{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled \"Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.\" FDA is issuing this draft guidance to describe the Agency's premarket regulatory requirements and the performance testing needed to support liquid barrier claims for gowns intended for use in health care settings. This draft guidance is being issued in light of the public health importance of personal protective equipment in health care settings and the recognition that terminology used to describe gowns has evolved, including by industry, the standards community, and health care professionals. This draft guidance is not final nor is it in effect at this time.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2015/06/30/2015-16011.html","cfr_references":[],"citation":"80 FR 37275","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 31, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-2261"],"dockets":[],"document_number":"2015-16011","effective_on":null,"end_page":37276,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/06/30/2015-16011.xml","html_url":"https://www.federalregister.gov/documents/2015/06/30/2015-16011/premarket-notification-requirements-concerning-gowns-intended-for-use-in-health-care-settings-draft","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-16011?publication_date=2015-06-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-06-30/2015-16011/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":285,"last_updated":"2026-07-27 10:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-06-30/pdf/2015-16011.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-16011.pdf?1435581993","publication_date":"2015-06-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/06/30/2015-16011.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-D-2261","supporting_documents_count":null,"docket_id":"FDA-2015-D-2261","regulation_id_number":null,"title":"Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings","checked_regulationsdotgov_at":"2015-09-01T05:00:40Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":37275,"subtype":null,"title":"Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}