Inactive Service-Disabled Veteran-Owned Small Business (SDVOSB) Sole Source (FAR 19.14)

Salient Characteristics Sterile Surgical (aka Surgeon s) Gloves Listed for use in surgical environments (sterile) Sterile, powder free, surgical gloves A non-powdered surgeon's glove is a device inten... Salient Characteristics Sterile Surgical (aka Surgeon s) Gloves Listed for use in surgical environments (sterile) Sterile, powder free, surgical gloves A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. Compatible color indicator underglove available to prevent needlestick injury 12 length minimum Thickness preferred: 9.4mil at the finger Cuff preferred: Beaded Finish preferred: micro-roughened surface Latex-free preferred Sterility: Statessterilization method (radiation, EtOH gas, etc.) used Sterilization meets specification of 21 CFR 801.150(e). Sterility Assurance Level (SAL) should be 10-6 or better for sterile gloves References for standards: ANSI/AAMI/ISO 11135- Medical devices - Validation and routine control of ethylene oxide sterilization AAMI/CDV 11137 Sterilization of health care products Radiation AAMI/ISO Technical Information Report (TIR) 13409 Sterilization of health care products - Radiation sterilization AQL = 0.65 (Natural Rubber Latex, or NRL) or 1.0 (Non-Latex) The lower the AQL, the better 0.65 is preferred for VA Boston Meets FDA, ASTM, EN and ISO quality standards Must be FDA registered (Class IIa medical device) (21CFR800.20) Look up at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm ASTM glove standards (based on material) Nitrile glove standards ASTM D6319-19 compliant = Standard specification for Nitrile Examination Gloves for medical applications. Composed of testing: D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTension D573 Test Method for Rubber Deterioration in an Air Oven D3578 Specification for Rubber Examination Gloves D3767 Practice for Rubber--Measurement of Dimensions D5151 Test Method for Detection of Holes in Medical Gloves = 1.0 AQL required (0.65 preferred) D6124 Test Method for Residual Powder on Medical Gloves = max 2mg per glove Test D1671 Blood borne Pathogen test = must pass Test D6319 tensile strength of at least 18MPa, and minimum of 500% elongation Latex gloves standards ASTM D3577-19 compliant = Standard specification for Rubber Surgical Gloves Composed of testing: D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTension D573 Test Method for RubberDeterioration in an Air Oven D3767 Practice for Rubber--Measurement of Dimensions D5151 Test Method for Detection of Holes in Medical Gloves = 1.0 AQL required (0.65 preferred) D5712 Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method = less than 50mcg protein per glove D6124 Test Method for Residual Powder on Medical Gloves D6499 Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products Test D3578 (instead of D6319) Medical grade Latex = tensile strength of 18MPa and minimum elongation of 700% ISO standards ISO 10282:2014 Single-use sterile surgical rubber gloves Type 1 natural rubber latex Type 2 nitrile, polychloroprene, styrene butadiene rubber solution, styrene butadiene rubber emulsion or thermoplastic elastomer solution. EN 455 EN 455 Part 1: 2002- Requirements and testing for freedom