Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
FDA 510(k) K161932 · Terang Nusa Sdn Bhd
510(k) numberK161932
Submission
- Device name
- Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
- Applicant
- Terang Nusa Sdn Bhd
Kota Bharu, MY - Received
- July 14, 2016
- Decision date
- November 28, 2016
- 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 |
|---|---|---|
| K170779 | Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms…LYY · Special | 05/24/2017SE |
| 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 |
| K102230 | Nugard Nitile Grey ColorLZA · Special | 09/10/2010SE |
| 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 Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink cleared by the FDA?
Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink (K161932) received a 510(k) decision of Substantially Equivalent on November 28, 2016, 137 days after the submission was received.
What is the product code of K161932?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.