21 CFR 878.4450
§ 878.4450 Nonabsorbable gauze for internal use.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 878.4450, § 878.4450 Nonabsorbable gauze for internal use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90430
- Permanent ID
ys:prov:90430@1- SHA-256
da50303278791c154bbd22f78234847a3a318cde55360fbfff1ac3909fa5dc67
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Full text
(a) Identification. Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements.
(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 § 878.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.