Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
FDA 510(k) K183536 · Hartalega NGC Sdn. Bhd.
510(k) numberK183536
Submission
- Device name
- Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
- Applicant
- Hartalega NGC Sdn. Bhd.
Sepang, MY - Received
- December 19, 2018
- Decision date
- August 16, 2019
- 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 |
|---|---|---|
| K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl…KGO · Traditional | 07/28/2026SE |
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua…LZA · Special | 07/20/2026SE |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and…LZA · Special | 06/17/2026SE |
| K250861 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl…LZA · Traditional | 10/23/2025SE |
| K251319 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and…LZA · Traditional | 07/30/2025SE |
| K243818 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and…LZA · Special | 01/08/2025SE |
| K223437 | Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy…LZA · Traditional | 05/17/2023SE |
| K222225 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)LZA · Traditional | 11/11/2022SE |
| K221718 | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)KGO · Traditional | 09/24/2022SE |
| K214074 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per…KGO · Traditional | 05/26/2022SE |
Questions and answers
When was Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove cleared by the FDA?
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove (K183536) received a 510(k) decision of Substantially Equivalent on August 16, 2019, 240 days after the submission was received.
What is the product code of K183536?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.