Esteem Ortho Polyisoprene Powder-Free Surgical Gloves
FDA 510(k) K092304 · Cardinal Health, Inc.
510(k) numberK092304
Submission
- Device name
- Esteem Ortho Polyisoprene Powder-Free Surgical Gloves
- Applicant
- Cardinal Health, Inc.
Waukegan, IL, US - Received
- July 29, 2009
- Decision date
- September 15, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- KGO – Surgeon'S Gloves
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4460
- Specialty
- General, Plastic Surgery
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.
Other 510(k)s with product code KGO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl…KGO · Traditional | Hartalega NGC Sdn. Bhd. | 07/28/2026SE |
| K253060 | Sterile Latex Powder Free Surgical GlovesKGO · Traditional | Protect Gloves Company Limited | 05/22/2026SE |
| K250313 | Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With…KGO · Abbreviated | Harps Europe Manufacturing GmbH | 08/19/2025SE |
| K240790 | Polyisoprene Surgical glovesKGO · Traditional | Suzhou Colour-Way New Material Co., Ltd. | 08/23/2024SE |
| K232079 | Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with…KGO · Traditional | Wrp Asia Pacific Sdn. Bhd. | 03/28/2024SE |
| K232444 | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsKGO · Traditional | Grand Work Plastic Products Co., Ltd. | 12/20/2023SE |
| K231902 | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid…KGO · Traditional | Ansell Healthcare | 10/20/2023SE |
| K231973 | PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical GloveKGO · Traditional | Ineo Tech Sdn Bhd | 09/29/2023SE |
| K231446 | Single-Use Latex Sterile Surgical Gloves (SG100)KGO · Traditional | Fitone Latex Products Co., Ltd. Guangdong | 09/22/2023SE |
| K230578 | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with…KGO · Traditional | Wrp Asia Pacific Sdn. Bhd. | 08/31/2023SE |
More from Wrp Asia Pacific Sdn. Bhd.
| 510(k) | Device | Decision |
|---|---|---|
| K221603 | Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD…LZH · Traditional | 12/20/2022SE |
| K211765 | Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse GownFYA · Traditional | 11/23/2021SE |
| K170198 | Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use…KGO · Traditional | 06/15/2017SE |
| K160411 | Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera CoatingLYZ · Traditional | 07/25/2016SE |
| K160875 | Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with…KGO · Traditional | 07/11/2016SE |
| K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and…KGO · Traditional | 05/12/2016SE |
| K122696 | Powder-Free Nitrile Examination Gloves (Cool Blue)LZA · Traditional | 01/31/2013SE |
| K121897 | Protexis Latex Basic Sterile Powder-Free Surgical GlovesKGO · Special | 07/27/2012SE |
| K120934 | Protexis Latex Basic Sterile Latex Powder-Free Surgical Glove with Protein Content Label…KGO · Traditional | 05/23/2012SE |
| K111878 | Protexis Latex Blue with Neu-Thera Powder-Free Surgical GlovesKGO · Traditional | 09/29/2011SE |
Questions and answers
When was Esteem Ortho Polyisoprene Powder-Free Surgical Gloves cleared by the FDA?
Esteem Ortho Polyisoprene Powder-Free Surgical Gloves (K092304) received a 510(k) decision of Substantially Equivalent on September 15, 2009, 48 days after the submission was received.
What is the product code of K092304?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.