K202449 is an FDA 510(k) clearance for the Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein. This device is classified as a Surgeon's Gloves (Class I - General Controls, product code KGO).
Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on November 18, 2020, 84 days after receiving the submission on August 26, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4460. A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants..
| 510(k) Number | K202449 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2020 |
| Decision Date | November 18, 2020 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KGO — Surgeon's Gloves |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4460 |
| Definition | A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants. |