510(k) Report

510(k) · Cleared

Cleared

Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G)

K014134510(k) TraditionalCleared Jan 22, 200236-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

Supergrade Healthcare Products Sdn. Bhd. · FMC Patient Examination Glove

Cleared on Jan 22, 2002 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jan 22, 2002
Review
36 days
Class
Class I
Product code
FMC
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2021: 1 descendant cleared200020052010201520202025
  1. This deviceK014134 Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G)Supergrade Healthcare Products Sdn. Bhd. · 2002
  2. Descendant · cites it directly · 1 of its ownK020042 Hycare Latex Examination Glove, Powder FreeHycare Intl. Co., Ltd. · 2002
  3. Descendant · 2 generations on · 0 of its ownK211209 Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex…Hycare International Co., Ltd. · 2021
  4. Descendant · cites it directly · 0 of its ownK023577 Powder Free Latex Exam Gloves, Poly Coated Natural and/or Colored…Yty Industry (Manjung) Sdn Bhd · 2002

Most influential descendants

Showing 3 of 3 · See all
  • K020042Hycare Latex Examination Glove, Powder FreeHycare Intl. Co., Ltd. · 2002 · cites it directly1descendant
  • K211209Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination GlovesHycare International Co., Ltd. · 2021 · 2 generations on0descendants
  • K023577Powder Free Latex Exam Gloves, Poly Coated Natural and/or Colored, with Protein Labeling…Yty Industry (Manjung) Sdn Bhd · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K014134Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G)Supergrade Healthcare Products Sdn. Bhd.2002—
+1K020042Hycare Latex Examination Glove, Powder FreeHycare Intl. Co., Ltd.2002—
+2K211209Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination GlovesHycare International Co., Ltd.2021—
+1K023577Powder Free Latex Exam Gloves, Poly Coated Natural and/or Colored, with…Yty Industry (Manjung) Sdn Bhd2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
202110
FIG. 1 — Lineage of K014134, 2002–2021Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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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? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020042Hycare Latex Examination Glove, Powder FreeHycare Intl. Co., Ltd.20021
K023577Powder Free Latex Exam Gloves, Poly Coated Natural and/or Colored, with Protein Labeling…Yty Industry (Manjung) Sdn Bhd20020

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, K020042 (Hycare Intl. Co., Ltd., 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All FMC devices

FMC Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMC

FDA has decided no FMC device since 2007.

Median 510(k) review, days · FMC

Too few FMC 510(k)s in any year since 2007 to give a median.

Recalls per year · FMC

No recall names FMC since 2007.

Adverse event reports per year · FMC

1in 2025

2007: 92008: 52009: 32010: 72011: 12012: 22013: 32014: 72015: 412016: 3332017: 322019: 12020: 12021: 32025: 1
2007high 333 (2016) · low 0 (2018)2025

MAUDE reports naming product code FMC, 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
20070—09
20080—05
20090—03
20100—07
20110—01
20120—02
20130—03
20140—07
20150—041
20160—0333
20170—032
20180—00
20190—01
20200—01
20210—03
20220—00
20230—00
20240—00
20250—01
20260—0—

More from Supergrade Healthcare Products Sdn. Bhd.

3 FDA decisions under this applicant name. See the company

  • K934133Patient Examination Gloves (Powder Free Gloves)Supergrade Healthcare Products Sdn. Bhd. · 1994
  • K891232Patient Examination GlovesSupergrade Healthcare Products Sdn. Bhd. · 1989

Recent decisions in FMC

The FMC category page

  • K042618Laglove Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color)La Glove (M) Sdn. Bhd. · 2004
  • K992337Blossom Powder Free Latex Examination Gloves with Protein Content Labeling Claim 50 MCGM or Less of Total…Mexpo Intl., Inc. · 1999
  • K932405Nitrile Rubber Examination Gloves (Powered)Safeskin Corp. · 1994
  • K932404Nitrile Rubber Powder-Free Examination GloveSafeskin Corp. · 1994
  • K923175Surgical Instrument Kit, DisposableUlti-Med Intl., Inc. · 1993

https://510kreport.com/device/K014134 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014134: Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014134

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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