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.

Indications for use as stated in the FDA 510(k) statement.

More from Mercator Medical (Thailand), Ltd.

7 FDA decisions under this applicant name. See the company

  • K251141Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy…Mercator Medical (Thailand), Ltd. · 2025
  • K213548Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with ChemotherapyMercator Medical (Thailand), Ltd. · 2022
  • K200967mCare (R) Powder Free Nitrile Orange Examination GlovesMercator Medical (Thailand), Ltd. · 2020
  • K192444mCare® Powder Free Nitrile Black Examination GloveMercator Medical (Thailand), Ltd. · 2019
  • K190876mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling ClaimedMercator Medical (Thailand), Ltd. · 2019

Recent decisions in LYY

The LYY category page

  • K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms…Comfort Rubber Gloves Industries Sdn. Bhd. · 2025
  • K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited · 2024
  • K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim…Kossan International Sdn Bhd · 2023
  • K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd. · 2023
  • K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2022

https://510kreport.com/device/K141042 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141042: Mcare PF Powder Free Latex Examination High Risk Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141042

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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