Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
FDA 510(k) K200671 · Ansell Healthcare Products, LLC
510(k) numberK200671
Submission
- Device name
- Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
- Applicant
- Ansell Healthcare Products, LLC
Reno, NV, US - Received
- March 13, 2020
- Decision date
- June 19, 2020
- 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 |
| K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with…LZA · Traditional | 03/10/2022SE |
| K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with…LZA · Traditional | 06/13/2021SE |
| 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 Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for cleared by the FDA?
Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for (K200671) received a 510(k) decision of Substantially Equivalent on June 19, 2020, 98 days after the submission was received.
What is the product code of K200671?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.