from holes. This standard specifies requirements and gives the test method for single use medical gloves in order to determine freedom from holes. The compliance level for freedom from holes shall be an AQL of 1.5. EN 455 Part 2: 2011 Requirements and testing for physical properties. This standard specifies requirements and gives test methods for physical properties of single use medical gloves in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user. EN 455 Part 3: 2006 Requirements and testing for biological evaluation. This standard specifies requirements for the evaluation of biological safety for single use medical gloves. It gives requirements for labelling and disclosure of information relevant to the test methods used. EN 455 Part 4: 2009 Requirements and testing for shelf life determination. This standard specifies requirements for shelf life for medical gloves for single use. It also specifies the requirements for labelling and the disclosure of information relevant to the test methods use Only buy from reputable suppliers who hold an internationally recognized quality manufacturing designation such as ISO 13485 Pre- Approved Known products that meet the above requirements: Item Description & size Part number Manufacturer Type Qty per box Boxes per case GLOVE - SURGICAL 5.5 71-41155 BOSMA Biogel PI UltraTouch 50 pairs 4 GLOVE - SURGICAL 6 71-41160 BOSMA Biogel PI UltraTouch 50 pairs 4 GLOVE - SURGICAL 6.5 71-41165 BOSMA Biogel PI UltraTouch 50 pairs 4 GLOVE - SURGICAL 7 71-41170 BOSMA Biogel PI UltraTouch 50 pairs 4 GLOVE - SURGICAL 7.5 71-41175 BOSMA Biogel PI UltraTouch 50 pairs 4 GLOVE - SURGICAL 8 71-41180 BOSMA Biogel PI UltraTouch 50 pairs 4 GLOVE - SURGICAL 8.5 71-41185 BOSMA Biogel PI UltraTouch 50 pairs 4 GLOVE - SURGICAL 9 71-41190 BOSMA Biogel PI UltraTouch 50 pairs 4 GLOVE - UNDERGLOVE 6 71-41660 BOSMA Biogel PI Indicator Underglove 50 pairs 4 GLOVE - UNDERGLOVE 6.5 71-41665 BOSMA Biogel PI Indicator Underglove 50 pairs 4 GLOVE - UNDERGLOVE 7 71-41670 BOSMA Biogel PI Indicator Underglove 50 pairs 4 GLOVE - UNDERGLOVE 7.5 71-41675 BOSMA Biogel PI Indicator Underglove 50 pairs 4 GLOVE - UNDERGLOVE 8 71-41680 BOSMA Biogel PI Indicator Underglove 50 pairs 4 GLOVE - UNDERGLOVE 8.5 71-41685 BOSMA Biogel PI Indicator Underglove 50 pairs 4 GLOVE - UNDERGLOVE 9 71-41690 BOSMA Biogel PI Indicator Underglove 50 pairs 4 *Bosma repackages gloves made by Molnlycke. Molnlycke branded gloves also approved. Item Description & size Part number Manufacturer Type Qty per box Boxes per case GLOVE - SURGICAL 5.5 MSG1055 or BOS1MSG1055 Medline SensiCare Surgical Gloves with Aloe 25 pairs 100 GLOVE - SURGICAL 6 MSG1060 or BOS1MSG1060 Medline SensiCare Surgical Gloves with Aloe by Bosma 25 pairs 100 GLOVE - SURGICAL 6.5 MSG1065 or BOS1MSG1065 Medline SensiCare Surgical Gloves with Aloe by Bosma 25 pairs 100 GLOVE - SURGICAL 7 MSG1070 or BOS1MSG1070 Medline SensiCare Surgical Gloves with Aloe by Bosma 25 pairs 100 GLOVE - SURGICAL 7.5 MSG1075 or BOS1MSG1075 Medline SensiCare Surgical Gloves with Aloe by Bosma 25 pairs 100 GLOVE - SURGICAL 8 MSG1080 or BOS1MSG1080 Medline SensiCare Surgical Gloves with Aloe by Bosma 25 pairs 100 GLOVE - SURGICAL 8.5 MSG1085 or BOS1MSG1085 Medline SensiCare Surgical Gloves with