Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
FDA 510(k) K200897 · Hartalega Sdn Bhd
510(k) numberK200897
Submission
- Device name
- Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
- Applicant
- Hartalega Sdn Bhd
Bandar Sri Damansara, MY - Received
- April 3, 2020
- Decision date
- June 1, 2020
- 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 |
|---|---|---|
| K201748 | Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less…KGO · Traditional | 10/02/2020SE |
| K201531 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and…LZA · Traditional | 08/05/2020SE |
| K180645 | Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with…LZA · Traditional | 11/16/2018SE |
| K180786 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs…LZA · Traditional | 11/02/2018SE |
| K173509 | Biodegradable Nitrile Powder Free Examination Glove (Blue)LZA · Traditional | 08/17/2018SE |
| K180644 | Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon GreenLZA · Traditional | 08/10/2018SE |
| K180505 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis…LZA · Traditional | 06/14/2018SE |
| K173137 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)LZA · Traditional | 12/12/2017SE |
| K171874 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and…LZA · Traditional | 10/12/2017SE |
| K170152 | Polychloroprene Powder Free Surgical Glove (Green)KGO · Traditional | 05/05/2017SE |
Questions and answers
When was Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) cleared by the FDA?
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) (K200897) received a 510(k) decision of Substantially Equivalent on June 1, 2020, 59 days after the submission was received.
What is the product code of K200897?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.