Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential

K230079 · Ansell Healthcare Products, LLC · KGO · Aug 23, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230079
• Device Name: Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential
• Applicant: Ansell Healthcare Products, LLC
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Aug 23, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

These surgical gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with chemotherapy drugs, have low dermatitis potential, and are nonpyrogenic. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Sterile, disposable synthetic polyisoprene surgical gloves; polyurethane inner coating for donning. Used by operating room personnel to protect surgical wounds from contamination. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Provides barrier protection; reduces risk of dermatitis. Not for use with Carmustine or Thiotepa due to low permeation times.

Clinical Evidence

Clinical testing performed using Modified Draize-95 Test per FDA 1999 guidance. Study evaluated inner and outer surfaces for skin sensitization. Results demonstrated low dermatitis potential in human subjects. Non-clinical testing included ASTM D3577 (physical properties), ASTM D6978-05 (chemotherapy permeation), and ISO 10993 series (biocompatibility).

Technological Characteristics

Synthetic polyisoprene rubber; polyurethane polymer inner coating. Hand-specific, beaded cuff, powder-free. Sterilized via irradiation (10^-6 SAL). Meets ASTM D3577, ASTM D5151, ASTM D6124. Biocompatibility per ISO 10993-5, 10, 11.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination. Suitable for use with chemotherapy drugs and individuals requiring low dermatitis potential gloves.

Regulatory Classification

Identification

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. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Gammex Non-Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs (K190018)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 23, 2023

Ansell Healthcare Products, LLC. Don Cronk Director, Regulatory Affairs for the Americas 2301 Robb Drive Reno, Nevada 89523

Re: K230079

Trade/Device Name: Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC, OPJ Dated: July 20, 2023 Received: July 24, 2023

Dear Don Cronk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Bifeng Qian -S

BiFeng Qian, M.D., Ph.D Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K230079

#### Device Name

Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential

#### Indications for Use (Describe)

These surgical gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with chemotherapy drugs, have low dermatitis potential, and are nonpyrogenic. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Tested chemotherapy drugs are as follows:

| Test Chemotherapy drug & Concentration | Breakthrough Detection Time (Minutes) |
|-----------------------------------------|---------------------------------------|
| Bleomycin (15 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carmustine (BCNU) (3.3 mg/ml) | 12.6 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Daunorubicin (5 mg/ml) | >240 |
| Docetaxel (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (Toposar) (20.0 mg/ml) | >240 |
| Fludarabine (25 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Gemcitabine (Gemzar) (38 mg/ml) | >240 |
| Idarubicin (1 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Irinotecan (20.0 mg/ml) | >240 |
| Mechlorethamine HCI (1.0 mg/ml) | >240 |
| Melphalan (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Oxaliplatin (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Paraplatin (10 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 26.6 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Ellence (2 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 12.6 minutes and Thiotepa: 26.6 minutes. Warning Do not use with Carmustine and Thiotepa

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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510K Summary

K230079 Submitter: Ansell Healthcare Products LLC. 2301 Robb Drive Reno, NV 89523 USA

#### Contact Person(s):

Don Cronk Assoc. Director, Regulatory Phone: [phone] [e-mail]

Carson Delaloye Sr. Administrator, Quality Phone: [phone] [e-mail]

#### Date Prepared: August 23, 2023

#### Name of Device

| Trade Names: | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs<br>and Low Dermatitis Potential |
|----------------------------|-----------------------------------------------------------------------------------------------------|
| Common Name: | Surgeon's Gloves |
| Classification Name: | Non-Powdered Surgeon's Glove |
| Classification Regulation: | 21 CFR 878.4460 |
| Device Class: Product | I |
| Code: Classification | KGO, LZC, OPJ |
| Panel: 510k Number | General and Plastic Surgery |
| Assigned: | K230079 |

#### Legally Marketed Predicate Device

K190018-Gammex Non-Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs

#### Device Description

Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber, are white in color, and are available in sizes 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy.

#### Indication for Use Statement

These surgical gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with chemotherapy drugs, have low dermatitis potential, and are non-pyrogenic. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 12.6 minutes and Thiotepa: 26.6 minutes. Warning Do not use with Carmustine and Thiotepa.

