Bantex Surgical Latex Gloves- Type 1 Natural Rubber Latex Surgicsl Gloves, Sterile
FDA 510(k) K963218 · American Bantex Corp.
510(k) numberK963218
Submission
- Device name
- Bantex Surgical Latex Gloves- Type 1 Natural Rubber Latex Surgicsl Gloves, Sterile
- Applicant
- American Bantex Corp.
Burlingame, CA, US - Received
- August 16, 1996
- Decision date
- October 30, 1996
- 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.
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|---|---|---|
| K042104 | American Bantex, Model MS 3INI · Traditional | 10/21/2004SE |
| K041963 | American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and B9100, 6 PsiBTT · Traditional | 10/20/2004SE |
| K040754 | American Bantex MS 4 Mini ScooterINI · Traditional | 07/23/2004SE |
| K031711 | Tango, Models, BP1ITI · Traditional | 12/18/2003SE |
Questions and answers
When was Bantex Surgical Latex Gloves- Type 1 Natural Rubber Latex Surgicsl Gloves, Sterile cleared by the FDA?
Bantex Surgical Latex Gloves- Type 1 Natural Rubber Latex Surgicsl Gloves, Sterile (K963218) received a 510(k) decision of Substantially Equivalent on October 30, 1996, 75 days after the submission was received.
What is the product code of K963218?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.