Product code KGO: 510(k) clearances and predicates
Product code KGO covers Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. FDA lists 560 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
560 clearances on file under product code KGO. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 6 |
| 2023 | 14 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 so far | 2 |
Recent clearances
Newest KGO clearances in the FDA index, with applicant and decision date:
- K260558, Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, applicant Hartalega NGC Sdn. Bhd., decided 2026-07-28. FDA record
- K253060, Sterile Latex Powder Free Surgical Gloves, applicant Protect Gloves Company Limited, decided 2026-05-22. FDA record
- K250313, Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid, applicant Harps Europe Manufacturing GmbH, decided 2025-08-19. FDA record
- K240790, Polyisoprene Surgical gloves, applicant Suzhou Colour-Way New Material Co., Ltd., decided 2024-08-23. FDA record
- K232079, Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl, applicant Wrp Asia Pacific Sdn. Bhd., decided 2024-03-28. FDA record
- K232444, Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs, applicant Grand Work Plastic Products Co., Ltd., decided 2023-12-20. FDA record
- K231902, GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090), applicant Ansell Healthcare, decided 2023-10-20. FDA record
- K231973, PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, applicant Ineo Tech Sdn Bhd, decided 2023-09-29. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Sterile Latex Powder Free Surgical Gloves, Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid. Watch new KGO clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code KGO?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KGO clearances include Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
How many 510(k) clearances use product code KGO?
560 at the time this page was generated, from openFDA records.
How do I find a predicate device under KGO?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new KGO clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.