NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR
FDA 510(k) K260794 · Kossan International Sdn Bhd
510(k) numberK260794
Submission
- Device name
- NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR
- Applicant
- Kossan International Sdn Bhd
Shah Alam, MY - Received
- March 11, 2026
- Decision date
- August 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LZA – Polymer Patient Examination Glove
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6250
- Specialty
- General Hospital
A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Other 510(k)s with product code LZA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262542 | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder…LZA · Special | Top Glove Sdn. Bhd. | 09/09/2026SE |
| K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and…LZA · Traditional | Maxter Healthcare, Inc. | 09/09/2026SE |
| K260312 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs…LZA · Special | Gmp Medicare Sdn. Bhd. | 09/08/2026SE |
| K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile…LZA · Special | O&M Halyard, Inc. | 07/21/2026SE |
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua…LZA · Special | Hartalega NGC Sdn. Bhd. | 07/20/2026SE |
| K252117 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with…LZA · Special | Sw Technologies, Inc. | 06/24/2026SE |
| K253824 | Powder Free Nitrile Examination Gloves Non-Sterile BlackLZA · Traditional | Kanglongda Vietnam Protection Technology Company… | 06/18/2026SE |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and…LZA · Special | Hartalega NGC Sdn. Bhd. | 06/17/2026SE |
| K260806 | Nitrile Disposable Examination GlovesLZA · Traditional | Vista Industries,, LLC | 06/03/2026SE |
| K260703 | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and…LZA · Traditional | S&S Glove Corporation | 06/03/2026SE |
More from S&S Glove Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K252549 | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for…LZA · Traditional | 01/13/2026SE |
| K232461 | Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with…LZA · Traditional | 11/14/2023SE |
| K230573 | Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein…LYY · Traditional | 06/13/2023SE |
| K191800 | Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling…LZA · Traditional | 09/16/2019SE |
| K190606 | Powder Free Nitrile Patient Examination Glove, Black Colored, Non-SterileLZA · Traditional | 05/28/2019SE |
| K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use…LZA · Traditional | 04/05/2019SE |
| K181857 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis…LZA · Traditional | 11/20/2018SE |
| K170397 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer…LZA · Traditional | 07/10/2017SE |
| K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free…LZA · Traditional | 08/03/2016SE |
| K160467 | Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with…LZA · Traditional | 08/02/2016SE |
Questions and answers
When was NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR cleared by the FDA?
NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR (K260794) received a 510(k) decision of Substantially Equivalent on August 18, 2026, 160 days after the submission was received.
What is the product code of K260794?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.