Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical Glove
FDA 510(k) K130450 · Purna Bina Sdn Bhd
510(k) numberK130450
Submission
- Device name
- Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical Glove
- Applicant
- Purna Bina Sdn Bhd
Kluang, Johor, MY - Received
- February 22, 2013
- Decision date
- September 30, 2014
- 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 |
|---|---|---|
| K083571 | Illusion Powder Free Exam Gloves, Natural Color with Vanilla Scent, Orange Color with…LYY · Traditional | 08/13/2009SE |
| K041004 | Illusion Powder Free-Polymer Coated Color Scented NR Latex Examination Gloves (Blue)LYY · Traditional | 07/02/2004SE |
| K022659 | Illusion Powder Free-Ploymer Coated Color Scented NR Latex Examination Gloves (Blue)LYY · Traditional | 09/25/2002SE |
| K003904 | Polymer Coated Powder Free Latex Examination GlovesLYY · Traditional | 01/24/2001SE |
| K994420 | Powder Free Latex Examination Patient GlovesLYY · Traditional | 09/18/2000SE |
| K891507 | Patient Examination Gloves (Latex)LYY · Traditional | 04/06/1989SE |
Questions and answers
When was Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical Glove cleared by the FDA?
Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical Glove (K130450) received a 510(k) decision of Substantially Equivalent on September 30, 2014, 585 days after the submission was received.
What is the product code of K130450?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.