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## Chemotherapy Drug Permeation

(Minimum breakthrough detection time in minutes) (ASTM D6978-05 2019)

| TEST CHEMOTHERAPY DRUG AND<br>CONCENTRATION | MINIMUM<br>BREAKTHROUGH<br>TIME (Minutes) |
|---------------------------------------------|-------------------------------------------|
| Blenoxane (15 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carmustine (BCNU) (3.3 mg/ml) | 12.6 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Daunorubicin (5 mg/ml) | >240 |
| Docetaxel (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (Toposar) (20.0 mg/ml) | >240 |
| Fludarabine (25 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Gemcitabine (Gemzar) (38<br>mg/ml) | >240 |
| Idarubicin (1 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Irinotecan (20.0 mg/ml) | >240 |
| Mechlorethamine HCI (1.0 mg/ml) | >240 |
| Melphalan (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Oxaliplatin (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Paraplatin (10 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 26.6 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Ellence (2 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |

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| | Technical Characteristic Comparison Table | | | | |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------|
| | Predicate Device | | Subject Device | Comparison | |
| Trade Name | Gammex Non-Latex PI White<br>Polyisoprene Surgical Gloves Tested for<br>Use with Chemotherapy Drugs | | Polyisoprene Surgical Glove Tested<br>for Use with Chemotherapy Drugs and<br>Low Dermatitis Potential | Different | |
| 510(k) Number | K190018 | | K230079 | Different | |
| Submitter | Ansell Healthcare Products LLC | | Ansell Healthcare Products LLC | Same | |
| Product Code | KGO | | KGO, LZC, OPJ | Same | |
| Regulation<br>Number | 21 CFR 878.4460 | | 21 CFR 878.4460 | Same | |
| Regulation<br>Name | Non-powdered Surgeon's glove | | Non-powdered Surgeon's glove | Same | |
| Indications<br>for Use | Gammex Non-Latex PI White Surgical Gloves Tested<br>for Use with Chemotherapy Drugs are intended to be<br>worn by operating room personnel to protect a<br>surgical wound from contamination. These gloves<br>were tested for use with Chemotherapy Drugs as per<br>ASTM D6978-05 Standard Practice for Assessment of<br>Medical Gloves to Permeation by Chemotherapy<br>Drugs. | | These surgical gloves are intended to be worn by<br>operating room personnel to protect a surgical wound<br>from contamination. These gloves were tested for use<br>with chemotherapy drugs, have low dermatitis<br>potential, and are non-pyrogenic. These gloves were<br>tested for use with Chemotherapy Drugs as per ASTM<br>D6978-05 Standard Practice for Assessment of Medical<br>Gloves to Permeation by Chemotherapy Drugs. | Similar | |
| | Tested chemotherapy drugs are as follows:<br>TESTCHEMOTHERAPY<br>DRUGAND<br>CONCENTRATION | MINIMUM<br>BREAKTHROUGH<br>DETECTION<br>TIME (Minutes) | TEST CHEMOTHERAPY<br>DRUGAND<br>CONCENTRATION | MINIMUM<br>BREAKTHROUGH<br>TIME (Minutes) | |
| | Blenoxane (15<br>mg/ml) | >240 | Blenoxane (15<br>mg/ml) | >240 | |
| | Busulfan (6 mg/ml) | >240 | Busulfan (6 mg/ml) | >240 | |
| | Carmustine(BCNU)<br>(3.3 mg/ml) | 10.2 | Carmustine (BCNU)<br>(3.3 mg/ml) | 12.6 | |
