510(k) · Cleared

Recalled · Class II · 2015

Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile,Tested for Use W/ Chemotherapy Drugs

K110979510(k) TraditionalCleared Oct 20, 2011196-day reviewClass I21 CFR 880.6250Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Advanced Medical Products Sdn Bhd · LZA Polymer Patient Examination Glove

Cleared on Oct 20, 2011 as substantially equivalent to K022904 (Wrp Asia Pacific Sdn. Bhd., 2002) after a 196-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it. It has been recalled once.

Decided: Oct 20, 2011
Review: 196 days
Class: Class I
Product code: LZA
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K022904 (2002). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK022904 Dermagrip-N/Multiple/WRP Asia Pacific SDN BHD Powder Free Nitrile…Wrp Asia Pacific Sdn. Bhd. · 2002
This deviceK110979 Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves…Advanced Medical Products Sdn Bhd · 2011
Descendant · cites it directly · 0 of its ownK132354 Powder Free Blude Nitrile Patient Examination Glove, Non-SterileAdvanced Health Products, Lot 60 & 61 · 2014

Most influential descendants

Showing 1 of 1 · See all

K132354Powder Free Blude Nitrile Patient Examination Glove, Non-SterileAdvanced Health Products, Lot 60 & 61 · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K022904	Dermagrip-N/Multiple/WRP Asia Pacific SDN BHD Powder Free Nitrile Examination…	Wrp Asia Pacific Sdn. Bhd.	2002	—
0 (this device)	K110979	Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves…	Advanced Medical Products Sdn Bhd	2011	—
+1	K132354	Powder Free Blude Nitrile Patient Examination Glove, Non-Sterile	Advanced Health Products, Lot 60 & 61	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K110979, 2002–2014Source: 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

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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
*	K022904	Dermagrip-N/Multiple/WRP Asia Pacific SDN BHD Powder Free Nitrile Examination Gloves… Summary page 1 …FR 880.6250 product code LZA) 3.0 Identification of The Legally Marketed Devices: Dermagrip Powder Free Blue Nitrile Examination Gloves 510(k) #: K022904 MDL: D36500 Regulatory Class I Product code: LZA 4.0 Description of The Device: Powder Free…	Wrp Asia Pacific Sdn. Bhd.	2002	—

Also cleared against K022904: 4 other devices →

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
K132354	Powder Free Blude Nitrile Patient Examination Glove, Non-Sterile	Advanced Health Products, Lot 60 & 61	2014	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 25, 2015	Class II	Z-0133-2016	Nonconforming Material/Component	Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K132354 (Advanced Health Products, Lot 60 & 61, 2014) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K022904.

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. 2011, this device’s year, is highlighted.

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 examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110979 · printed Nov 4, 2026

Cite this page

510(k) Report. “K110979: Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile,Tested for Use W/ Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110979

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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