Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove - Aloe Vera Coated Green Colour
FDA 510(k) K051562 · Terang Nusa Sdn Bhd
510(k) numberK051562
Submission
- Device name
- Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove - Aloe Vera Coated Green Colour
- Applicant
- Terang Nusa Sdn Bhd
Kota Bharu, Kelantan, MY - Received
- June 13, 2005
- Decision date
- October 20, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K170779 | Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms…LYY · Special | 05/24/2017SE |
| K161932 | Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene…LZA · Traditional | 11/28/2016SE |
| K153510 | Powder Free Polychloroprene Examination Glove GreenLZA · Traditional | 03/21/2016SE |
| K151392 | Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content…KGO · Traditional | 09/18/2015SE |
| K140355 | Sensiflex Plus Sterile Latex Surgical Glove Powderfree with Protein Content Labeling ClaimKGO · Traditional | 11/06/2014SE |
| K110698 | Nuzone X2T Chemo, Polychloroprene Synthetic Tan Surgical Gloves Powder FreeKGO · Traditional | 12/07/2011SE |
| K102230 | Nugard Nitile Grey ColorLZA · Special | 09/10/2010SE |
| K102119 | Sur-G Glov and MaxitexKGO · Special | 08/27/2010SE |
| K083337 | Nugard, Sensiflex Procedure Examination GlovesLYY · Special | 01/27/2009SE |
| K052837 | Sensiflex Plus Polymer Coated Latex Powder-Free Surgical Glove with Aloe VeraKGO · Special | 11/21/2005SE |
Questions and answers
When was Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove - Aloe Vera Coated Green Colour cleared by the FDA?
Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove - Aloe Vera Coated Green Colour (K051562) received a 510(k) decision of Substantially Equivalent on October 20, 2005, 129 days after the submission was received.
What is the product code of K051562?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.