Attachment C Gloves .docx

70FA2020R00000011 Attachment C – Gloves Background

The mission of the Division of Strategic National Stockpile (DSNS), of the United States (U.S.) Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), is to ensure the availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of biological, chemical, radiological, natural disasters or other emerging infectious disease agents. When state, local, tribal, and territorial public health and medical systems request federal assistance to support their response efforts, DSNS ensures that the right medicines and supplies get to those who need them most during a public health emergency or pandemic event.

The Strategic National Stockpile (SNS) is a national repository of pharmaceuticals, vaccines, medical supplies, and medical equipment stored in strategic locations around the nation. These assets are designed to supplement state and local public health departments in the event of a large-scale public health emergency that causes local supplies to run out.

Protection of healthcare workers and first responders from transmission of pathogens is essential to maintaining resilience of the U.S. healthcare system. Non-Sterile, Powder-Free, Patient Examination Gloves are one part of an infection control strategy and are examples of personal protective equipment (PPE) that is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. The appropriate use of PPE is an important component of the overall strategy of certain infection control guidelines.

Purpose

The U.S. Government is interested in establishing multiple awards for immediate purchases of Non-Sterile, Powder-Free, Patient Examination Gloves used in healthcare settings as described below. This will enable the United States to ensure sufficient availability of such items during national emergencies and/or pandemic events. The Government is concerned about the risks of disruption of any manufacturing facilities or supply chains located outside of the United States. Thus, offerors are advised to pay special attention to the instructions regarding manufacturing capability and/or supply chains located outside of the United States as well as the evaluation criteria related to manufacturing capability and foreign supply chains. The Government is concerned about the risks related to excessive pricing of critical PPE and intends only to acquire PPE at prices that it can determine are fair and reasonable. Thus, offerors are advised to pay special attention to the instructions regarding pricing.

The following is a list to provide clarification about the different types of acceptable Non-Sterile, Powder-Free, Patient Examination Gloves to protect against contamination that may be proposed as part of the requirement:

Patient Examination gloves are examples of personal protective equipment that are used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations. Patient examination gloves are reviewed and cleared by the Federal and Drug Administration (FDA) as Class I reserved medical devices that requires a 510(k) premarket notification requiring registration and listing, under 21 CFR 880.6250.

a) Nitrile, Latex, Vinyl (PVC), or Polymer other than Vinyl patient examination gloves

b) Length requirements for patient examination gloves must be a minimum of 220mm-230mm (8.6”- 9”) depending on glove size and material type

c) Glove thickness for patient examination gloves must be a minimum of 8 mils

d) Tensile strength as identified in relevant American Society for Testing and Materials (ASTM) standards

e) Minimum unaged elongation percent as identified in relevant ASTM standards

f) Acceptable Quality Level (AQL) for holes in MPa as identified in relevant ASTM standards

Scope of Work

The Contractor, as an independent organization and not as an agent of the Government, shall furnish all labor, materials, supplies, facilities, equipment, transportation and travel necessary to deliver one or more of the following acceptable Non-Sterile, Powder-Free, Patient Examination Gloves. Preference will be given in order by:

· Nitrile, Non-Sterile, Powder-Free, Patient Examination Gloves

· Must meet ASTM D6319-19 standard specifications

· Must be registered and listed with FDA

· Must be snug or form fitting patient examination gloves

· Equivalent or similar to Dynarex #2513

· Extra Small, Small, Medium, Large, Extra Large

· Latex, Non-Sterile, Powder-Free, Patient Examination Gloves

· Must meet ASTM D3578-19 standard specifications

· Must be registered and listed with FDA

· Must be snug or form fitting patient examination gloves

· Equivalent or similar to Medline #CUR8106

· Extra Small, Small, Medium, Large, Extra Large

· Non-Latex, Non-Sterile, Powder-Free, Patient Examination Gloves (PVC/Polychloroprene)

· Must meet ASTM D5250-19 standard specifications (for Poly (vinyl chloride) or ASTM D6977 standard specifications (for polychloroprene)

· Must be registered and listed with FDA

· Must be snug or form fitting patient examination gloves

· Equivalent or similar to Innovative Healthcare #161300 or Smart Practice #433467

· Extra Small, Small, Medium, Large, Extra Large A combination of the gloves described above may be acceptable to meet the Government’s requirement.

Declaration of conformity to applicable standards listed above must be provided.

Product manufacturer and part number, description, and literature must be included in the proposal for consideration.