Nitrile Blue Powder-free Examination Glove
FDA 510(k) K211390 · Cardinal Health200, LLC
510(k) numberK211390
Submission
- Device name
- Nitrile Blue Powder-free Examination Glove
- Applicant
- Cardinal Health200, LLC
Waukegan, IL, US - Received
- May 5, 2021
- Decision date
- August 28, 2021
- 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
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|---|---|---|
| K241780 | Cardinal Health Nitrile Exam GlovesLZA · Special | 08/23/2024SE |
| K230838 | Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument PocketsFYA · Traditional | 07/27/2023SE |
| K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan…MEG · Abbreviated | 06/21/2023SE |
| K230028 | Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express…JOW · Traditional | 04/03/2023SE |
| K201592 | Cardinal Health Protexis PI Blue with Neu-Thera Surgical GloveKGO · Traditional | 09/26/2021SE |
| K200824 | Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR…FYA · Traditional | 07/29/2020SE |
| K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus…FYA · Traditional | 03/20/2020SE |
| K192374 | Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam StripFXX · Traditional | 12/02/2019SE |
| K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective GownQPC · Traditional | 04/26/2019SE |
| K181174 | Cardinal Health Sterilization WrapFRG · Traditional | 12/11/2018SE |
Questions and answers
When was Nitrile Blue Powder-free Examination Glove cleared by the FDA?
Nitrile Blue Powder-free Examination Glove (K211390) received a 510(k) decision of Substantially Equivalent on August 28, 2021, 115 days after the submission was received.
What is the product code of K211390?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.