Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs
FDA 510(k) K200915 · Gx Corporation Sdn Bhd
510(k) numberK200915
Submission
- Device name
- Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs
- Applicant
- Gx Corporation Sdn Bhd
Klang, MY - Received
- April 6, 2020
- Decision date
- July 9, 2021
- 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 |
|---|---|---|
| K183354 | Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs…LZA · Traditional | 06/20/2019SE |
| K111328 | Powder Free Nitrile Examination GlovesLZA · Traditional | 07/15/2011SE |
| K102074 | Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, Blue (SG)LZA · Traditional | 11/02/2010SE |
| K101828 | Powder Free Latex Examination Gloves (18 ML), Blue Tested for Use with Chemotherapy DrugsLYY · Traditional | 10/04/2010SE |
| K091851 | Sterile, Powder Free Nitrile Examination Glove, Blue, Tested for Use with Chemotherapy…LZA · Traditional | 12/28/2009SE |
| K092072 | Powder Free Nitrile Examination Glove, Grape Scented, BlueLZA · Traditional | 11/04/2009SE |
| K091643 | Powder Free Latex Examination Gloves, Blue, Tested for Use with Chemotherapy DrugsLZC · Traditional | 11/02/2009SE |
| K092200 | Powder Free Nitrile Examination Gloves, Orange (Orange Scented), White (Vanilla Scented)LZA · Traditional | 09/16/2009SE |
| K091151 | Powder Free Nitrile Examination Glove, Green Tea Scented, GreenLZA · Traditional | 06/01/2009SE |
| K090412 | Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White).LZA · Traditional | 06/01/2009SE |
Questions and answers
When was Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs cleared by the FDA?
Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs (K200915) received a 510(k) decision of Substantially Equivalent on July 9, 2021, 459 days after the submission was received.
What is the product code of K200915?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.