510(k) Report

510(k) · Cleared

Cleared

Sempermed Surgeons' Gloves - Supreme

K981096510(k) TraditionalCleared Oct 29, 1998218-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

Semperit Technische Produkte Gesellshaft · KGO Surgeon'S Gloves

Cleared on Oct 29, 1998 after a 218-day review. The FDA summary names no predicate by number. 6 later devices descend from it.

Decided
Oct 29, 1998
Review
218 days
Class
Class I
Product code
KGO
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 3 descendants cleared2001: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK981096 Sempermed Surgeons' Gloves - SupremeSemperit Technische Produkte Gesellshaft · 1998
  2. Descendant · cites it directly · 2 of its ownK013560 Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9Semperit Technische Produkte Gesellshaft · 2002
  3. Descendant · 2 generations on · 1 of its ownK160781 Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons…Semperit Investments Asia Pte, Ltd. · 2017
  4. Descendant · 3 generations on · 0 of its ownK250313 Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color…Harps Europe Manufacturing GmbH · 2025
  5. Descendant · cites it directly · 0 of its ownK014112 Satari Latex Patient Examination Powdered Glove Single Side Polymer…Siam Sempermed Corp., Ltd. · 2002
  6. Descendant · cites it directly · 0 of its ownK014110 Satari Powdered Latex Examination Gloves with Protein Content…Siam Sempermed Corp., Ltd. · 2002

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2001: 12002: 32017: 12025: 1
2001high 3 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 6 · See all
  • K013560Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9Semperit Technische Produkte Gesellshaft · 2002 · cites it directly2descendants
  • K160781Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons GlovesSemperit Investments Asia Pte, Ltd. · 2017 · 2 generations on1descendant
  • K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With…Harps Europe Manufacturing GmbH · 2025 · 3 generations on0descendants
  • K014112Satari Latex Patient Examination Powdered Glove Single Side Polymer Coated, Non Sterile…Siam Sempermed Corp., Ltd. · 2002 · cites it directly0descendants
  • K014110Satari Powdered Latex Examination Gloves with Protein Content Labeling Claim (50…Siam Sempermed Corp., Ltd. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K981096Sempermed Surgeons' Gloves - SupremeSemperit Technische Produkte Gesellshaft1998—
+1K013560Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9Semperit Technische Produkte Gesellshaft2002—
+2K160781Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons GlovesSemperit Investments Asia Pte, Ltd.2017—
+3K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For…Harps Europe Manufacturing GmbH2025—
+1K014112Satari Latex Patient Examination Powdered Glove Single Side Polymer Coated…Siam Sempermed Corp., Ltd.2002—
+1K014110Satari Powdered Latex Examination Gloves with Protein Content Labeling Claim…Siam Sempermed Corp., Ltd.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200230
201710
202510
FIG. 1 — Lineage of K981096, 1998–2025Source: 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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K013560Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9Semperit Technische Produkte Gesellshaft20022
K014112Satari Latex Patient Examination Powdered Glove Single Side Polymer Coated, Non Sterile…Siam Sempermed Corp., Ltd.20020
K014110Satari Powdered Latex Examination Gloves with Protein Content Labeling Claim (50…Siam Sempermed Corp., Ltd.20020
K012819Sempermed Derma Plus, Sizes 5.5,6,6.5,7,7.5,8,8.5,9Semperit Technische Produkte Gesellshaft20010

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, K013560 (Semperit Technische Produkte Gesellshaft, 2002) has gone furthest, with 2 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?

This medical glove is worn on the hand of surgeons, nurses and similar personnel to prevent contamination between health care personnel and the patient.

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

More from Semperit Technische Produkte Gesellshaft

3 FDA decisions under this applicant name. See the company

  • K013560Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9Semperit Technische Produkte Gesellshaft · 2002
  • K012819Sempermed Derma Plus, Sizes 5.5,6,6.5,7,7.5,8,8.5,9Semperit Technische Produkte Gesellshaft · 2001

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/K981096 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981096: Sempermed Surgeons' Gloves - Supreme.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981096

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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