federal_register: 99-19192

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
99-19192 Medical Gloves; Draft Guidance Manual; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Glove Guidance Manual.'' The draft guidance represents a major revision of this guidance document, which was initially issued in 1993 under the title ``Guidance for Medical Gloves: A Workshop Manual.'' This draft guidance is intended to provide current information to assist manufacturers and others in obtaining marketing clearance, applying manufacturing and design controls, and properly labeling medical gloves. This draft guidance also includes recommendations for limits on the amounts of glove powder and natural latex protein present on surgeon's and patient examination gloves. Elsewhere in this issue of the Federal Register, the FDA is proposing reclassification of surgeon's gloves and patient examination gloves into class II (special controls) because the agency believes that special controls are necessary to provide reasonable assurance of the safety and effectiveness of the gloves. The agency is proposing that the draft guidance ``Medical Glove Guidance Manual'' be one of the special controls, and the agency is requesting comment on the content of the manual at this time. 1999-07-30 1999 7 https://www.federalregister.gov/documents/1999/07/30/99-19192/medical-gloves-draft-guidance-manual-availability https://www.govinfo.gov/content/pkg/FR-1999-07-30/pdf/99-19192.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Glove Guidance Manual.'' The draft guidance represents a major revision of this guidance document, which was initially issued in 1993 under...

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