Nugard Nitile Grey Color
FDA 510(k) K102230 · Terang Nusa Sdn Bhd
510(k) numberK102230
Submission
- Device name
- Nugard Nitile Grey Color
- Applicant
- Terang Nusa Sdn Bhd
Kota Bharu, Kelantan, MY - Received
- August 9, 2010
- Decision date
- September 10, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K170779 | Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms…LYY · Special | 05/24/2017SE |
| K161932 | Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene…LZA · Traditional | 11/28/2016SE |
| K153510 | Powder Free Polychloroprene Examination Glove GreenLZA · Traditional | 03/21/2016SE |
| K151392 | Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content…KGO · Traditional | 09/18/2015SE |
| K140355 | Sensiflex Plus Sterile Latex Surgical Glove Powderfree with Protein Content Labeling ClaimKGO · Traditional | 11/06/2014SE |
| K110698 | Nuzone X2T Chemo, Polychloroprene Synthetic Tan Surgical Gloves Powder FreeKGO · Traditional | 12/07/2011SE |
| K102119 | Sur-G Glov and MaxitexKGO · Special | 08/27/2010SE |
| K083337 | Nugard, Sensiflex Procedure Examination GlovesLYY · Special | 01/27/2009SE |
| K052837 | Sensiflex Plus Polymer Coated Latex Powder-Free Surgical Glove with Aloe VeraKGO · Special | 11/21/2005SE |
| K051562 | Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove - Aloe…KGO · Traditional | 10/20/2005SE |
Questions and answers
When was Nugard Nitile Grey Color cleared by the FDA?
Nugard Nitile Grey Color (K102230) received a 510(k) decision of Substantially Equivalent on September 10, 2010, 32 days after the submission was received.
What is the product code of K102230?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.