21 CFR § 880.6025 - Absorbent tipped applicator.

---
identifier: "/us/cfr/t21/s880.6025"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 880.6025 - Absorbent tipped applicator."
title_number: 21
title_name: "Food and Drugs"
section_number: "880.6025"
section_name: "Absorbent tipped applicator."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "880"
part_name: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 69682, Oct. 21, 1980, unless otherwise noted."
cfr_part: "880"
---


# 880.6025 Absorbent tipped applicator.

(a) *Identification.* An absorbent tipped applicator is a device intended for medical purposes that consists 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.

(b) *Classification.* Class I (general controls). 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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001; 90 FR 55987, Dec. 4, 2025]