Vanish II
FDA 510(k) K833093 · Warner-Lambert Co.
510(k) numberK833093
Submission
- Device name
- Vanish II
- Applicant
- Warner-Lambert Co.
Mchenry, IL, US - Received
- September 12, 1983
- Decision date
- December 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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|---|---|---|
| K024160 | Neosporin Scar SolutionMDA · Traditional | 03/17/2003SE |
| K893452 | Extra Strength Effergrip Denture Adhesive CreamIZZ · Traditional | 06/22/1989SE |
| K870584 | O.P.T.(Tm) Ovulation Prediction TestCEP · Traditional | 11/25/1987SE |
| K861510 | Multilumen Viapic Central Line CatheterFOZ · Traditional | 06/09/1986SE |
| K852967 | General Diagnostics' Ceftriaxone 30MCG Susdep DiskJTN · Traditional | 08/19/1985SE |
| K852689 | General Diagnostics Ceftazidime 30 MCG Susc DiskJTN · Traditional | 08/19/1985SE |
| K852843 | General Diagnostics Coag-A-Mate XCKQC · Traditional | 08/13/1985SE |
| K852889 | General Diagnostics Rapid E. Coli TestJTO · Traditional | 07/23/1985SE |
| K850486 | General Diag. Chromostrate Heparin AssayKFF · Traditional | 05/08/1985SE |
| K850412 | Gen. Diag. Chromostrate Antithrombin III AssayJBQ · Traditional | 05/08/1985SE |
Questions and answers
When was Vanish II cleared by the FDA?
Vanish II (K833093) received a 510(k) decision of Substantially Equivalent on December 12, 1983, 91 days after the submission was received.
What is the product code of K833093?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.