| | Cisplatin (1.0 mg/ml) | >240 | Cisplatin (1.0 mg/ml) | >240 | |
| | Cyclophosphamide<br>(Cytoxan) (20.0<br>mg/ml) | >240 | Cyclophosphamide<br>(Cytoxan) (20.0<br>mg/ml) | >240 | |
| | Cytarabine (100<br>mg/ml) | >240 | Cytarabine (100<br>mg/ml) | >240 | |
| | Dacarbazine (DTIC)<br>(10.0 mg/ml) | >240 | Dacarbazine (DTIC)<br>(10.0 mg/ml) | >240 | |
| | Daunorubicin (5<br>mg/ml) | >240 | Daunorubicin (5<br>mg/ml) | >240 | |
| | Docetaxel (10.0<br>mg/ml) | >240 | Docetaxel (10.0<br>mg/ml) | >240 | |
| | Doxorubicin<br>Hydrochloride (2.0<br>mg/ml) | >240 | Doxorubicin<br>Hydrochloride (2.0<br>mg/ml) | >240 | |
| | Etoposide (Toposar)<br>(20.0 mg/ml) | >240 | Etoposide (Toposar)<br>(20.0 mg/ml) | >240 | |
| | Fludarabine (25<br>mg/ml) | >240 | Fludarabine (25<br>mg/ml) | >240 | |
| | Fluorouracil (50.0<br>mg/ml) | >240 | Fluorouracil (50.0<br>mg/ml) | >240 | |
| | Gemcitabine<br>(Gemzar) (38 mg/ml) | >240 | Gemcitabine<br>(Gemzar) (38 mg/ml) | >240 | |
| | Idarubicin (1 mg/ml) | >240 | Idarubicin (1 mg/ml) | >240 | |
| | Ifosfamide (50.0<br>mg/ml) | >240 | Ifosfamide (50.0<br>mg/ml) | >240 | |
| | Irinotecan (20.0<br>mg/ml) | >240 | Irinotecan (20.0<br>mg/ml) | >240 | |
| | Mechlorethamine HCI<br>(1.0 mg/ml) | >240 | Mechlorethamine HCI<br>(1.0 mg/ml) | >240 | |
| | Melphalan (5 mg/ml) | >240 | Melphalan (5 mg/ml) | >240 | |
| | Methotrexate (25<br>mg/ml) | >240 | Methotrexate (25<br>mg/ml) | >240 | |
| | Mitomycin C (0.5<br>mg/ml) | >240 | Mitomycin C (0.5<br>mg/ml) | >240 | |
| | Mitoxantrone (2.0<br>mg/ml) | >240 | Mitoxantrone (2.0<br>mg/ml) | >240 | |
| | Oxaliplatin (2.0<br>mg/ml) | >240 | Oxaliplatin (2.0<br>mg/ml) | >240 | |
| | Paclitaxel (Taxol) (6.0<br>mg/ml) | >240 | Paclitaxel (Taxol) (6.0<br>mg/ml) | >240 | |
| | Paraplatin (10 mg/ml) | >240 | Paraplatin (10 mg/ml) | >240 | |
| | Thiotepa (10.0 mg/ml) | 11.5 | Thiotepa (10.0 mg/ml) | 26.6 | |
| | Vincristine Sulfate (1.0<br>mg/ml) | >240 | Vincristine Sulfate (1.0<br>mg/ml) | >240 | |
| | Ellence (2 mg/ml) | >240 | Ellence (2 mg/ml) | >240 | |
| | Rituximab (10 mg/ml) | >240 | Rituximab (10 mg/ml) | >240 | |
| | Please note that the following drugs have<br>extremely low permeation times:<br>Carmustine (BCNU) 10.2 minutes and<br>Thiotepa: 11.5 minutes. Warning Do not<br>use with Carmustine and Thiotepa | | Please note that the following drugs have<br>extremely low permeation times:<br>Carmustine (BCNU) 12.6 minutes and<br>Thiotepa: 26.6 minutes. Warning Do not<br>use with Carmustine and Thiotepa | | |
| Prescription<br>or Over-<br>The<br>Counter-<br>Use | Over-The-Counter-Use | | Over-The-Counter-Use | | Same |
| Materials | Synthetic polyisoprene rubber | | Synthetic polyisoprene rubber | | Same |
| Coating | Polyurethane polymer inner coating to<br>aid donning | | Polyurethane polymer inner coating to<br>aid donning | | Same |
| Design | Single use | | Single use | | Same |
| | Powder-free | | Powder-free | | Same |
| | Hand Specific | | Hand Specific | | Same |
| | Beaded cuff | | Beaded cuff | | Same |
| Color | White | | White | | Same |
| Sizes | 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 | | 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 | | Same |
| Dimensions and<br>physical<br>properties | Meets ASTM D3577 | | Meets ASTM D3577 | | Same |
| Sterility | Sterile | | Sterile | | Same |
| Sterilization<br>method | Irradiation | | Irradiation | | Same |

