FDA product code · General, Plastic Surgery
KGOSurgeon'S Gloves
Product code KGO covers Surgeon'S Gloves, a Class I device regulated under 21 CFR 878.4460. FDA has cleared 559 devices in this code, 2 of them in the last 12 months. Median review time across the 559 most recent decisions is 98 days. openFDA lists 44 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 878.4460
- Review panel
- General, Plastic Surgery
- Clearances
- 559
What is happening in KGO right now?
KGO (Surgeon'S Gloves) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class I) (Z-1725-2026). 2 first-time filers in the last 12 months, Protect Gloves Company Limited and Harps Europe Manufacturing GmbH (K253060, K250313). The code is crowded, scoring 79 of 100 — 260 companies hold a clearance here and 2 arrived in the last 12 months (KGO:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class I recall | Z-1725-2026 |
| New entrant | Worth knowing | K253060, K250313 |
| Crowding | Context | KGO:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code KGO cover?
KGO is FDA's product code for Surgeon'S Gloves, a Class I device regulated under 21 CFR 878.4460.
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.
Source: openFDA device/classification · record KGO · retrieved
How many devices has FDA cleared in KGO?
FDA has cleared 559 devices under product code KGO since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253060 | Sterile Latex Powder Free Surgical Gloves | Protect Gloves Company Limited | |
| K250313 | Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid | Harps Europe Manufacturing GmbH | |
| K240790 | Polyisoprene Surgical gloves | Suzhou Colour-Way New Material Co., Ltd. | |
| 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 | Wrp Asia Pacific Sdn. Bhd. | |
| K232444 | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | |
| 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) | Ansell Healthcare | |
| K231973 | PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove | Ineo Tech Sdn Bhd | |
| K231446 | Single-Use Latex Sterile Surgical Gloves (SG100) | Fitone Latex Products Co., Ltd. Guangdong | |
| K230578 | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | Wrp Asia Pacific Sdn. Bhd. | |
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential | Ansell Healthcare Products, LLC |
How long does FDA review take for KGO?
The median FDA review time for KGO is 98 days, measured across the 559 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in KGO?
openFDA lists 44 recall records against product code KGO. A recall record covers one firm's corrective action and may span many device lots.
Z-1725-2026Open, ClassifiedMedline Industries, LP
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Z-0096-2024Open, ClassifiedAnsell Healthcare Products LLC
Some surgical glove sterile pouches were not completely sealed.
Z-0097-2024Open, ClassifiedAnsell Healthcare Products LLC
Some surgical glove sterile pouches were not completely sealed.
Z-0902-2022CompletedCardinal Health 200, LLC
Product was distributed without being sterilized.
Z-0838-2022Open, ClassifiedAnsell Healthcare Products LLC
Transport company failed to stop at the border for required FDA inspection.
Showing the 5 most recently initiated of 44. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for KGO?
MAUDE holds 81 adverse-event reports naming product code KGO, 29 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in KGO unusual?
KGO does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history |
29 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered KGO in the last year?
2 companies filed in KGO for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Protect Gloves Company Limited | K253060 | |
| Harps Europe Manufacturing GmbH | K250313 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in KGO?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in KGO?
Across the 559 most recent decisions, these applicants filed most often in KGO.
| Applicant | Recent clearances |
|---|---|
| Wrp Asia Pacific Sdn. Bhd. | 20 |
| Molnlycke Health Care Us, LLC | 16 |
| Ansell Perry | 15 |
| Terang Nusa Sdn Bhd | 15 |
| Wembley Rubber Products (M) Sdn Bhd | 15 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in KGO files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Ansell Healthcare Products LLC | 16 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch KGO
Get an email the morning anything changes in KGO — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.