510(k) Report

510(k) · Cleared

Cleared

Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex Examination Glove Made From Allotex an Enzyme Treated Natural

K021007510(k) TraditionalCleared Jul 5, 200299-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

Tillotson Healthcare Corp. · LYY Latex Patient Examination Glove

Cleared on Jul 5, 2002 as substantially equivalent to K002718 (Tillotson Healthcare Corp., 2001) and 2 other predicates after a 99-day review. Its family tree reaches back 3 generations to 1991.

Decided
Jul 5, 2002
Review
99 days
Class
Class I
Product code
LYY
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K910383 (1991). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 2 other ancestors1999: 1 other ancestor1998: 1 other ancestorK910383 · Hpi Sensi-Shield Glove Kit · Hpi, Inc. · 1991K960247 · Ultra Care Powder Free Hypoallergenic Patient Examination Glove · Tillotson Healthcare Corp. · 1996K982505 · Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex Patient Examination Glove · Tillotson Healthcare Corp. · 199919901992199419961998200020022004
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor K982505 · Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex Patient Examination Glove · Tillotson Healthcare Corp. · 1999K960247 · Ultra Care Powder Free Hypoallergenic Patient Examination Glove · Tillotson Healthcare Corp. · 1996K910383 · Hpi Sensi-Shield Glove Kit · Hpi, Inc. · 19910
  1. Root · 3 generations backK910383 Hpi Sensi-Shield Glove KitHpi, Inc. · 1991
  2. 2 generations backK960247 Ultra Care Powder Free Hypoallergenic Patient Examination GloveTillotson Healthcare Corp. · 1996
  3. 1 generation backK982505 Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex…Tillotson Healthcare Corp. · 1999
  4. This deviceK021007 Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex…Tillotson Healthcare Corp. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K910383Hpi Sensi-Shield Glove KitHpi, Inc.1991—
−2K960247Ultra Care Powder Free Hypoallergenic Patient Examination GloveTillotson Healthcare Corp.1996—
−1K982505Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex Patient…Tillotson Healthcare Corp.1999—
0 (this device)K021007Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex Examination Glove…Tillotson Healthcare Corp.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200120
FIG. 1 — Lineage of K021007, 1991–2002Source: 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 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 12.8 · 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? (3)

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
*K002718Ultra Care 2 Latex Examination Gloves Made From Allotex (Enzyme Treated) Natural Rubber…
Summary page 1
…Protein Content Claim of 200 micrograms or less with 15 milligrams o r less of Total Particulate per Glove. (K002718) b. Ultra Care (GREEN) Natural Rubber Latex Examination Gloves (K98…
Tillotson Healthcare Corp.2001—
*K982505Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex Patient Examination Glove
Summary page 1
…ss of Total Particulate per Glove. (K002718) b. Ultra Care (GREEN) Natural Rubber Latex Examination Gloves (K982505) c CymunVera Powder Free GREEN Natural Rubber Latex Exmination Glov…
Tillotson Healthcare Corp.1999—
*K013286Cymunvera Powder Free Green Natural Rubber Latex Patient Examination Glove Lined with…
Summary page 1
…Gloves (K982505) c CymunVera Powder Free GREEN Natural Rubber Latex Exmination Gloves Lined with ALOE VERA (K013286) 4. DESCRIPTION OF DEVICE HOW THE DEVICE FUNCTIONS: Natural Rubber Latex films form a barrier to body fluid…
Tillotson Healthcare Corp.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?

  • The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
  • None of the 7 ancestors has a recall.

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.

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 Ultra Preserve With Aloe Vera (Green) Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.".

Indications for use as stated in the FDA summary.

More from Tillotson Healthcare Corp.

20 FDA decisions under this applicant name. See the company

  • K013324Hpi Sensi Grip Sterile Powdered Latex Surgical Glove,with Labeled Protein Content and Made From Allotex an…Tillotson Healthcare Corp. · 2001
  • K013016True Advantage Non-Sterile Powder Free Purple Nitrile Examination GloveTillotson Healthcare Corp. · 2001
  • K013286Cymunvera Powder Free Green Natural Rubber Latex Patient Examination Glove Lined with Aloe VeraTillotson Healthcare Corp. · 2001
  • K011497Cymun-NBR Powder Free Blue Nitrile Examination GloveTillotson Healthcare Corp. · 2001
  • K002718Ultra Care 2 Latex Examination Gloves Made From Allotex (Enzyme Treated) Natural Rubber Latex with a Protein…Tillotson Healthcare Corp. · 2001

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/K021007 · printed Nov 3, 2026

Cite this page

510(k) Report. “K021007: Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex Examination Glove Made From Allotex an Enzyme Treated Natural.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021007

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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