510(k) · Cleared
ClearedENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) 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 Aug 3, 2021 as substantially equivalent to K103714 (Ansell Healthcare Products, LLC, 2011) after a 146-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Aug 3, 2021
- Review
- 146 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983489 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK983489 Encore Mark IV Powder Free Polymer Coated Latex Surgical Glove with…Ansell Perry · 1998
- 1 generation backK103714 Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for…Ansell Healthcare Products, LLC · 2011
- This deviceK210724 ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein…Careplus (M) Sdn Bhd · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983489 | Encore Mark IV Powder Free Polymer Coated Latex Surgical Glove with Protein… | Ansell Perry | 1998 | — |
| −1 | K103714 | Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with… | Ansell Healthcare Products, LLC | 2011 | — |
| 0 (this device) | K210724 | ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content… | Careplus (M) Sdn Bhd | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K103714 | Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with ChemotheraSummary page 5…ree Latex Surgical Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim <50 µg/dm2 per Glove of Extractable Protein, 510(k) number K103714, product code KGO. 6.0 Intended Use of Device Powder Free Surgical gloves are sterile disposable devices intended to be wo… | 2011 |
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 12.6 years on median.
- None of the 3 ancestors has a recall.
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 (189 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) 14.1
Thiotepa (10.0mg/ml) 16.9
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 with Carmustine and Thiotepa"
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operatmg 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) 14.1
Thiotepa (10.0mg/ml) 16.9
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 with 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/K210724 · printed Nov 5, 2026
Cite this page
510(k) Report. “K210724: ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K210724
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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