Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
FDA 510(k) K180644 · Hartalega Sdn Bhd
510(k) numberK180644
Submission
- Device name
- Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
- Applicant
- Hartalega Sdn Bhd
Bandar Sri Damansara, MY - Received
- March 12, 2018
- Decision date
- August 10, 2018
- 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 |
|---|---|---|
| K201748 | Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less…KGO · Traditional | 10/02/2020SE |
| K201531 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and…LZA · Traditional | 08/05/2020SE |
| K200897 | Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue)…KGO · Traditional | 06/01/2020SE |
| K180645 | Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with…LZA · Traditional | 11/16/2018SE |
| K180786 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs…LZA · Traditional | 11/02/2018SE |
| K173509 | Biodegradable Nitrile Powder Free Examination Glove (Blue)LZA · Traditional | 08/17/2018SE |
| K180505 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis…LZA · Traditional | 06/14/2018SE |
| K173137 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)LZA · Traditional | 12/12/2017SE |
| K171874 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and…LZA · Traditional | 10/12/2017SE |
| K170152 | Polychloroprene Powder Free Surgical Glove (Green)KGO · Traditional | 05/05/2017SE |
Questions and answers
When was Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green cleared by the FDA?
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green (K180644) received a 510(k) decision of Substantially Equivalent on August 10, 2018, 151 days after the submission was received.
What is the product code of K180644?
The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.