Maxter Sterile Powdered Latex Surgical Gloves
FDA 510(k) K032467 · Maxter Glove Manufacturing Sdn Bhd
510(k) numberK032467
Submission
- Device name
- Maxter Sterile Powdered Latex Surgical Gloves
- Applicant
- Maxter Glove Manufacturing Sdn Bhd
Klang Selangor, MY - Received
- August 11, 2003
- Decision date
- October 10, 2003
- 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 |
|---|---|---|
| K172864 | Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy…LZC · Traditional | 05/02/2018SE |
| K151390 | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy DrugsLZC · Traditional | 05/02/2016SE |
| K113100 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsLZA · Traditional | 02/06/2012SE |
| K040176 | Maxter Powder Free Nitrile Medical Examination GlovesLZA · Traditional | 02/24/2004SE |
| K032501 | Maxter Sterile Powder Free Surgical GlovesKGO · Traditional | 10/17/2003SE |
| K013554 | Polymer Coated Powder Free Latex Medical Examination Gloves with Protein Labeling Claim…LYY · Traditional | 01/17/2002SE |
| K013498 | Chlorinated Powder Free Latex Medical Examination Gloves with Protein Labeling Claim (50…LYY · Traditional | 01/17/2002SE |
| K013443 | Powdered Latex Medical Medical Examination Gloves with 150 Micrograms or Less of Total…LYY · Traditional | 11/29/2001SE |
Questions and answers
When was Maxter Sterile Powdered Latex Surgical Gloves cleared by the FDA?
Maxter Sterile Powdered Latex Surgical Gloves (K032467) received a 510(k) decision of Substantially Equivalent on October 10, 2003, 60 days after the submission was received.
What is the product code of K032467?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.