510(k) · Cleared

Cleared

Dermagrip-N/Multiple/WRP Asia Pacific SDN BHD Powder Free Nitrile Examination Gloves, Non-Sterile

K022904510(k) TraditionalCleared Oct 3, 200230-day reviewClass I21 CFR 880.6250

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. · LZA Polymer Patient Examination Glove

Cleared on Oct 3, 2002 after a 30-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.

Decided: Oct 3, 2002
Review: 30 days
Class: Class I
Product code: LZA
Recalls: None
Predicates: 0

11 later devices descend from it, 5 citing it directly.

This deviceK022904 Dermagrip-N/Multiple/WRP Asia Pacific SDN BHD Powder Free Nitrile…Wrp Asia Pacific Sdn. Bhd. · 2002
Descendant · cites it directly · 4 of its ownK133168 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2014
Descendant · 2 generations on · 1 of its ownK210755 Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)Meditech Gloves Sdn Bhd · 2021
Descendant · 2 generations on · 1 of its ownK192635 Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)Wrp Asia Pacific Sdn. Bhd. · 2020
Descendant · cites it directly · 1 of its ownK140418 Powder Free Blue Nitrile Patient Examination Gloves, Non-SterileWrp Rubber Products Sdn Bhd · 2014
Descendant · cites it directly · 1 of its ownK110979 Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves…Advanced Medical Products Sdn Bhd · 2011 · Recalled

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2002high 3 (2014) · low 0 (2003)2026

Most influential descendants

Showing 5 of 11 · See all

K133168Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-SterileWrp Asia Pacific Sdn. Bhd. · 2014 · cites it directly4descendants
K210755Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)Meditech Gloves Sdn Bhd · 2021 · 2 generations on1descendant
K192635Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)Wrp Asia Pacific Sdn. Bhd. · 2020 · 2 generations on1descendant
K140418Powder Free Blue Nitrile Patient Examination Gloves, Non-SterileWrp Rubber Products Sdn Bhd · 2014 · cites it directly1descendant
K110979Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile,Tested…Advanced Medical Products Sdn Bhd · 2011 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K022904	Dermagrip-N/Multiple/WRP Asia Pacific SDN BHD Powder Free Nitrile Examination…	Wrp Asia Pacific Sdn. Bhd.	2002	—
+1	K133168	Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile	Wrp Asia Pacific Sdn. Bhd.	2014	—
+2	K210755	Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)	Meditech Gloves Sdn Bhd	2021	—
+2	K192635	Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)	Wrp Asia Pacific Sdn. Bhd.	2020	—
+1	K140418	Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile	Wrp Rubber Products Sdn Bhd	2014	—
+1	K110979	Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves…	Advanced Medical Products Sdn Bhd	2011	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2011	1	0
2013	1	0
2014	3	0
2017	1	0
2020	1	0
2021	2	0
2022	1	0

FIG. 1 — Lineage of K022904, 2002–2022Source: 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 LZA? 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 LZA device

#1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 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
*	—	Class I patient examination gloves, SOLZA, powder free Named without a submission number			—

What descends from it? (11)

See all 11

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K133168	Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile	Wrp Asia Pacific Sdn. Bhd.	2014	4
K140418	Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile	Wrp Rubber Products Sdn Bhd	2014	1
K110979	Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile,Tested…	Advanced Medical Products Sdn Bhd	2011	1
K132484	Dermagrip Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile	Wrp Asia Pacific Sdn. Bhd.	2013	0
K023517	Dermagrip-P Powder Free Pink Nitrile Examination Gloves, Non-Sterile	Wrp Asia Pacific Sdn. Bhd.	2002	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?

Of its descendants, K133168 (Wrp Asia Pacific Sdn. Bhd., 2014) has gone furthest, with 4 descendants of its own.

How does its category compare?

All LZA devices

LZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZA

24in 2025

2007high 146 (2022) · low 18 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZA

110in 2025

2007high 212 (2019) · low 89 (2024)2026

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

Recalls per year · LZA

3so far in 2026, the most since 2007

2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZA

73in 2025

2007high 76 (2024) · low 2 (2008)2025

MAUDE reports naming product code LZA, 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	21	95	0	7
2008	18	97	0	2
2009	28	112	0	12
2010	31	97	0	12
2011	26	122	0	9
2012	33	110	0	11
2013	20	130	0	10
2014	27	197	0	8
2015	20	112	1	12
2016	30	171	1	25
2017	44	124	0	4
2018	22	178	0	3
2019	25	212	0	21
2020	30	101	0	4
2021	139	111	0	20
2022	146	111	0	19
2023	62	92	0	24
2024	30	89	0	76
2025	24	110	0	73
2026	15	103	3	—

What is it indicated for?

The Powder Free Blue Nitrile Examination Glove, Non Sterile is a disposable device and is made of synthetic rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022904 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022904: Dermagrip-N/Multiple/WRP Asia Pacific SDN BHD Powder Free Nitrile Examination Gloves, Non-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022904

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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