510(k) · Cleared
ClearedENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Careplus (M) Sdn Bhd · KGO Surgeon'S Gloves
Cleared on May 27, 2021 as substantially equivalent to K983489 (Ansell Perry, 1998) after a 248-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- May 27, 2021
- Review
- 248 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983489 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK983489 Encore Mark IV Powder Free Polymer Coated Latex Surgical Glove with…Ansell Perry · 1998
- This deviceK202765 ENCORE Latex Textured Surgical Gloves, Powder Free with Protein…Careplus (M) Sdn Bhd · 2021
- Descendant · cites it directly · 0 of its ownK232444 Sterile Powder Free Latex Surgical Gloves, Tested for Use with…Grand Work Plastic Products Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic 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 | K983489 | Encore Mark IV Powder Free Polymer Coated Latex Surgical Glove with Protein… | Ansell Perry | 1998 | — |
| 0 (this device) | K202765 | ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content… | Careplus (M) Sdn Bhd | 2021 | — |
| +1 | K232444 | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy… | Grand Work Plastic 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 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? (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 |
|---|---|---|---|
| * | K983489 | Encore Mark IV Powder Free Polymer Coated Latex Surgical Glove with Protein Content…Summary page 4…min. mm 0.10 Width, ± 6 mm 70 76 83 89 95 102 108 114 5.0 Predicate Device K983489, Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim), Ansell Perry. The device is a class I, Surgeon’s Gloves… | 1998 |
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 |
|---|---|---|---|
| K232444 | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs | 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?
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
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?
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy: Test Chemotherapy Drug (Concentration) Minimum Breakthrough Detection Time in minutes Fluorouracil (50.0mg/ml) >240 Etoposide (20.0mg/ml) >240…
Read the full statement (93 words)
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a
surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of
Medical Gloves to Permeation by Chemotherapy:
Test Chemotherapy Drug (Concentration) Minimum Breakthrough Detection Time in minutes
Fluorouracil (50.0mg/ml) >240
Etoposide (20.0mg/ml) >240
Cyclophosphamide (20.0mg/ml) >240
Carmustine (3.3mg/ml) 13.2
Thiotepa (10.0mg/ml) 12.0
Paclitaxel (6.0mg/ml) >240
Doxorubicin Hydrochloride (2.0mg/ml) >240
Methotrexate (25.0mg/ml) >240
Vincristine Sulfate (1.0mg/ml) >240
"WARNING: Do not use Carmustine and 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/K202765 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202765: ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and 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/K202765
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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