X-Tenda Cuff Powder Free Latex Surgical Gloves with Protein Content Labeling Claim 50 Micrograms or Less, Model Style 21
FDA 510(k) K003895 · Ansell Perry
510(k) numberK003895
Submission
- Device name
- X-Tenda Cuff Powder Free Latex Surgical Gloves with Protein Content Labeling Claim 50 Micrograms or Less, Model Style 21
- Applicant
- Ansell Perry
Massillon, OH, US - Received
- December 18, 2000
- Decision date
- January 17, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K002192 | Dermaguard PF Brown Powder Free Latex Surgical Gloves; Model Style 38KGO · Special | 07/27/2000SE |
| K001239 | Encore Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50…KGO · Special | 05/15/2000SE |
| K000165 | Next Step Powder Free Latex Examination Gloves Contains 50 MCGM or Less of Total Water…LYY · Traditional | 03/10/2000SE |
| K000295 | Encore Microptic Powder Free Latex Surgical Gloves with Protein Content Labeling Claim…KGO · Special | 02/16/2000SE |
| K993857 | The Original Perry, Style 42 White Latex Powdered Surgical Gloves with Protein Content…KGO · Traditional | 01/31/2000SE |
| K992953 | Surgeons Glove, Brown Latex Polymer Coated, Powder Free with Protein Label ClaimKGO · Traditional | 10/29/1999SE |
| K992156 | Synsation Sterile Powder Free, Polyvinyl Chloride Medical Examination GlovesLYZ · Traditional | 10/27/1999SE |
| K992768 | Nitra-Touch Sterile Powder-Free Nitrile Medical Examination GloveLZA · Traditional | 10/13/1999SE |
| K984559 | Elite Powder-Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use)KGO · Traditional | 02/26/1999SE |
| K984558 | Derma Prene Powder-Free Synthetic Surgical Gloves (Chemotherapy Use)KGO · Traditional | 02/26/1999SE |
Questions and answers
When was X-Tenda Cuff Powder Free Latex Surgical Gloves with Protein Content Labeling Claim 50 Micrograms or Less, Model Style 21 cleared by the FDA?
X-Tenda Cuff Powder Free Latex Surgical Gloves with Protein Content Labeling Claim 50 Micrograms or Less, Model Style 21 (K003895) received a 510(k) decision of Substantially Equivalent on January 17, 2001, 30 days after the submission was received.
What is the product code of K003895?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.