Sterile Polyisoprene Powder Free Surgical Gloves
FDA 510(k) K171047 · Better Care Plastic Technology Co., Ltd.
510(k) numberK171047
Submission
- Device name
- Sterile Polyisoprene Powder Free Surgical Gloves
- Applicant
- Better Care Plastic Technology Co., Ltd.
Shenze County, CN - Received
- April 7, 2017
- Decision date
- June 22, 2017
- 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 |
|---|---|---|
| K242533 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low…LZA · Traditional | 03/18/2025SE |
| K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for…LZA · Traditional | 11/03/2023SE |
| K232070 | Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and…LZA · Traditional | 10/11/2023SE |
| K231567 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy…LZA · Traditional | 10/04/2023SE |
| K223713 | Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and…LZA · Traditional | 08/07/2023SE |
| K222449 | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And…LZC · Traditional | 08/27/2022SE |
| K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and…LZA · Traditional | 07/27/2022SE |
| K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)LZA · Traditional | 11/30/2018SE |
| K171898 | Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy DrugsKGO · Traditional | 08/18/2017SE |
| K140816 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)LZA · Traditional | 07/08/2014SE |
Questions and answers
When was Sterile Polyisoprene Powder Free Surgical Gloves cleared by the FDA?
Sterile Polyisoprene Powder Free Surgical Gloves (K171047) received a 510(k) decision of Substantially Equivalent on June 22, 2017, 76 days after the submission was received.
What is the product code of K171047?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.