Att A Salient Characteristics -Sterile Surgical Gloves.pdf

Salient Characteristics – Sterile Surgical (aka Surgeon’s) Gloves o Listed for use in surgical environments (sterile) o Sterile, powder free, surgical gloves o 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.

o Compatible color indicator underglove available o to prevent needlestick injury o 12” length minimum o Thickness preferred: 9.4mil at the finger o Cuff preferred: Beaded o Finish preferred: micro-roughened surface o Latex-free preferred o Sterility: States sterilization method (radiation, EtOH gas, etc.) used o 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 o AQL = 0.65 (Natural Rubber Latex, or NRL) or 1.0 (Non-Latex) o The lower the AQL, the better o 0.65 is preferred for VA Boston o Meets FDA, ASTM, EN and ISO quality standards o Must be FDA registered (Class IIa medical device) – (21CFR800.20) o Look up at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm o ASTM glove standards (based on material) o 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 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm javascript:goRefDoc('D412') javascript:goRefDoc('D573') javascript:goRefDoc('D3578') javascript:goRefDoc('D3767') o Latex gloves standards

ASTM D3577-19 compliant = Standard specification for Rubber Surgical Gloves

• Composed of testing:

o D412 Test Methods for Vulcanized Rubber and Thermoplastic

ElastomersTension o D573 Test Method for RubberDeterioration in an Air Oven o D3767 Practice for Rubber--Measurement of Dimensions o D5151 Test Method for Detection of Holes in Medical Gloves = 1.0

AQL required (0.65 preferred) o 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 o D6124 Test Method for Residual Powder on Medical Gloves o D6499 Test Method for Immunological Measurement of Antigenic

Protein in Hevea Natural Rubber (HNR) and its Products o Test D3578 (instead of D6319)– Medical grade Latex = tensile strength of 18MPa and minimum elongation of 700% o ISO standards – ISO 10282:2014 – Single-use sterile surgical rubber gloves o Type 1 – natural rubber latex o Type 2 – nitrile, polychloroprene, styrene–butadiene rubber solution, styrene– butadiene rubber emulsion or thermoplastic elastomer solution.

o EN 455 o 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.

o 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.

o 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.

o 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 o Only buy from reputable suppliers who hold an internationally recognized quality manufacturing designation such as ISO 13485 javascript:goRefDoc('D412') javascript:goRefDoc('D573') javascript:goRefDoc('D3767') javascript:goRefDoc('D6124') https://www.spservices.co.uk/spdownloads/56fba1e064b23ISO13485Issue6May2016.pdf o 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

GLOVE -

SURGICAL 6 71-41160 BOSMA

Biogel PI UltraTouch 50 pairs

GLOVE -

SURGICAL 6.5 71-41165 BOSMA

Biogel PI UltraTouch 50 pairs

GLOVE -

SURGICAL 7 71-41170 BOSMA

Biogel PI UltraTouch 50 pairs

GLOVE -

SURGICAL 7.5 71-41175 BOSMA

Biogel PI UltraTouch 50 pairs

GLOVE -

SURGICAL 8 71-41180 BOSMA

Biogel PI UltraTouch 50 pairs

GLOVE -

SURGICAL 8.5 71-41185 BOSMA

Biogel PI UltraTouch 50 pairs

GLOVE -

SURGICAL 9 71-41190 BOSMA Biogel PI UltraTouch 50 pairs

GLOVE -

UNDERGLOVE 6 71-41660 BOSMA

Biogel PI Indicator Underglove pairs

GLOVE -

UNDERGLOVE 6.5 71-41665 BOSMA

Biogel PI Indicator Underglove pairs

GLOVE -

UNDERGLOVE 7 71-41670 BOSMA

Biogel PI Indicator Underglove pairs

GLOVE -

UNDERGLOVE 7.5 71-41675 BOSMA

Biogel PI Indicator Underglove pairs

GLOVE -

UNDERGLOVE 8 71-41680 BOSMA

Biogel PI Indicator Underglove pairs

GLOVE -

UNDERGLOVE 8.5 71-41685 BOSMA

Biogel PI Indicator Underglove pairs

GLOVE -

UNDERGLOVE 9 71-41690 BOSMA

Biogel PI Indicator Underglove pairs

*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