Finger Cot
The Finger Cot (product code LZB) is a small, thimble-shaped disposable sheath worn over a single finger to provide a protective barrier during medical examinations or minor procedures, particularly in situations where a full glove is not required. Regulated under 21 CFR 880.6250 and classified as a Class 1 device subject only to general controls, it falls under the General Hospital specialty. It is not an implant, is not life-sustaining, and is not GMP-exempt.
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Basic Information
- Product Code
- LZB
- Device Class
- FDA class 1
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K052387 | ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX | Nov 29, 2005 | Substantially Equivalent | Arthrex, Inc. |
| K992539 | PERCUGUARD | Feb 18, 2000 | Substantially Equivalent | Digit-Pro |
| K980827 | LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING | May 04, 1998 | Substantially Equivalent | Tucker & Associates |
| K912042 | BETHEL PLUS MULTIPLE NAMES | Jul 02, 1991 | Substantially Equivalent | Bethel Latex Products, Inc. |
| K903073 | LATEX FINGER COTS | Sep 12, 1990 | Substantially Equivalent | Dongkuk Trading Co., Ltd. |
FEI Numbers
This FDA classification entry is associated with 71 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 71 registration numbers. Click on an entry to view related FDA registrations.