510(k) · Cleared
ClearedSterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grand Work Plastic Products Co., Ltd. · KGO Surgeon'S Gloves
Cleared on Dec 20, 2023 as substantially equivalent to K202765 (Careplus (M) Sdn Bhd, 2021) after a 128-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Dec 20, 2023
- Review
- 128 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983489 (1998). 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 backK202765 ENCORE Latex Textured Surgical Gloves, Powder Free with Protein…Careplus (M) Sdn Bhd · 2021
- This deviceK232444 Sterile Powder Free Latex Surgical Gloves, Tested for Use with…Grand Work Plastic Products Co., Ltd. · 2023
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 | K202765 | ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content… | Careplus (M) Sdn Bhd | 2021 | — |
| 0 (this device) | K232444 | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy… | Grand Work Plastic Products Co., Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K202765 | ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim…Summary page 6…us (M) SDN BHD ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs (K202765). Reference device: Medline Industries, Inc. Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for… | 2021 |
| † | K202668 | Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use… | 2020 |
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 25 years and passes through 3 companies; a new generation was cleared every 22.5 years on median.
- None of the 2 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. 2023, 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?
The glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978. Chemotherapy Drug Minimum Breakthrough Detection Time (BDT) in Minutes Bleomycin Sulfate 15mg/ml (15000 ppm) >240 Busulfan 6mg/ml (6,000 ppm) >240 Carboplatin 10mg/ml (10,000 ppm) >240 Carmustine (BCNU)3.3 mg/ml (3,300 ppm) 14.0 Cisplatin 1mg/ml…
Read the full statement (197 words)
The glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978.
Chemotherapy Drug Minimum Breakthrough Detection Time (BDT) in Minutes
Bleomycin Sulfate 15mg/ml (15000 ppm) >240
Busulfan 6mg/ml (6,000 ppm) >240
Carboplatin 10mg/ml (10,000 ppm) >240
Carmustine (BCNU)3.3 mg/ml (3,300 ppm) 14.0
Cisplatin 1mg/ml (1,000 ppm) >240
Cyclophosphamide 20mg/ml (20,000 ppm) >240
Cytarabine HCL, 100 mg/ml (100,000 ppm) >240
Dacarbazine 10 mg/ml (10,000 ppm) >240
Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240
Etoposide, 20 mg/ml (20,000 ppm) >240
Epirubicin HCL, 2 mg/ml (2,000 ppm) >240
Fludarabine, 25 mg/ml (25,000 ppm) >240
Fluorouracil, 50mg/ml (50,000ppm) >240
Idarubicin HCL, 1mg/ml (1,000ppm) >240
Ifosfamide, 50mg/ml (50,000ppm) >240
Mechlorethamine HCI, 1mg/ml (1,000ppm) >240
Melphalan, 5mg/ml (5,000ppm) >240
Methotrexate, 25mg/ml (25,000ppm) >240
Mitomycin C, 0.5mg/ml (500ppm) >240
Mitoxantrone HCL, 2mg/ml (2,000ppm) >240
Paclitaxel, 6mg/ml (6,000ppm) >240
Paraplatin, 10mg/ml (10,000ppm) >240
Rituximab, 10mg/ml (10,000ppm) >240
Thio Tepa, 10mg/ml (10,000ppm) 16.1
Vincristine Sulfate, 1mg/ml (1,000ppm) >240
Please note that the following drugs have low permeation times:
Carmustine (BCNU): 14.0 minutes, Thiotepa: 16.1 minutes
Warning: Do not use with Carmustine and Thiotepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232444: Sterile Powder Free Latex Surgical Gloves, 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/K232444
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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