Biogel Skinsense Powder-Free Non-Latex Surgeon's Glove
FDA 510(k) K053102 · Regent Medical Americas, LLC
510(k) numberK053102
Submission
- Device name
- Biogel Skinsense Powder-Free Non-Latex Surgeon's Glove
- Applicant
- Regent Medical Americas, LLC
Norcross, GA, US - Received
- November 4, 2005
- Decision date
- March 10, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K053441 | Biogel Latex Powder Free Sterile Surgeon's GloveKGO · Traditional | 04/10/2006SE |
| K053442 | Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex GloveKGO · Traditional | 03/07/2006SE |
| K053443 | Biogel Eclipse Non-Pyrogenic Latex Powder-Free Sterile Surgeon's GloveKGO · Traditional | 02/01/2006SE |
| K050899 | Biogel Latex Sterile Powder-Free GloveKGO · Traditional | 08/12/2005SE |
| K050533 | Eclipse Latex Powder Free Sterile Surgeon's GloveKGO · Traditional | 04/26/2005SE |
| K050184 | Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex GloveKGO · Traditional | 03/16/2005SE |
Questions and answers
When was Biogel Skinsense Powder-Free Non-Latex Surgeon's Glove cleared by the FDA?
Biogel Skinsense Powder-Free Non-Latex Surgeon's Glove (K053102) received a 510(k) decision of Substantially Equivalent on March 10, 2006, 126 days after the submission was received.
What is the product code of K053102?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.