510(k) · Cleared

Cleared

Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs

K170686510(k) TraditionalCleared Jul 14, 2017129-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

Brightway Holdings Sdn. Bhd. · LZA Polymer Patient Examination Glove

Cleared on Jul 14, 2017 as substantially equivalent to K992162 (Safeskin Corp., 1999) after a 129-day review. Its family tree reaches back 1 generation to 1999. 4 later devices descend from it.

Decided: Jul 14, 2017
Review: 129 days
Class: Class I
Product code: LZA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K992162 (1999). 4 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK992162 Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with…Safeskin Corp. · 1999
This deviceK170686 Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with…Brightway Holdings Sdn. Bhd. · 2017
Descendant · cites it directly · 3 of its ownK200072 KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use…Kimberly-Clark Corporation · 2020
Descendant · 2 generations on · 0 of its ownK231435 KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for…Kimberly-Clark Corporation · 2023
Descendant · 2 generations on · 0 of its ownK231021 KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use…Kimberly-Clark Corporation · 2023
Descendant · 2 generations on · 0 of its ownK202416 Kimtech Prizm Multi-Layered Exam Glove Tested for use with…Kimberly Clark Corporation · 2020

Most influential descendants

Showing 4 of 4 · See all

K200072KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy…Kimberly-Clark Corporation · 2020 · cites it directly3descendants
K231435KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy…Kimberly-Clark Corporation · 2023 · 2 generations on0descendants
K231021KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy…Kimberly-Clark Corporation · 2023 · 2 generations on0descendants
K202416Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the…Kimberly Clark Corporation · 2020 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K992162	Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with…	Safeskin Corp.	1999	—
0 (this device)	K170686	Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with…	Brightway Holdings Sdn. Bhd.	2017	—
+1	K200072	KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with…	Kimberly-Clark Corporation	2020	—
+2	K231435	KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with…	Kimberly-Clark Corporation	2023	—
+2	K231021	KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with…	Kimberly-Clark Corporation	2023	—
+2	K202416	Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs…	Kimberly Clark Corporation	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	2	0
2023	2	0

FIG. 1 — Lineage of K170686, 1999–2023Source: 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 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
*	K992162	Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic… Summary page 5 …78-05 and meets all the requirements of ASTM D6319-10 and FDA 21 CFR 880.6250. Predicate device: Legally marked device to which substantial equivalence is claimed: 1) K992162 - Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim 5. Device Descriptio…	Safeskin Corp.	1999	—

Also cleared against K992162: 2 other devices →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K200072	KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy…	Kimberly-Clark Corporation	2020	3

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, K200072 (Kimberly-Clark Corporation, 2020) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K992162.

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. 2017, 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?

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs and their breakthrough detection times are as follows: Test Chemotherapy Drug Name and Concentration — Minimum Breakthrough Detection Time Blenoxane (15mg/ml), (15,000 ppm) — >240…

Read the full statement (295 words)

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Test Chemotherapy Drug Name and Concentration — Minimum Breakthrough Detection Time

Blenoxane (15mg/ml), (15,000 ppm) — >240 Minutes

Busulfan (6mg/ml), (6,000 ppm) — >240 Minutes

Carmustine (BCNU) (3.3mg/ml), (3,300 ppm) — 3.6 Minutes

Cisplatin (1.0mg/ml), (1,000 ppm) — >240 Minutes

Cyclophosphamide/Cytoxan (20mg/ml), (20,000 ppm) — >240 Minutes

Cytarabine (100mg/ml), (100,000 ppm) — >240 Minutes

Dacarbazine (DTIC) 10mg/ml, (10,000 ppm) — >240 Minutes

Daunorubicin (5mg/ml), (5,000 ppm) — >240 Minutes

Docetaxel (10mg/ml), (10,000 ppm) — >240 Minutes

Doxorubicin HCL (2mg/ml), (2,000 ppm) — >240 Minutes

Ellence (2mg/ml), (2,000 ppm) — >240 Minutes

Etoposide /Toposar (20mg/ml), (20,000 ppm) — >240 Minutes

Fludarabine (25mg/ml), (25,000 ppm) — >240 Minutes

Fluorouracil (50mg/ml), (50,000 ppm) — >240 Minutes

Gemcitabine (38mg/ml), (38,000 ppm) — >240 Minutes

Idarubicin (1.0mg/ml), (1,000 ppm) — >240 Minutes

Ifosfamide (50mg/ml), (50,000 ppm) — >240 Minutes

Irinotecan (20mg/ml), (20,000 ppm) — >240 Minutes

Mechlorethamine HCI (1.0mg/ml), (1,000 ppm) — >240 Minutes

Melphalan (5mg/ml), (5,000 ppm) — >240 Minutes

Methotrexate (25mg/ml), (25,000 ppm) — >240 Minutes

Mitomycin C (0.5 mg/ml), (500 ppm) — >240 Minutes

Mitoxantrone (2mg/ml), (2,000 ppm) — >240 Minutes

Paclitaxel (6.0mg/ml), (6,000 ppm) — >240 Minutes

Paraplatin (10mg/ml), (10,000 ppm) — >240 Minutes

Rituximab (10mg/ml), (10,000 ppm) — >240 Minutes

Thiotepa (10mg/ml), (10,000 ppm) — 15.9 Minutes

Trisenox (0.1mg/ml), (100 ppm) — >240 Minutes

Vincristine Sulfate (1.0mg/ml), (1,000 ppm) — >240 Minutes

Please note that Carmustine and Thiotepa have extremely low permeation times of 3.6 minutes and 15.9 minutes, respectively

WARNING: Do Not Use With: Carmustine, ThioTEPA

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/K170686 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170686: Nitrile Examination Gloves, Powder Free [Purple] 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/K170686

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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