510(k) Report

510(k) · Cleared

Cleared

Polycoat Powdered Latex Examination Glove with Aloe Vera & Protein Content Labeling Claim (200 Micrograms or Less)

K013254510(k) TraditionalCleared Feb 4, 2002129-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

Top Quality Mfg., Inc. · LZA Polymer Patient Examination Glove

Cleared on Feb 4, 2002 as substantially equivalent to K004018 (Top Quality Mfg., Inc., 2001) after a 129-day review. Its family tree reaches back 1 generation to 2001.

Decided
Feb 4, 2002
Review
129 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K004018 (2001). No later device cites it as a predicate yet.

K004018 · Skingard Polycoat Glove · Top Quality Mfg., Inc. · 2001200020022004
K004018 · Skingard Polycoat Glove · Top Quality Mfg., Inc. · 20010
  1. Root · 1 generation backK004018 Skingard Polycoat GloveTop Quality Mfg., Inc. · 2001
  2. This deviceK013254 Polycoat Powdered Latex Examination Glove with Aloe Vera & Protein…Top Quality Mfg., Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K004018Skingard Polycoat GloveTop Quality Mfg., Inc.2001—
0 (this device)K013254Polycoat Powdered Latex Examination Glove with Aloe Vera & Protein Content…Top Quality Mfg., Inc.2002—
FIG. 1 — Lineage of K013254, 2001–2002Source: 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
*K004018Skingard Polycoat Glove
Summary page 1
…oses to be worn on the examiner’s hand or finger to prevent contamination between patient and examiner. Polycoat Glove with | Skingard Polycoat Aloe Vera Gloves 510(k) K004018 Testing Completed ASTM D5712-95 Same ASTM D3578-00 Same ASTM D6124 Same Intended Use Examination Same Glove Latex Same Packagi…
Top Quality Mfg., Inc.2001—

What descends from it?

No later submission names this one as a predicate yet.

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.

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—

What is it indicated for?

The Top Quality Skingard Polycoat Powdered Latex Examination Glove with Aloe Vera is intended for medical purposes to be womn on the examiner’s hand or finger to prevent contamination between patient and examiner.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Top Quality Mfg., Inc.

4 FDA decisions under this applicant name. See the company

  • K013821Silk Touch Powdered Latex Examination Glove with Protein Content Labeling Claim (200 Micrograms or Less)Top Quality Mfg., Inc. · 2002
  • K004018Skingard Polycoat GloveTop Quality Mfg., Inc. · 2001
  • K000050Top Quality Chlorinated-Powderfree Examination GlovesTop Quality Mfg., Inc. · 2000

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/K013254 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013254: Polycoat Powdered Latex Examination Glove with Aloe Vera & Protein Content Labeling Claim (200 Micrograms or Less).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013254

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026