510(k) · Cleared

Cleared

Powdered Brown Latex Surgical Gloves, Sterile with Expiration Date Labeling Claim & Protein Content Labeling Claim

K021119510(k) TraditionalCleared Jul 5, 200288-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

Wrp Asia Pacific Sdn. Bhd. · KGO Surgeon'S Gloves

Cleared on Jul 5, 2002 as substantially equivalent to K960416 (Wembley Rubber Products (M) Sdn Bhd, 1996) after an 88-day review. Its family tree reaches back 1 generation to 1996.

Decided: Jul 5, 2002
Review: 88 days
Class: Class I
Product code: KGO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K960416 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK960416 Comfit MicropticWembley Rubber Products (M) Sdn Bhd · 1996
This deviceK021119 Powdered Brown Latex Surgical Gloves, Sterile with Expiration Date…Wrp Asia Pacific Sdn. Bhd. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K960416	Comfit Microptic	Wembley Rubber Products (M) Sdn Bhd	1996	—
0 (this device)	K021119	Powdered Brown Latex Surgical Gloves, Sterile with Expiration Date Labeling…	Wrp Asia Pacific Sdn. Bhd.	2002	—

FIG. 1 — Lineage of K021119, 1996–2002Source: 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
*	K960416	Comfit Microptic Summary page 1 …ex Surgical Gloves, Sterile are substantially equivalent to Microptic, Brown Beaded Surgeon’s Gloves (Powdered, Hypoallergenic) submitted and cleared under 510(k) number K960416. The only difference in this submission is to include the Expiration Date Labeling Claim and Protein Content Labeling Claim with…	Wembley Rubber Products (M) Sdn Bhd	1996	—

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.

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?

The surgical glove is a device made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021119 · printed Nov 5, 2026

Cite this page

510(k) Report. “K021119: Powdered Brown Latex Surgical Gloves, Sterile with Expiration Date Labeling Claim & Protein Content Labeling Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021119

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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