Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs
FDA 510(k) K122999 · Top Glove Sdn. Bhd.
510(k) numberK122999
Submission
- Device name
- Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs
- Applicant
- Top Glove Sdn. Bhd.
Klang, Selangor, MY - Received
- September 27, 2012
- Decision date
- November 30, 2012
- 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 |
| 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 |
More from Vista Industries,, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K262542 | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder…LZA · Special | 09/09/2026SE |
| 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 |
| 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 Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs cleared by the FDA?
Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (K122999) received a 510(k) decision of Substantially Equivalent on November 30, 2012, 64 days after the submission was received.
What is the product code of K122999?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.