Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
FDA 510(k) K212148 · Ansell Healthcare Products, LLC
510(k) numberK212148
Submission
- Device name
- Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
- Applicant
- Ansell Healthcare Products, LLC
Reno, NV, US - Received
- July 9, 2021
- Decision date
- March 10, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
|---|---|---|
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis…KGO · Traditional | 08/23/2023SE |
| K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy DrugsKGO · Traditional | 05/26/2023SE |
| K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with…LZA · Traditional | 06/13/2021SE |
| K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink…LZA · Traditional | 06/19/2020SE |
| K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy…KGO · Traditional | 05/23/2019SE |
| K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy DrugsKGO · Traditional | 03/22/2019SE |
| K171375 | Gammex PI Breach Detect Powder Free Surgical GloveKGO · Traditional | 02/06/2018SE |
| K171737 | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination GlovesLZA · Traditional | 12/29/2017SE |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - FlavoredMOL · Abbreviated | 08/02/2017SE |
| K163107 | Lifestyles Zero Lubricated Latex Male CondomHIS · Abbreviated | 01/23/2017SE |
Questions and answers
When was Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs cleared by the FDA?
Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs (K212148) received a 510(k) decision of Substantially Equivalent on March 10, 2022, 244 days after the submission was received.
What is the product code of K212148?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.