Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
FDA 510(k) K172420 · Wear Safe (Malaysia) Sdn. Bhd.
510(k) numberK172420
Submission
- Device name
- Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
- Applicant
- Wear Safe (Malaysia) Sdn. Bhd.
Klang, MY - Received
- August 10, 2017
- Decision date
- September 29, 2017
- 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 |
|---|---|---|
| K101799 | Powder Free Latex Examination Gloves Blue (Colored), Non-Sterile, with Protein Labeling…LYY · Traditional | 09/03/2010SE |
| K093500 | Powder Free Nitrile Examination Gloves, White (Non-Colored) or Blue (Colored), Non-SterileLZC · Traditional | 01/19/2010SE |
| K092492 | Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling…LYY · Traditional | 10/21/2009SE |
| K090066 | Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling Claim…KGO · Traditional | 05/15/2009SE |
| K090327 | Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling…LYY · Traditional | 04/03/2009SE |
| K062917 | Sterile and Non-Sterile Powder-Free Latex Patient Examination Glove, with Extractable…LYY · Traditional | 11/02/2006SE |
| K062778 | Sterile Powder-Free Nitrile Patient Examination Glove, Blue ColoredLZA · Traditional | 10/27/2006SE |
| K992675 | Patient Nitrile Examination Gloves (Powdered)LZA · Traditional | 01/20/2000SE |
| K992681 | Patient Latex Examination Glove Powdered & Powder Free, SterileLYY · Traditional | 12/16/1999SE |
| K992676 | Patient Latex Examination Powder-Free Polymer Coated GlovesLYY · Traditional | 12/16/1999SE |
Questions and answers
When was Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim cleared by the FDA?
Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim (K172420) received a 510(k) decision of Substantially Equivalent on September 29, 2017, 50 days after the submission was received.
What is the product code of K172420?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.