Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves
FDA 510(k) K063757 · Shanghai Motex Healthcare Co., Ltd.
510(k) numberK063757
Submission
- Device name
- Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves
- Applicant
- Shanghai Motex Healthcare Co., Ltd.
Hsin Chu City, TW - Received
- December 19, 2006
- Decision date
- July 27, 2007
- 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 |
|---|---|---|
| K123126 | Motex Polyisoprene Powder-Free Surgical Gloves Model # 6412(6432) and # 6512(6532)KGO · Traditional | 06/04/2014SE |
| K132802 | Motex Powdered Nitrile Surgical GlovesKGO · Traditional | 05/21/2014SE |
| K122557 | Motex Powder-Free Nitrile Surgical GlovesKGO · Traditional | 10/03/2013SE |
| K041276 | Powder-Free Nitrile Examination GlovesLZA · Traditional | 08/20/2004SE |
| K030207 | Nitrile Powder-Free Examination Gloves, Problue, #7235 7 #7735LZA · Traditional | 05/02/2003SE |
| K020837 | Motex Latex Examination Gloves, Powder-FreeLYY · Traditional | 12/02/2002SE |
| K013261 | Motex Nitrile Examination Gloves Powder-FreeLZA · Traditional | 11/29/2001SE |
Questions and answers
When was Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves cleared by the FDA?
Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves (K063757) received a 510(k) decision of Substantially Equivalent on July 27, 2007, 220 days after the submission was received.
What is the product code of K063757?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.