Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
FDA 510(k) K213993 · Careglove Global Sdn. Bhd.
510(k) numberK213993
Submission
- Device name
- Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
- Applicant
- Careglove Global Sdn. Bhd.
Seremban, MY - Received
- December 21, 2021
- Decision date
- August 5, 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 |
|---|---|---|
| K250578 | Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl…LZA · Special | 04/01/2025SE |
| K230121 | Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl…LZA · Traditional | 05/15/2023SE |
| K220859 | Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)LZA · Traditional | 09/09/2022SE |
| K211666 | Powder Free Nitrile Examination Gloves, Blue ChemotestLZA · Traditional | 01/09/2022SE |
| K190241 | Sterile Latex Surgical Glove, Powder FreeKGO · Traditional | 12/30/2019SE |
| K172015 | Powder Free Nitrile Examination Gloves, Blue (Colored)LZA · Traditional | 09/26/2017SE |
| K161833 | Latex Examination Glove Powder FreeLYY · Traditional | 05/23/2017SE |
Questions and answers
When was Powder Free Chloroprene Examination Glove Coloured (Blue, Green) cleared by the FDA?
Powder Free Chloroprene Examination Glove Coloured (Blue, Green) (K213993) received a 510(k) decision of Substantially Equivalent on August 5, 2022, 227 days after the submission was received.
What is the product code of K213993?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.