510(k) · Cleared

Cleared

Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant

K222058510(k) TraditionalCleared Oct 22, 2022102-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 Oct 22, 2022 as substantially equivalent to K032942 (Wrp Asia Pacific Sdn. Bhd., 2003) after a 102-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.

Decided: Oct 22, 2022
Review: 102 days
Class: Class I
Product code: KGO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K032942 (2003). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK032942 Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves…Wrp Asia Pacific Sdn. Bhd. · 2003
This deviceK222058 Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use…Wrp Asia Pacific Sdn. Bhd. · 2022
Descendant · cites it directly · 0 of its ownK230578 Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested…Wrp Asia Pacific Sdn. Bhd. · 2023

Most influential descendants

Showing 1 of 1 · See all

K230578Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with…Wrp Asia Pacific Sdn. Bhd. · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K032942	Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves, Sterile	Wrp Asia Pacific Sdn. Bhd.	2003	—
0 (this device)	K222058	Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with…	Wrp Asia Pacific Sdn. Bhd.	2022	—
+1	K230578	Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use…	Wrp Asia Pacific Sdn. Bhd.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0

FIG. 1 — Lineage of K222058, 2003–2023Source: 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

Get a 510(k) Report

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
*	K032942	Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves, Sterile Summary page 5 …c Sdn. Bhd. Device name Powder Free Polymer Coated Polyisoprene Surgical Glove, Sterile 510(k) Number K032942 Regulatory Class I Product Code KGO 4.0 Reference Device:…	Wrp Asia Pacific Sdn. Bhd.	2003	—
†	K203030	Powder Free Nitrile Surgical Glove, Sterile, Tested for Use with Chemotherapy Drugs	Wrp Asia Pacific Sdn. Bhd.	2021	—

Also cleared against K032942: 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
K230578	Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with…	Wrp Asia Pacific Sdn. Bhd.	2023	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?

Its one ancestor has no recall.
Of its descendants, K230578 (Wrp Asia Pacific Sdn. Bhd., 2023) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K032942.

How does its category compare?

All KGO devices

KGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug Concentration Average…

Read the full statement (184 words)

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Chemotherapy Drug Concentration Average Breakthrough Detection Time (Minutes)

*Carmustine (BCNU) (3.3 mg/ml) 24.0

Cisplatin (1.0 mg/ml) > 240

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

Dacarbazine (10.0 mg/ml) > 240

Doxorubicin Hydrochloride (2.0 mg/ml) > 240

Etoposide (20.0 mg/ml) > 240

Fluorouracil (50.0 mg/ml) > 240

Ifosfamide (50.0 mg/ml) > 240

Methotrexate (25.0 mg/ml) > 240

Mitomycin C (0.5 mg/ml) > 240

Mitoxantrone (2.0 mg/ml) > 240

Paclitaxel (6.0 mg/ml) > 240

*ThioTepa (10.0 mg/ml) 23.1

Vincristine Sulfate (1.0 mg/ml) > 240

*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 24.0 minutes and Thiotepa: 23.1. Do not use with Carmustine and Thiotepa

Fentanyl Resistance Breakthrough Detection Time in Minutes

Fentanyl Citrate Injection (100mcg/2mL) No breakthrough up to 240 minutes

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

https://510kreport.com/device/K222058 · printed Nov 5, 2026

Cite this page

510(k) Report. “K222058: Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222058

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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