Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional Labeling Claim of E.P. Less Than 50 UG/DM2
FDA 510(k) K033564 · Kanam Latex Industries Pvt. , Ltd.
510(k) numberK033564
Submission
- Device name
- Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional Labeling Claim of E.P. Less Than 50 UG/DM2
- Applicant
- Kanam Latex Industries Pvt. , Ltd.
Kottayam, Kerala, IN - Received
- November 12, 2003
- Decision date
- February 24, 2004
- 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 |
|---|---|---|
| K052214 | Pre-Powdered Sterile Exam GlovesLYY · Traditional | 09/13/2005SE |
| K013914 | Powderfree Latex Surgeon's GlovesKGO · Traditional | 02/06/2002SE |
| K904972 | Surgicare Sterile Surgical GlovesKGO · Traditional | 01/31/1991SE |
| K897139 | Latex Patient Examination GlovesLYY · Traditional | 01/23/1990SE |
Questions and answers
When was Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional Labeling Claim of E.P. Less Than 50 UG/DM2 cleared by the FDA?
Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional Labeling Claim of E.P. Less Than 50 UG/DM2 (K033564) received a 510(k) decision of Substantially Equivalent on February 24, 2004, 104 days after the submission was received.
What is the product code of K033564?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.