ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
FDA 510(k) K210656 · Careplus (M) Sdn Bhd
510(k) numberK210656
Submission
- Device name
- ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
- Applicant
- Careplus (M) Sdn Bhd
Seremban, MY - Received
- March 4, 2021
- Decision date
- June 24, 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 |
|---|---|---|
| K211621 | Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)KGO · Traditional | 10/06/2021SE |
| K203705 | Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or…LYY · Traditional | 08/20/2021SE |
| K201857 | Powder Free Nitrile Examination Glove Black and Dual Color White-BlueLZA · Traditional | 08/20/2021SE |
| K210724 | ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling…KGO · Traditional | 08/03/2021SE |
| K202765 | ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim…KGO · Traditional | 05/27/2021SE |
| K162858 | Nitrilecare Nitrile Examination Gloves Powder Free, Blue, ChemotestLZC · Traditional | 07/24/2017SE |
| K152593 | Latex Examination Glove Powder FreeLYY · Traditional | 02/25/2016SE |
| K142858 | POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)LZA · Traditional | 02/09/2015SE |
| K142862 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).LZA · Traditional | 01/16/2015SE |
Questions and answers
When was ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs cleared by the FDA?
ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs (K210656) received a 510(k) decision of Substantially Equivalent on June 24, 2021, 112 days after the submission was received.
What is the product code of K210656?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.