510(k) · Cleared

Cleared

Sensicare -C Synthetic Polyisoprene Powder-Free Surgical Gloves

K023236510(k) TraditionalCleared Nov 12, 200246-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

Cleared on Nov 12, 2002 as substantially equivalent to K002933 (Maxxim Medical, 2000) after a 46-day review. Its family tree reaches back 1 generation to 2000.

Decided: Nov 12, 2002
Review: 46 days
Class: Class I
Product code: KGO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002933 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK002933 Sterile Sensicare Synthetic Polyisoprene Powder-Free Surgical GlovesMaxxim Medical · 2000
This deviceK023236 Sensicare -C Synthetic Polyisoprene Powder-Free Surgical GlovesMaxxim Medical · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002933	Sterile Sensicare Synthetic Polyisoprene Powder-Free Surgical Gloves	Maxxim Medical	2000	—
0 (this device)	K023236	Sensicare -C Synthetic Polyisoprene Powder-Free Surgical Gloves	Maxxim Medical	2002	—

FIG. 1 — Lineage of K023236, 2000–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K002933	Sterile Sensicare Synthetic Polyisoprene Powder-Free Surgical Gloves Summary page 1 …ee Surgical Gloves are substantially equivalent to the SensiCareTMSynthetic Polyisoprene Powder-Free Surgical Gloves previously submitted and cleared under 510(k) number K002933. The only difference is that this submission is for the inclusion of colorants in the glove substrate. The safety and effectivene…	Maxxim Medical	2000	—

Also cleared against K002933: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K002933.

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	—

What is it indicated for?

A surgeon glove is a disposable device intended for medical purposes that is worn on the surgeon’s hand to prevent contamination between patient and surgeon.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023236 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023236: Sensicare -C Synthetic Polyisoprene Powder-Free 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/K023236

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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