510(k) · Cleared

Cleared

Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemothera

K103714510(k) TraditionalCleared Jul 7, 2011198-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

Ansell Healthcare Products, LLC · KGO Surgeon'S Gloves

Cleared on Jul 7, 2011 as substantially equivalent to K983489 (Ansell Perry, 1998) and 1 other predicate after a 198-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.

Decided: Jul 7, 2011
Review: 198 days
Class: Class I
Product code: KGO
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K983489 (1998). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK983489 Encore Mark IV Powder Free Polymer Coated Latex Surgical Glove with…Ansell Perry · 1998
This deviceK103714 Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for…Ansell Healthcare Products, LLC · 2011
Descendant · cites it directly · 0 of its ownK210724 ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein…Careplus (M) Sdn Bhd · 2021

Most influential descendants

Showing 1 of 1 · See all

K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling…Careplus (M) Sdn Bhd · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K983489	Encore Mark IV Powder Free Polymer Coated Latex Surgical Glove with Protein…	Ansell Perry	1998	—
0 (this device)	K103714	Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with…	Ansell Healthcare Products, LLC	2011	—
+1	K210724	ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content…	Careplus (M) Sdn Bhd	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0

FIG. 1 — Lineage of K103714, 1998–2021Source: 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? (2)

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
*	K983489	Encore Mark IV Powder Free Polymer Coated Latex Surgical Glove with Protein Content… Summary page 1 …eted Devices to Which Equivalence is being Claimed: Device Name: Encore Mark IV Powder-Free Surgical Gloves 5 10O(k) Number: K983489 Device Name: Duraprene Sterile Synthetic Powder-Free Surgical Gloves w…	Ansell Perry	1998	—
*	K013302	Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with… Summary page 1 …Gloves with Tested for use with Chemotherapy Drugs Labeling Claim 5 10O(k) Number: K013302 5.0 Identification of the Device: Encore Acclaim® Sterile Powder-Free Latex Surgical Gloves, Tested for Use wit…	Allegiance Healthcare Corp.	2001	—

Also cleared against K983489: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K210724	ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling…	Careplus (M) Sdn Bhd	2021	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K210724 (Careplus (M) Sdn Bhd, 2021) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K983489.

How does its category compare?

All KGO devices

KGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

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 device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has been tested for use with chemotherapy drugs. Chemotherapy Drug Permeation (average breakthrough detection time in minutes) (ASTM D6978-05) Vincristine Sulfate (1.0mg/mL) >240 Carmustine (BiCNU) (3.3mg/mL) 1.5 Cyclophosphamide (Cytoxan)(20.0mg/mL) >240 Doxorubicin Hydrochloride (2.0mg/mL) >240 5-Fluorouracil…

Read the full statement (90 words)

A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has been tested for use with chemotherapy drugs.

Chemotherapy Drug Permeation

(average breakthrough detection time in minutes) (ASTM D6978-05)

Vincristine Sulfate (1.0mg/mL) >240

Carmustine (BiCNU) (3.3mg/mL) 1.5

Cyclophosphamide (Cytoxan)(20.0mg/mL) >240

Doxorubicin Hydrochloride (2.0mg/mL) >240

5-Fluorouracil (50.0mg/mL) >240

Methotrexate (25.0mg/mL) >240

Etoposide (Toposar) (20.0mg/mL) >240

Paclitaxel (Taxol)(6.0mg/mL) >240

ThioTEPA (10.0mg/mL) 15.26

Please note that Carmustine and ThioTEPA have extremely low permeation times of 1.5 and 15.26 minutes respectively.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103714 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103714: Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemothera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103714

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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