{"id":3175,"date":"2025-05-20T20:06:02","date_gmt":"2025-05-20T20:06:02","guid":{"rendered":"https:\/\/veraqueconsulting.com\/cr\/?p=3175"},"modified":"2025-06-30T20:03:17","modified_gmt":"2025-06-30T20:03:17","slug":"classification-and-grouping-of-gloves-in-costa-rica","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/cr\/classification-and-grouping-of-gloves-in-costa-rica\/","title":{"rendered":"Classification and Grouping of Gloves in Costa Rica"},"content":{"rendered":"<p><span data-contrast=\"none\">In our <\/span><a href=\"https:\/\/veraqueconsulting.com\/cr\/guides\/classification-and-grouping-ultimate-guide\/\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">Device Classification and Grouping Guide<\/span><\/b><\/a><span data-contrast=\"none\">, we have explained how to classify and group medical devices in <\/span><b><span data-contrast=\"none\">Costa Rica <\/span><\/b><span data-contrast=\"auto\">based on the <\/span><b><span data-contrast=\"auto\">16 rules<\/span><\/b><span data-contrast=\"auto\"> outlined in Annex A of<\/span> <a href=\"https:\/\/veraqueconsulting.com\/cr\/guides\/ultimate-guide-for-regulatory-affairs-in-costa-rica\/#framework\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">Decree No. 43902-S<\/span><\/b><\/a><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">In addition, we have also explained how to make use of those rules to classify and group specific medical devices such as <\/span><a href=\"https:\/\/veraqueconsulting.com\/cr\/classification-and-grouping-for-surgical-instruments-in-costa-rica\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">surgical instruments<\/span><\/a><span data-contrast=\"none\">,\u00a0 <\/span><a href=\"https:\/\/veraqueconsulting.com\/cr\/classification-and-grouping-for-ultrasound-systems-in-costa-rica\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">ultrasound systems<\/span><\/a><span data-contrast=\"none\">, <\/span><a href=\"https:\/\/veraqueconsulting.com\/cr\/classification-for-in-vitro-diagnostics-in-costa-rica\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">in-vitro diagnostics<\/span><\/a><span data-contrast=\"none\"> and others. In this text we will explain the general characteristics of medical gloves and strategies to classify and group this products in <\/span><b><span data-contrast=\"none\">Costa Rica<\/span><\/b><span data-contrast=\"none\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"none\">\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">General characteristics of medical gloves<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">For healthcare applications, gloves primarily function to prevent cross-contamination between professionals and patients. Specifically, they serve as a barrier that restricts microorganisms present on clinicians&#8217; hands from transferring to patient tissues. Additionally, gloves offer protection to caregivers by reducing their exposure to pathogens originating from patients.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Most gloves for medical use are disposable and can be made from different materials (e.g. latex, nitrile, polyvinyl to neoprene and other polymers). Gloves may come powered (lubricated) with talcum or unpowered corn starch.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">There are two main classifications of gloves for medical use:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"none\">Examination gloves:<\/span><\/b><span data-contrast=\"none\"> also known as inspection gloves, are medical devices made for single use. They are used in medical applications and not medical measures. Additional to preventing cross-contamination they are used to prevent direct contact with substances (chemicals and solutions) with the user\u2019s skin.\u00a0 They can be found sterile or non-sterile.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><b><span data-contrast=\"none\">Surgical gloves <\/span><\/b><span data-contrast=\"none\">come in more precise sizes such as extra-small, extra-large, and other standards to better fit the hands of the user. Surgeons use these types of gloves in surgical procedures, which provide more precision and sensitivity for handling surgical instruments. Surgical gloves are generally sterile.<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3><b><span data-contrast=\"none\">Classification according to the level of risk in Costa Rica<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Both examination and surgical gloves, are considered <\/span><b><span data-contrast=\"none\">Class 2<\/span><\/b><span data-contrast=\"none\">. The material characteristics, powder, sterility, and use do not change this classification of risk.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">Grouping for Sanitary Registration purposes<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Different models of gloves can be included in the same Sanitary Registration in Costa Rica, following these rules:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ol>\n<li data-leveltext=\"%1.\" data-font=\"Montserrat\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">The gloves must belong to the same device classification.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"%1.\" data-font=\"Montserrat\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">The same manufacturer must make the gloves.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"%1.\" data-font=\"Montserrat\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">All models must have the same intended use (surgical or examination gloves) and generic name.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"%1.\" data-font=\"Montserrat\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Differences in terms of properties, size or characteristics that do not significantly modify their indication of use can be grouped.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">If you have additional questions for classifying and grouping your gloves for sale in Costa Rica, please contact us at <\/span><a href=\"mailto:contact@veraqueconsulting.com\"><span data-contrast=\"none\">contact@veraqueconsulting.com<\/span><\/a><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In our Device Classification and Grouping Guide, we have explained how to classify and group medical devices in Costa Rica based on the 16 rules outlined in Annex A of Decree No. 43902-S\u00a0 \u00a0\u00a0 In addition, we have also explained how to make use of those rules to classify and group specific medical devices such [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3176,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[367,386],"tags":[],"class_list":["post-3175","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-classification","category-costa-rica"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Classification and Grouping of Gloves in Costa Rica - Veraque Costa Rica<\/title>\n<meta name=\"description\" content=\"This article provides a review of regulatory standards and classification rules for examination and surgical gloves in Costa Rica.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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