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| Sterility<br>Assurance Level<br>(SAL) | 10-6 SAL | 10-6 SAL | Same |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------|
| Freedom from<br>holes | Meets ASTM D3577-<br>09(2015)<br>Inspection level/AQL: GI/AQL 1.5 | Meets ASTM D3577-<br>09(2015)<br>Inspection level/AQL: GI/AQL 1.5 | Similar |
| Powder-Free | Meets ASTM D 6124-06. Meets<br>Applicable Definition for Powder Free; ≤ 2<br>mg per glove | Meets ASTM D 6124-06. Meets<br>Applicable Definition for Powder Free; ≤ 2 mg per glove | Same |
| Protein Content | Not Applicable | Not Applicable | Same |
| In Vitro<br>Cytotoxicity | Failed. Cytotoxicity Grade 4. | Failed. Cytotoxicity Grade 4. | Same |
| Biocompatibility<br>Primary Skin<br>Irritation<br>ISO 10993-<br>10:2010 | Under the conditions of the study (per<br>ISO 10993-10), the device is not an<br>irritant | Under the conditions of the study (per<br>ISO 10993-10), the device is not an<br>irritant | Same |
| Biocompatibility<br>Dermal<br>Sensitization -<br>ISO 10993-<br>10:2010 | Under the conditions of the study<br>(per ISO 10993-10), not a sensitizer | Under the conditions of the study<br>(per ISO 10993-10), not a sensitizer | Same |
| Biocompatibility<br>Acute Systemic<br>Toxicity - ISO<br>10993-11: 2006 | Under the conditions of the study, there<br>was no mortality or evidence of acute<br>systemic toxicity | Under the conditions of the study,<br>there was no mortality or evidence<br>of acute systemic toxicity | Same |
| Material-<br>Mediated<br>Pyrogenicity | No pyrogenicity claims made | Under the conditions of the study,<br>both inner and outer surface is<br>non-pyrogenic | Different |
| Bacterial<br>Endotoxin | No endotoxin claims | Under the conditions of the study,<br>test results indicate low endotoxin<br>level | Different |
| Low Dermatitis<br>Potential | No low dermatitis potential claims made | Under the conditions of the study,<br>the test results demonstrated low<br>dermatitis potential for the subject<br>glove. | Different |

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The subject device is manufactured from synthetic polyisoprene rubber with polyurethane polymer inner coating to aid donning. The predicate device is manufactured from synthetic polyisoprene rubber with polyurethane polymer inner coating to aid donning.

The subject device meets the applicable requirements for surgeon's gloves with regards to dimensions and sizes, physical properties, freedom from holes, and powder residues, as found in the following standards: ASTM D3577, ASTM D5151 and ASTM D6124. The subject device passes biological reactivity testing for dermal sensitization, acute systemic toxicity, and material-mediated pyrogenicity in accord with the ISO 10993-10 and ISO 10993-11.

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## Summary of Non-clinical Testing

| Technological<br>Characteristics | Purpose | Standard/Test/FDA Guidance<br>Criteria | Result Summary |
|-----------------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions | To evaluate the<br>dimension of the glove | ASTM D3577<br>Meets ASTM D3577 requirements<br>for length, width and thickness | Pass |
| Length | | Minimum 265mm | Pass |
| Palm Width (size) | | (mm) | Pass |
| 5.5 | | 70±6 | Pass |
| 6.0 | | 76±6 | Pass |
| 6.5 | | 83±6 | Pass |
| 7.0 | | 89±6 | Pass |
| 7.5 | | 95±6 | Pass |
| 8.0 | | 102±6 | Pass |
| 8.5 | | 108±6 | Pass |
| 9.0 | | 114±6 | Pass |
| Thickness | To evaluate the thickness<br>of the glove | (mm)…