LZB · Finger Cot
General Hospital · 21 CFR 880.6250 · Class 1
Overview
| Product Code | LZB |
|---|---|
| Device Name | Finger Cot |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Classification Rationale
Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K052387 | ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX | Arthrex, Inc. | Nov 29, 2005 | SESE |
| K992539 | PERCUGUARD | Digit-Pro | Feb 18, 2000 | SESE |
| K980827 | LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING | Tucker & Associates | May 4, 1998 | SESE |
| K912042 | BETHEL PLUS MULTIPLE NAMES | Bethel Latex Products, Inc. | Jul 2, 1991 | SESE |
| K903073 | LATEX FINGER COTS | Dongkuk Trading Co., Ltd. | Sep 12, 1990 | SESE |
Top Applicants
- Arthrex, Inc. — 1 clearance
- Bethel Latex Products, Inc. — 1 clearance
- Digit-Pro — 1 clearance
- Dongkuk Trading Co., Ltd. — 1 clearance
- Tucker & Associates — 1 clearance
