Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein
FDA 510(k) K202401 · Eco Medi Glove Sdn. Bhd.
510(k) numberK202401
Submission
- Device name
- Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein
- Applicant
- Eco Medi Glove Sdn. Bhd.
Taiping, MY - Received
- August 21, 2020
- Decision date
- February 17, 2021
- 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 |
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| K232764 | Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy…LZA · Traditional | 02/07/2024SE |
| K233405 | Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test ClaimLZA · Traditional | 12/28/2023SE |
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| K193121 | GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with…LZA · Traditional | 03/20/2020SE |
| K181066 | Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested…LZA · Traditional | 09/26/2018SE |
| K171339 | EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy…LZA · Traditional | 07/07/2017SE |
| K161187 | EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy…LZA · Traditional | 09/09/2016SE |
| K161320 | EMG Pink Nitrile Examination Glove Powder FreeLZA · Traditional | 09/01/2016SE |
| K152937 | EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint ScentedLZA · Traditional | 06/23/2016SE |
Questions and answers
When was Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein cleared by the FDA?
Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein (K202401) received a 510(k) decision of Substantially Equivalent on February 17, 2021, 180 days after the submission was received.
What is the product code of K202401?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.