510(k) · Cleared
ClearedSANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanrea Healthcare Products Pvt, Ltd. · LYY Latex Patient Examination Glove
Cleared on Jan 26, 2018 as substantially equivalent to K052728 (M/S. Kanam Latex Industries Pvt., Ltd., 2005) after a 262-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.
- Decided
- Jan 26, 2018
- Review
- 262 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052728 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK052728 Powder Free Latex Sterile Patient Examination GlovesM/S. Kanam Latex Industries Pvt., Ltd. · 2005
- This deviceK171367 SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK…Sanrea Healthcare Products Pvt, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK223298 Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052728 | Powder Free Latex Sterile Patient Examination Gloves | M/S. Kanam Latex Industries Pvt., Ltd. | 2005 | — |
| 0 (this device) | K171367 | SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE… | Sanrea Healthcare Products Pvt, Ltd. | 2018 | — |
| +1 | K223298 | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) | Shandong Intco Medical Products Co, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K052728 | Powder Free Latex Sterile Patient Examination GlovesSummary page 5…F LEGALLY MARKETED PREDICATE DEVICE 5.1 Device Name : Powder free Latex Sterile Patient Examination Gloves 5.2 510(k) Number : K052728 5.3 Company : M/S. KANAM LATEX INDUSTRIES PVT. LTD. Ooppoottil… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223298 | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) | 2023 | 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?
- Its one ancestor has no recall.
- Of its descendants, K223298 (Shandong Intco Medical Products Co, Ltd., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LYY devicesLYY Latex Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LYY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYY
150in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYY
1in 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?
The Sterile Latex Patient Examination gloves, Powder Free, is a disposable device intended for medical purposes that is worn on the examiners’ hand or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171367: SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX 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/K171367
Report an extraction error
Are you the manufacturer?
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