Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
FDA 510(k) K160781 · Semperit Investments Asia Pte , Ltd.
510(k) numberK160781
Submission
- Device name
- Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
- Applicant
- Semperit Investments Asia Pte , Ltd.
Singapore, SG - Received
- March 22, 2016
- Decision date
- May 2, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|
| K223903 | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with…LZA · Special | 01/27/2023SE |
| K183441 | Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low…LZA · Traditional | 10/04/2019SE |
| K171378 | Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy…LZA · Traditional | 09/14/2017SE |
Questions and answers
When was Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves cleared by the FDA?
Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves (K160781) received a 510(k) decision of Substantially Equivalent on May 2, 2017, 406 days after the submission was received.
What is the product code of K160781?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.