510(k) Report

510(k) · Cleared

Cleared

Ultrafree Sterile Latex Powder-Free Surgical Gloves

K964474510(k) TraditionalCleared Mar 11, 1997124-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 Mar 11, 1997 after a 124-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.

Decided
Mar 11, 1997
Review
124 days
Class
Class I
Product code
KGO
Recalls
None
Predicates
0

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

Descendants, by year cleared 2012: 2 descendants cleared2014: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK964474 Ultrafree Sterile Latex Powder-Free Surgical GlovesAllegiance Healthcare Corp. · 1997
  2. Descendant · cites it directly · 5 of its ownK120934 Protexis Latex Basic Sterile Latex Powder-Free Surgical Glove with…Cardinal Health, Inc. · 2012
  3. Descendant · 2 generations on · 4 of its ownK121897 Protexis Latex Basic Sterile Powder-Free Surgical GlovesCardinal Health, Inc. · 2012
  4. Descendant · 3 generations on · 3 of its ownK140988 Powder Free Sterile Latex Surgical Glove, Yellow Color (Brand Name…Hebei Hongsen Plastics Technology Co, Ltd. · 2014
  5. Descendant · 4 generations on · 2 of its ownK171550 Sterile Latex Surgical Gloves, Powder FreeSanrea Healthcare Products Pvt, Ltd. · 2018
  6. Descendant · 5 generations on · 1 of its ownK211953 Disposable Sterilized Latex Surgical GlovesJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · 2022

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2012: 22014: 12018: 12022: 12023: 1
2012high 2 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 6 · See all
  • K120934Protexis Latex Basic Sterile Latex Powder-Free Surgical Glove with Protein Content Label…Cardinal Health, Inc. · 2012 · cites it directly5descendants
  • K121897Protexis Latex Basic Sterile Powder-Free Surgical GlovesCardinal Health, Inc. · 2012 · 2 generations on4descendants
  • K140988Powder Free Sterile Latex Surgical Glove, Yellow Color (Brand Name: Titanfine)Hebei Hongsen Plastics Technology Co, Ltd. · 2014 · 3 generations on3descendants
  • K171550Sterile Latex Surgical Gloves, Powder FreeSanrea Healthcare Products Pvt, Ltd. · 2018 · 4 generations on2descendants
  • K211953Disposable Sterilized Latex Surgical GlovesJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · 2022 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K964474Ultrafree Sterile Latex Powder-Free Surgical GlovesAllegiance Healthcare Corp.1997—
+1K120934Protexis Latex Basic Sterile Latex Powder-Free Surgical Glove with Protein…Cardinal Health, Inc.2012—
+2K121897Protexis Latex Basic Sterile Powder-Free Surgical GlovesCardinal Health, Inc.2012—
+3K140988Powder Free Sterile Latex Surgical Glove, Yellow Color (Brand Name: Titanfine)Hebei Hongsen Plastics Technology Co, Ltd.2014—
+4K171550Sterile Latex Surgical Gloves, Powder FreeSanrea Healthcare Products Pvt, Ltd.2018—
+5K211953Disposable Sterilized Latex Surgical GlovesJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201410
201810
202210
202310
FIG. 1 — Lineage of K964474, 1997–2023Source: 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
*—Triflex Sterile Latex Powder-Free Surgical Gloves
Named without a submission number
—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K120934Protexis Latex Basic Sterile Latex Powder-Free Surgical Glove with Protein Content Label…Cardinal Health, Inc.20125

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, K120934 (Cardinal Health, Inc., 2012) has gone furthest, with 5 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?

Ultrafree Sterile Latex Powder-Free Surgical Gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures and non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.

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/K964474 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964474: Ultrafree Sterile Latex Powder-Free Surgical Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964474

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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