Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)
FDA 510(k) K260867 · Hartalega NGC Sdn. Bhd.
510(k) numberK260867
Submission
- Device name
- Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)
- Applicant
- Hartalega NGC Sdn. Bhd.
Sepang, MY - Received
- March 17, 2026
- Decision date
- June 17, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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 |
| K260794 | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT…LZA · Traditional | Kossan International Sdn Bhd | 08/18/2026SE |
| 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 |
| 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 |
|---|---|---|
| K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl…KGO · Traditional | 07/28/2026SE |
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua…LZA · Special | 07/20/2026SE |
| K250861 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl…LZA · Traditional | 10/23/2025SE |
| K251319 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and…LZA · Traditional | 07/30/2025SE |
| K243818 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and…LZA · Special | 01/08/2025SE |
| K223437 | Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy…LZA · Traditional | 05/17/2023SE |
| K222225 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)LZA · Traditional | 11/11/2022SE |
| K221718 | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)KGO · Traditional | 09/24/2022SE |
| K214074 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per…KGO · Traditional | 05/26/2022SE |
| K211758 | Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs…OPC · Traditional | 08/03/2021SE |
Questions and answers
When was Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) cleared by the FDA?
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) (K260867) received a 510(k) decision of Substantially Equivalent on June 17, 2026, 92 days after the submission was received.
What is the product code of K260867?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.