510(k) · Cleared

Cleared

Triflex (R) Orth Sterile Surgeon's Gloves, Modified

K903987510(k) TraditionalCleared Oct 11, 199049-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

Baxter Healthcare Corp · KGO Surgeon'S Gloves

Cleared on Oct 11, 1990 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Oct 11, 1990
Review: 49 days
Class: Class I
Product code: KGO
Recalls: None
Predicates: 0

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

This deviceK903987 Triflex (R) Orth Sterile Surgeon's Gloves, ModifiedBaxter Healthcare Corp · 1990
Descendant · cites it directly · 1 of its ownK151778 Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical…Cardinal Health 200, Inc. · 2016
Descendant · 2 generations on · 0 of its ownK160875 Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical…Cardinal Health, Inc. · 2016

Most influential descendants

Showing 2 of 2 · See all

K151778Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel…Cardinal Health 200, Inc. · 2016 · cites it directly1descendant
K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with…Cardinal Health, Inc. · 2016 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K903987	Triflex (R) Orth Sterile Surgeon's Gloves, Modified	Baxter Healthcare Corp	1990	—
+1	K151778	Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with…	Cardinal Health 200, Inc.	2016	—
+2	K160875	Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves…	Cardinal Health, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	2	0

FIG. 1 — Lineage of K903987, 1990–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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 K192328 JR.MEDIK Latex Surgeon’s Gloves Powder Freescore 15.2 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K151778	Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel…	Cardinal Health 200, Inc.	2016	1

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, K151778 (Cardinal Health 200, Inc., 2016) has gone furthest, with 1 descendant 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

2007high 15 (2020) · low 1 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGO

185in 2023

2007high 257 (2014) · low 48 (2009)2026

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

Recalls per year · KGO

2in 2023

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	10	113	0	13
2008	2	—	0	8
2009	3	48	15	14
2010	6	87	1	16
2011	11	90	0	14
2012	7	133	0	14
2013	6	184	0	41
2014	7	257	0	28
2015	12	225	0	11
2016	9	218	2	15
2017	12	111	1	20
2018	7	194	8	15
2019	11	204	0	51
2020	15	117	0	15
2021	14	199	0	14
2022	6	127	2	10
2023	14	185	2	28
2024	2	—	0	18
2025	1	—	0	21
2026	2	—	0	—

https://510kreport.com/device/K903987 · printed Nov 5, 2026

Cite this page

510(k) Report. “K903987: Triflex (R) Orth Sterile Surgeon's Gloves, Modified.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K903987

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026