Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs
FDA 510(k) K211220 · Guangdong Kingfa Sci. & Tech.Co., Ltd.
510(k) numberK211220
Submission
- Device name
- Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs
- Applicant
- Guangdong Kingfa Sci. & Tech.Co., Ltd.
Qingyuan, CN - Received
- April 23, 2021
- Decision date
- July 22, 2021
- 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 |
|---|---|---|
| K233723 | Medical surgical maskFXX · Traditional | 07/29/2024SE |
| K231155 | Biodegradable Medical surgical maskFXX · Traditional | 11/07/2023SE |
| K221983 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder…LZA · Traditional | 04/27/2023SE |
| K230046 | Vinyl examination glovesLYZ · Traditional | 03/25/2023SE |
| K222612 | Powder-Free Latex examination glovesLYY · Traditional | 11/25/2022SE |
| K222714 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…LZA · Special | 10/07/2022SE |
| K221887 | Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile…LZA · Traditional | 09/24/2022SE |
| K213040 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…LZA · Special | 04/27/2022SE |
| K213450 | Medical surgical mask (Black mask, Level 1 and Level 3)FXX · Traditional | 04/05/2022SE |
| K203593 | Patient Examination GlovesLZA · Traditional | 03/19/2021SE |
Questions and answers
When was Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs cleared by the FDA?
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs (K211220) received a 510(k) decision of Substantially Equivalent on July 22, 2021, 90 days after the submission was received.
What is the product code of K211220?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.