Aloe by Bosma 25 pairs 100 GLOVE - SURGICAL 9 MSG1090 or BOS1MSG1090 Medline SensiCare Surgical Gloves with Aloe by Bosma 25 pairs 100 GLOVE - UNDERGLOVE 6 MSG1260 or BOS71MSG1260 Medline SensiCare Green Gloves with Aloe 25 pairs 100 GLOVE - UNDERGLOVE 6.5 MSG1265 or BOS71MSG1265 Medline SensiCare Green Gloves with Aloe 25 pairs 100 GLOVE - UNDERGLOVE 7 MSG1270 or BOS71MSG1270 Medline SensiCare Green Gloves with Aloe 25 pairs 100 GLOVE - UNDERGLOVE 7.5 MSG1275 or BOS71MSG1275 Medline SensiCare Green Gloves with Aloe 25 pairs 100 GLOVE - UNDERGLOVE 8 MSG1280 or BOS71MSG1280 Medline SensiCare Green Gloves with Aloe 25 pairs 100 GLOVE - UNDERGLOVE 8.5 MSG1285 or BOS71MSG1285 Medline SensiCare Green Gloves with Aloe 25 pairs 100 GLOVE - UNDERGLOVE 9 MSG1290 or BOS71MSG1290 Medline SensiCare Green Gloves with Aloe 25 pairs 100 Salient Characteristics Medical Exam Gloves Non-Chemo Applications This is a repetitive requirement for VA Boston Healthcare System. Latex Free Powder Free Nitrile Ambidextrous Full Textured Any Color Thickness Minimum 3.0 mil Palm 4.0 Finger Length 9.5 Maximum FDA approved Medical Use Non-chemo Applications Minimum (Chemo Application gloves are acceptable) Boxed with <=200 Each per box Gloves identified that meet these minimum characteristics: Manufacturer Product Name Product # Size EA per BX BX per CS Bosma Aloe Touch Ice 73-20300 XS 200 10 Bosma Aloe Touch Ice 73-20301 S 200 10 Bosma Aloe Touch Ice 73-20302 M 200 10 Bosma Aloe Touch Ice 73-20303 L 200 10 Bosma Aloe Touch Ice 73-20304 XL 200 10 Bosma Aloe Touch 73-20100 XS 100 10 Bosma Aloe Touch 73-20101 S 100 10 Bosma Aloe Touch 73-20102 M 100 10 Bosma Aloe Touch 73-20103 L 100 10 Bosma Aloe Touch 73-20104 XL 100 10 Bosma Nitrile Textured 72-10500 XS 100 10 Bosma Nitrile Textured 72-10501 S 100 10 Bosma Nitrile Textured 72-10502 M 100 10 Bosma Nitrile Textured 72-10503 L 100 10 Bosma Nitrile Textured 72-10504 XL 100 10 Smart Practice Reflection 43308 S 100 10 Smart Practice Reflection 43309 M 100 10 Smart Practice Reflection 43310 L 100 10 Smart Practice Reflection 43311 XL 100 10 Smart Practice Reflection Sapphire 431107 S 200 12 Smart Practice Reflection Sapphire 431108 M 200 12 Smart Practice Reflection Sapphire 431109 L 200 12 Smart Practice Reflection Sapphire 431110 XL 200 12 Smart Practice Dexterity 433201 S 100 10 Smart Practice Dexterity 433202 M 100 10 Smart Practice Dexterity 433203 L 100 10 Smart Practice Dexterity 433204 XL 100 10 Kimberly Clark Nitrile 55081 S 100 10 Kimberly Clark Nitrile 55082 M 100 10 Kimberly Clark Nitrile 55083 L 100 10 Kimberly Clark Nitrile 55084 XL 90 10 Dynarx Safe Touch 2511 S 100 10 Dynarx Safe Touch 2511 M 100 10 Dynarx Safe Touch 2511 L 100 10 Dynarx Safe Touch 2511 XL 100 10 Equivalent gloves to the above that meet all requirements of the salient characteristics will be reviewed by subject matter experts at the facility, samples are requested for equivalents and can be sent to: VA Boston Healthcare System 1400 VFW PKWY Building #7 Warehouse Attn: Melissa Williams West Roxbury, MA 02132 Quantity Needed: Small 500,000 EACH Medium 800,000 EACH Large 500,000 EACH Extra Large 500,000 EACH Please deliver to address below VA Boston Healthcare System 940 Belmont Street Warehouse Brockton, MA 02301