510(k) · Cleared
ClearedEncore Mark IV Powder Free Polymer Coated Latex Surgical Glove with Protein Content Labeling Claim (50 Micrograms or LE)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ansell Perry · KGO Surgeon'S Gloves
Cleared on Dec 14, 1998 after a 70-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Dec 14, 1998
- Review
- 70 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK983489 Encore Mark IV Powder Free Polymer Coated Latex Surgical Glove with…Ansell Perry · 1998
- Descendant · cites it directly · 1 of its ownK202765 ENCORE Latex Textured Surgical Gloves, Powder Free with Protein…Careplus (M) Sdn Bhd · 2021
- Descendant · cites it directly · 1 of its ownK103714 Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for…Ansell Healthcare Products, LLC · 2011
- Descendant · 2 generations on · 0 of its ownK232444 Sterile Powder Free Latex Surgical Gloves, Tested for Use with…Grand Work Plastic Products Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK210724 ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein…Careplus (M) Sdn Bhd · 2021
Most influential descendants
Showing 4 of 4 · See all- K202765ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim…Careplus (M) Sdn Bhd · 2021 · cites it directly1descendant
- K103714Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with ChemotheraAnsell Healthcare Products, LLC · 2011 · cites it directly1descendant
- K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd. · 2023 · 2 generations on0descendants
- K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling…Careplus (M) Sdn Bhd · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983489 | Encore Mark IV Powder Free Polymer Coated Latex Surgical Glove with Protein… | Ansell Perry | 1998 | — |
| +1 | K202765 | ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content… | Careplus (M) Sdn Bhd | 2021 | — |
| +1 | K103714 | Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with… | Ansell Healthcare Products, LLC | 2011 | — |
| +2 | K232444 | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy… | Grand Work Plastic Products Co., Ltd. | 2023 | — |
| +2 | K210724 | ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content… | Careplus (M) Sdn Bhd | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2021 | 2 | 0 |
| 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 KGO? 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 KGO device
- #1 K192328 JR.MEDIK Latex Surgeon’s Gloves Powder Freescore 15.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K202765 (Careplus (M) Sdn Bhd, 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGO
185in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGO
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGO
21in 2025
MAUDE reports naming product code KGO, 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 | 10 | 113 | 0 | 13 |
| 2008 | 2 | — | 0 | 8 |
| 2009 | 3 | 48 | 15 | 14 |
| 2010 | 6 | 87 | 1 | 16 |
| 2011 | 11 | 90 | 0 | 14 |
| 2012 | 7 | 133 | 0 | 14 |
| 2013 | 6 | 184 | 0 | 41 |
| 2014 | 7 | 257 | 0 | 28 |
| 2015 | 12 | 225 | 0 | 11 |
| 2016 | 9 | 218 | 2 | 15 |
| 2017 | 12 | 111 | 1 | 20 |
| 2018 | 7 | 194 | 8 | 15 |
| 2019 | 11 | 204 | 0 | 51 |
| 2020 | 15 | 117 | 0 | 15 |
| 2021 | 14 | 199 | 0 | 14 |
| 2022 | 6 | 127 | 2 | 10 |
| 2023 | 14 | 185 | 2 | 28 |
| 2024 | 2 | — | 0 | 18 |
| 2025 | 1 | — | 0 | 21 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
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/K983489 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983489: Encore Mark IV Powder Free Polymer Coated Latex Surgical Glove with Protein Content Labeling Claim (50 Micrograms or LE).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983489
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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