510(k) Report

510(k) · Cleared

Cleared

Esteem Sterile Polyisoprene Surgical Gloves

K011721510(k) TraditionalCleared Aug 14, 200171-day reviewClass I21 CFR 878.4460

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Allegiance Healthcare Corp. · KGO Surgeon'S Gloves

Cleared on Aug 14, 2001 after a 71-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.

Decided
Aug 14, 2001
Review
71 days
Class
Class I
Product code
KGO
Recalls
None
Predicates
0

14 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2004: 1 descendant cleared2005: 1 descendant cleared2011: 2 descendants cleared2016: 2 descendants cleared2014: 1 descendant cleared2017: 3 descendants cleared2015: 1 descendant cleared2020: 1 descendant cleared200020052010201520202025
  1. This deviceK011721 Esteem Sterile Polyisoprene Surgical GlovesAllegiance Healthcare Corp. · 2001
  2. Descendant · cites it directly · 8 of its ownK093300 Esteem SMT Polyisoprene Powder-Free Surgical Sterile GlovesCardinal Health, Inc. · 2009
  3. Descendant · 2 generations on · 6 of its ownK110272 Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with…Cardinal Health, Inc. · 2011 · Recalled
  4. Descendant · 3 generations on · 2 of its ownK152428 SensiCare PI Surgical GlovesMedline Industries, Inc. · 2016
  5. Descendant · 3 generations on · 1 of its ownK140477 Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove…Molnlycke Health Care Us, LLC · 2015
  6. Descendant · cites it directly · 1 of its ownK092304 Esteem Ortho Polyisoprene Powder-Free Surgical GlovesCardinal Health, Inc. · 2009

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12009: 22011: 22014: 12015: 12016: 22017: 32020: 1
2004high 3 (2017) · low 0 (2006)2026

Most influential descendants

Showing 5 of 14 · See all
  • K093300Esteem SMT Polyisoprene Powder-Free Surgical Sterile GlovesCardinal Health, Inc. · 2009 · cites it directly8descendants
  • K110272Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy DrugCardinal Health, Inc. · 2011 · 2 generations on6descendants
  • K152428SensiCare PI Surgical GlovesMedline Industries, Inc. · 2016 · 3 generations on2descendants
  • K140477Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove SeriesMolnlycke Health Care Us, LLC · 2015 · 3 generations on1descendant
  • K092304Esteem Ortho Polyisoprene Powder-Free Surgical GlovesCardinal Health, Inc. · 2009 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011721Esteem Sterile Polyisoprene Surgical GlovesAllegiance Healthcare Corp.2001—
+1K093300Esteem SMT Polyisoprene Powder-Free Surgical Sterile GlovesCardinal Health, Inc.2009—
+2K110272Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with…Cardinal Health, Inc.20111
+3K152428SensiCare PI Surgical GlovesMedline Industries, Inc.2016—
+3K140477Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove SeriesMolnlycke Health Care Us, LLC2015—
+1K092304Esteem Ortho Polyisoprene Powder-Free Surgical GlovesCardinal Health, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200920
201120
201410
201510
201620
201730
202010
FIG. 1 — Lineage of K011721, 2001–2020Source: 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 KGO? 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 KGO device

  1. #1 K192328 JR.MEDIK Latex Surgeon’s Gloves Powder Freescore 15.2 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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
*—Duraprene Powder-Free Sterile Synthetic Surgical Gloves
Named without a submission number
—

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K093300Esteem SMT Polyisoprene Powder-Free Surgical Sterile GlovesCardinal Health, Inc.20098
K092304Esteem Ortho Polyisoprene Powder-Free Surgical GlovesCardinal Health, Inc.20091
K042574Esteem Blue Polyisoprene Surgical Gloves with Coating (Containing Chitosan, Provitamin…Cardinalhealth20041
K050181Medigloves Sterile Powder-Free Synthetic Polyisoprene Surgical GlovesMedigloves, Ltd.20050

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, K093300 (Cardinal Health, Inc., 2009) has gone furthest, with 8 descendants of its own.

How does its category compare?

All KGO devices

KGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGO

1in 2025

2007: 102008: 22009: 32010: 62011: 112012: 72013: 62014: 72015: 122016: 92017: 122018: 72019: 112020: 152021: 142022: 62023: 142024: 22025: 12026 (partial year): 2
2007high 15 (2020) · low 1 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGO

185in 2023

2007: 113 days median2009: 48 days median2010: 87 days median2011: 90 days median2012: 133 days median2013: 184 days median2014: 257 days median2015: 225 days median2016: 218 days median2017: 111 days median2018: 194 days median2019: 204 days median2020: 117 days median2021: 199 days median2022: 127 days median2023: 185 days median
2007high 257 (2014) · low 48 (2009)2026

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

Recalls per year · KGO

2in 2023

2009: 152010: 12016: 22017: 12018: 82022: 22023: 2
2007high 15 (2009) · low 0 (2007)2026

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

Adverse event reports per year · KGO

21in 2025

2007: 132008: 82009: 142010: 162011: 142012: 142013: 412014: 282015: 112016: 152017: 202018: 152019: 512020: 152021: 142022: 102023: 282024: 182025: 21
2007high 51 (2019) · low 8 (2008)2025

MAUDE reports naming product code KGO, 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
200710113013
20082—08
20093481514
2010687116
20111190014
20127133014
20136184041
20147257028
201512225011
20169218215
201712111120
20187194815
201911204051
202015117015
202114199014
20226127210
202314185228
20242—018
20251—021
20262—0—

What is it indicated for?

These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.

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

More from Allegiance Healthcare Corp.

63 FDA decisions under this applicant name. See the company

  • K023673Airlife Demand Nasal CannulaAllegiance Healthcare Corp. · 2003
  • K023419Trilaminate Drapes/TiburonAllegiance Healthcare Corp. · 2003
  • K024120Modification to Temno Biopsy NeedlesAllegiance Healthcare Corp. · 2003
  • K024292Modification to Positive Touch Powder-Free Latex Examination Gloves with Protein and Chemotherapy Labeling…Allegiance Healthcare Corp. · 2003
  • K024102Dental Powder-Free Latex Examination Gloves with Protein Labeling ClaimAllegiance Healthcare Corp. · 2002

Recent decisions in KGO

The KGO category page

  • K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder…Hartalega NGC Sdn. Bhd. · 2026
  • K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company Limited · 2026
  • K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs…Harps Europe Manufacturing GmbH · 2025
  • K240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd. · 2024
  • K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and…Wrp Asia Pacific Sdn. Bhd. · 2024

https://510kreport.com/device/K011721 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011721: Esteem Sterile Polyisoprene Surgical Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011721

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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