Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue
FDA 510(k) K254285 · Hartalega NGC Sdn. Bhd.
510(k) numberK254285
Submission
- Device name
- Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue
- Applicant
- Hartalega NGC Sdn. Bhd.
Sepang, MY - Received
- December 31, 2025
- Decision date
- July 20, 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 |
| 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 |
|---|---|---|
| K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl…KGO · Traditional | 07/28/2026SE |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and…LZA · Special | 06/17/2026SE |
| 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 Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue cleared by the FDA?
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue (K254285) received a 510(k) decision of Substantially Equivalent on July 20, 2026, 201 days after the submission was received.
What is the product code of K254285?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.