Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim
FDA 510(k) K262542 · Top Glove Sdn. Bhd.
510(k) numberK262542
Submission
- Device name
- Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim
- Applicant
- Top Glove Sdn. Bhd.
Klang, MY - Received
- July 23, 2026
- Decision date
- September 9, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K192111 | Biodegradable Nitrile Examination Powder Free Glove, GreenLZA · Traditional | 09/03/2020SE |
| K193150 | Latex Examination Powder Free Glove, Aloe VeraLZA · Traditional | 06/05/2020SE |
| K172923 | Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder…LZA · Traditional | 04/26/2018SE |
| K171279 | Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and…KGO · Traditional | 10/12/2017SE |
| K122999 | Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy DrugsLZA · Traditional | 11/30/2012SE |
| K023974 | Aloe Vera & Vitamin E Powderfree Latex Examination GlovesLYY · Traditional | 02/13/2003SE |
| K021855 | Top Glove Powderfree Latex Examination Glove with Protein Labelling Claims (50…LYY · Traditional | 08/05/2002SE |
| K993664 | Synthetic Vinyl Medical Examination Powdered GlovesLYZ · Traditional | 01/11/2000SE |
| K993605 | Pepper Green Mint Powdered Latex Examination GlovesLYY · Traditional | 12/20/1999SE |
| K993452 | Green Powdered Latex Examination GlovesLYY · Traditional | 12/20/1999SE |
Questions and answers
When was Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim cleared by the FDA?
Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim (K262542) received a 510(k) decision of Substantially Equivalent on September 9, 2026, 48 days after the submission was received.
What is the product code of K262542?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.