Submission Details
| 510(k) Number | K240930 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 04, 2024 |
| Decision Date | July 02, 2024 |
| Days to Decision | 89 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
K240930 is an FDA 510(k) clearance for the Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Sri Trang Gloves (Thailand) Public Company Limited (Hatyai, TH). The FDA issued a Cleared decision on July 2, 2024, 89 days after receiving the submission on April 4, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.
| 510(k) Number | K240930 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 04, 2024 |
| Decision Date | July 02, 2024 |
| Days to Decision | 89 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LZA — Polymer Patient Examination Glove |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.6250 |
| Definition | 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. |