FDA product code LZB: Finger Cot
LZB is the FDA product code for finger cot. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel. FDA has cleared 5 510(k) submissions under LZB, from 5 different applicants. The average 510(k) review took 94 days (median 62). FDA has posted 1 recall for LZB devices.
Classification
| Field | Value |
|---|---|
| Device name | Finger Cot |
| Device class | Class I |
| Regulation | 21 CFR 880.6250 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LZB clearance
Top LZB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthrex, Inc. | 1 | 2005-11-29 |
| Digit-Pro | 1 | 2000-02-18 |
| Tucker & Associates | 1 | 1998-05-04 |
| Bethel Latex Products, Inc. | 1 | 1991-07-02 |
| Dongkuk Trading Co., Ltd. | 1 | 1990-09-12 |
Most recent LZB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052387 | Arthrex, Inc. | ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX | 2005-11-29 | 90 |
| K992539 | Digit-Pro | PERCUGUARD | 2000-02-18 | 203 |
| K980827 | Tucker & Associates | LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING | 1998-05-04 | 62 |
| K912042 | Bethel Latex Products, Inc. | BETHEL PLUS MULTIPLE NAMES | 1991-07-02 | 55 |
| K903073 | Dongkuk Trading Co., Ltd. | LATEX FINGER COTS | 1990-09-12 | 62 |
Recalls for LZB devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-03-31.
Frequently asked questions
What is FDA product code LZB?
LZB is the FDA product code for finger cot. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel.
What device class is LZB?
Class I, regulation 21 CFR 880.6250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LZB?
Across 5 cleared submissions the average was 94 days from receipt to decision (median 62).
Which companies have the most LZB clearances?
Arthrex, Inc. (1); Digit-Pro (1); Tucker & Associates (1); Bethel Latex Products, Inc. (1); Dongkuk Trading Co., Ltd. (1).
Have LZB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-03-31.
Next steps
- Run an FDA pathway report with predicate devices for product code LZB
- Run a recall and safety report across every LZB manufacturer
- Watch product code LZB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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