Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate
FDA 510(k) K183354 · Gx Corporation Sdn Bhd
510(k) numberK183354
Submission
- Device name
- Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate
- Applicant
- Gx Corporation Sdn Bhd
Klang, MY - Received
- December 3, 2018
- Decision date
- June 20, 2019
- 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
| 510(k) | Device | Decision |
|---|---|---|
| K200915 | Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The…KGO · Traditional | 07/09/2021SE |
| K111328 | Powder Free Nitrile Examination GlovesLZA · Traditional | 07/15/2011SE |
| K102074 | Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, Blue (SG)LZA · Traditional | 11/02/2010SE |
| K101828 | Powder Free Latex Examination Gloves (18 ML), Blue Tested for Use with Chemotherapy DrugsLYY · Traditional | 10/04/2010SE |
| K091851 | Sterile, Powder Free Nitrile Examination Glove, Blue, Tested for Use with Chemotherapy…LZA · Traditional | 12/28/2009SE |
| K092072 | Powder Free Nitrile Examination Glove, Grape Scented, BlueLZA · Traditional | 11/04/2009SE |
| K091643 | Powder Free Latex Examination Gloves, Blue, Tested for Use with Chemotherapy DrugsLZC · Traditional | 11/02/2009SE |
| K092200 | Powder Free Nitrile Examination Gloves, Orange (Orange Scented), White (Vanilla Scented)LZA · Traditional | 09/16/2009SE |
| K091151 | Powder Free Nitrile Examination Glove, Green Tea Scented, GreenLZA · Traditional | 06/01/2009SE |
| K090412 | Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White).LZA · Traditional | 06/01/2009SE |
Questions and answers
When was Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate cleared by the FDA?
Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate (K183354) received a 510(k) decision of Substantially Equivalent on June 20, 2019, 199 days after the submission was received.
What is the product code of K183354?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.