Finger Cot
FDA product code LZB · Class I (low risk) · 21 CFR 880.6250 · General Hospital
5510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052387 | Arthrex Fingershield Finger Guard, Model AR-7199-XXLZB · Traditional | Arthrex, Inc. | 11/29/2005SE |
| K992539 | PercuguardLZB · Traditional | Digit-Pro | 02/18/2000SE |
| K980827 | Latex Finger Cot, Powder-Free, with Protein LabelingLZB · Traditional | Tucker & Associates | 05/04/1998SE |
| K912042 | Bethel Plus Multiple NamesLZB · Traditional | Bethel Latex Products, Inc. | 07/02/1991SE |
| K903073 | Latex Finger CotsLZB · Traditional | Dongkuk Trading Co., Ltd. | 09/12/1990SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1811-2016 Class II | Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and…Product packaging defective compromising sterility | American Surgical Company | 03/31/2016Terminated |