FDA product code KGO: Surgeon'S Gloves
KGO is the FDA product code for surgeon's gloves. It is a Class I device, regulated under 21 CFR 878.4460 and reviewed by the General Hospital panel. FDA has cleared 560 510(k) submissions under KGO, 25 in the last five years, from 267 different applicants. The average 510(k) review took 126 days (median 98); 201 days on average over the last three years. FDA has posted 44 recalls for KGO devices, 5 initiated in the last five years.
Definition
A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Classification
| Field | Value |
|---|---|
| Device name | Surgeon'S Gloves |
| Device class | Class I |
| Regulation | 21 CFR 878.4460 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KGO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 12 | 138 |
| 2018 | 7 | 219 |
| 2019 | 11 | 196 |
| 2020 | 15 | 140 |
| 2021 | 14 | 230 |
| 2022 | 6 | 163 |
| 2023 | 14 | 210 |
| 2024 | 2 | 206 |
| 2025 | 1 | 197 |
| 2026 | 2 | 200 |
Compare with all 510(k) review times · Search every KGO clearance
Top KGO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wrp Asia Pacific Sdn. Bhd. | 20 | 2024-03-28 |
| Molnlycke Health Care Us, LLC | 16 | 2020-11-22 |
| Terang Nusa Sdn Bhd | 15 | 2015-09-18 |
| Ansell Perry | 15 | 2001-01-17 |
| Wembley Rubber Products (M) Sdn Bhd | 15 | 1999-03-12 |
262 more applicants have KGO clearances. See the full list in Caduvo.
Most recent KGO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260558 | Hartalega NGC Sdn. Bhd. | 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 | 2026-07-28 | 159 |
| K253060 | Protect Gloves Company Limited | Sterile Latex Powder Free Surgical Gloves | 2026-05-22 | 242 |
| K250313 | Harps Europe Manufacturing GmbH | Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid | 2025-08-19 | 197 |
| K240790 | Suzhou Colour-Way New Material Co., Ltd. | Polyisoprene Surgical gloves | 2024-08-23 | 154 |
| K232079 | Wrp Asia Pacific Sdn. Bhd. | 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 | 2024-03-28 | 259 |
Recalls for KGO devices
44 product recalls in 16 recall events; 5 initiated in the last five years and 4 still open. Most recent: 2026-02-27.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 9 |
| 2020 | 8 |
| 2022 | 2 |
| 2023 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code KGO?
KGO is the FDA product code for surgeon's gloves. It is a Class I device, regulated under 21 CFR 878.4460 and reviewed by the General Hospital panel.
What device class is KGO?
Class I, regulation 21 CFR 878.4460. Typical premarket route: 510(k).
How long does a 510(k) take for product code KGO?
Across 560 cleared submissions the average was 126 days from receipt to decision (median 98).
Which companies have the most KGO clearances?
Wrp Asia Pacific Sdn. Bhd. (20); Molnlycke Health Care Us, LLC (16); Terang Nusa Sdn Bhd (15); Ansell Perry (15); Wembley Rubber Products (M) Sdn Bhd (15).
Have KGO devices been recalled?
Yes: 44 product recalls across 16 recall events; the most recent began 2026-02-27.
Next steps
- Run an FDA pathway report with predicate devices for product code KGO
- Run a recall and safety report across every KGO manufacturer
- Watch product code KGO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times