510(k) · Cleared

Cleared

Powder Free Nitrile Patient Examination Glove,Blue and Orange Colored,Non-Sterile Tested for Use with Chemotherapy Drugs

K133949510(k) TraditionalCleared Apr 8, 2014106-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

Top Calibre Sdn Bhd · LZA Polymer Patient Examination Glove

Cleared on Apr 8, 2014 as substantially equivalent to K091652 (Hartalega Sdn Bhd, 2009) after a 106-day review. Its family tree reaches back 1 generation to 2009.

Decided: Apr 8, 2014
Review: 106 days
Class: Class I
Product code: LZA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K091652 (2009). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK091652 Nitrile Powder Fre Examination Gloves (Blue) Tested for Use with…Hartalega Sdn Bhd · 2009
This deviceK133949 Powder Free Nitrile Patient Examination Glove,Blue and Orange…Top Calibre Sdn Bhd · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K091652	Nitrile Powder Fre Examination Gloves (Blue) Tested for Use with Chemothreapy…	Hartalega Sdn Bhd	2009	—
0 (this device)	K133949	Powder Free Nitrile Patient Examination Glove,Blue and Orange…	Top Calibre Sdn Bhd	2014	—

FIG. 1 — Lineage of K133949, 2009–2014Source: 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
*	K091652	Nitrile Powder Fre Examination Gloves (Blue) Tested for Use with Chemothreapy Drugs Summary page 1 …C, meets all of the requirements of ASTM D 63 19-10 Standard Specification for Nitrile Examination Gloves for Medical Application. Predicate Device: K091652, Nitrile Powder Free Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs-VBLU…	Hartalega Sdn Bhd	2009	—

Also cleared against K091652: 1 other device →

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.
1 other device also cites its predicate K091652.

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. 2014, 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?

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below. Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time In Minutes) Carmustine (BCNU) (3.3 mg/ml) — 15.1 Cisplatin (1.0 mg/ml) — > 240 Cyclophosphamide (Cytoxan) (20 mg/ml) — > 240 Cytarabine…

Read the full statement (320 words)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

This glove has been tested for use with specific chemotherapy drugs listed below.

Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time In Minutes)

Carmustine (BCNU) (3.3 mg/ml) — 15.1

Cisplatin (1.0 mg/ml) — > 240

Cyclophosphamide (Cytoxan) (20 mg/ml) — > 240

Cytarabine (100 mg/ml) — > 240

Dacarbazine (DTIC) (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 mg/ml) — > 240

Mitomycin C (0.5 mg/ml) — > 240

Mitoxantrone (2.0 mg/ml) — > 240

Paclitaxel (Taxol) (6.0 mg/ml) — > 240

Thiotepa (10.0 mg/ml) — > 240

Vincristine Sulfate (1.0 mg/ml) — > 240

Please note that the following drug - Carmustine has extremely short permeation times of 15.1 minutes.

A patient examination glove is a disposable device intended for medical purposes that is worn on the examinees hand to prevent contamination between patient and examiner.

This glove has been tested for use with specific chemotherapy drugs listed below.

Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time In Minutes)

Carmustine (BCNU) (3.3 mg/ml) — 27.9

Cisplatin (1.0 mg/ml) — > 240

Cyclophosphamide (Cytoxan) (20 mg/ml) — > 240

Cytarabine (100 mg/ml) — > 240

Dacarbazine (DTIC) (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 mg/ml) — > 240

Mitomycin C (0.5 mg/ml) — > 240

Mitoxantrone (2.0 mg/ml) — > 240

Paclitaxel (Taxol) (6.0 mg/ml) — > 240

Thiotepa (10.0 mg/ml) — > 240

Vincristine Sulfate (1.0 mg/ml) — > 240

Please note that the following drug - Carmustine has extremely short permeation times of 17.9 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/K133949 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133949: Powder Free Nitrile Patient Examination Glove,Blue and Orange Colored,Non-Sterile Tested for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133949

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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