510(k) · Cleared

Cleared

Powder Free Plus Hypoallergenic (with Labeled Protein Content) Patient Examination Gloves

K960225510(k) TraditionalCleared Jul 29, 1996194-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

Tillotson Healthcare Corp. · LYY Latex Patient Examination Glove

Cleared on Jul 29, 1996 as substantially equivalent to K954855 (Tillotson Healthcare Corp., 1995) and 1 other predicate after a 194-day review. Its family tree reaches back 1 generation to 1991.

Decided: Jul 29, 1996
Review: 194 days
Class: Class I
Product code: LYY
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K910383 (1991). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK910383 Hpi Sensi-Shield Glove KitHpi, Inc. · 1991
This deviceK960225 Powder Free Plus Hypoallergenic (with Labeled Protein Content)…Tillotson Healthcare Corp. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K910383	Hpi Sensi-Shield Glove Kit	Hpi, Inc.	1991	—
0 (this device)	K960225	Powder Free Plus Hypoallergenic (with Labeled Protein Content) Patient…	Tillotson Healthcare Corp.	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

FIG. 1 — Lineage of K960225, 1991–1996Source: 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 LYY? 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 LYY device

#1 K202377 Palm Care Latex Examination Powder Free Glovesscore 12.7 · 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? (2)

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
*	K954855	Powder Free Plus Patient Examination Glove Summary page 1 …ve CLASSIFICATION NAME Patient Examination Glove 3. PREDICATE DEVICE IDENTIFICATION NAME, NUMBER 1. POWDER FREE PLUS PATIENT EXAM GLOVE (WITH LABELED PROTEIN CONTENT), K954855, SE 12/28/85 2. CUT RESISTANT GLOVE KIT WITH HYPOALLERGENIC INNER GLOVE #KK910383 4, DESCRIPTION OF DEVICE Patient examination…	Tillotson Healthcare Corp.	1995	—
*	K910383	Hpi Sensi-Shield Glove Kit Summary page 1 …N NAME, NUMBER 1. POWDER FREE PLUS PATIENT EXAM GLOVE (WITH LABELED PROTEIN CONTENT), K954855, SE 12/28/85 2. CUT RESISTANT GLOVE KIT WITH HYPOALLERGENIC INNER GLOVE #KK910383 4, DESCRIPTION OF DEVICE Patient examination gioves are made with intact natural latex rubber film, which provides a barrier to…	Hpi, Inc.	1991	—

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?

None of the 2 ancestors has a recall.

How does its category compare?

All LYY devices

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

FDA decisions per year · LYY

1in 2025

2007high 14 (2022) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYY

150in 2022

2007high 251 (2015) · low 75 (2007)2026

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

Recalls per year · LYY

1in 2020

2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · LYY

1in 2025

2007high 14 (2008) · low 0 (2018)2025

MAUDE reports naming product code LYY, 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	12	75	0	11
2008	13	151	0	14
2009	7	76	0	11
2010	13	106	0	10
2011	11	127	1	4
2012	11	133	0	1
2013	6	131	0	2
2014	3	156	0	6
2015	3	251	0	5
2016	4	142	0	7
2017	4	230	0	7
2018	2	—	0	0
2019	1	—	0	7
2020	1	—	1	1
2021	8	188	0	1
2022	14	150	0	0
2023	2	—	0	0
2024	1	—	0	6
2025	1	—	0	1
2026	0	—	0	—

What is it indicated for?

This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves with labeled protein content are suitable in situations where health care worker or patient allergic sensitivity may be a factor, Powder free gloves are intended for use in situations where powder should not be used. Hypoallergenic gloves are appropriate for users who may have a previous sensitivity.

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/K960225 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960225: Powder Free Plus Hypoallergenic (with Labeled Protein Content) Patient Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960225

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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