US-FDA Classification for Medical Swabs. It is An absorbent tipped applicator is a device intended for medical purposes that consist of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.
The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
| Classification Name | APPLICATOR, ABSORBENT TIPPED, STERILE |
|---|---|
| Device | Applicator, Absorbent Tipped, Sterile |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Product Code | KXG |
| Premarket Review | Drug Delivery and General Hospital Devices, and Human Factors (DHT3C) |
| Submission Type | 510(K) Exempt |
| Regulation Number | 880.6025 |
| Device Class | 1 |
| Total Product Life Cycle (TPLC) | TPLC Product Code Report |
| GMP Exempt? | No |
| Summary Malfunction Reporting | Eligible |
US-FDA Classification for Medical Swabs, Code of Federal Regulations Title 21
