Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)
Device Facts
| Record ID | K220609 |
|---|---|
| Device Name | Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) |
| Applicant | Encompass Industries Sdn. Bhd. |
| Product Code | LZA · General Hospital |
| Decision Date | May 27, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Intended Use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, the glove was tested for chemotherapy drugs permeation.
Device Story
Disposable, non-sterile, powder-free nitrile examination glove; available in white, blue, black, orange, and green. Used by healthcare personnel to prevent cross-contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05. Provides physical barrier protection. Not made with natural rubber latex. Used in clinical settings; operator is healthcare professional or patient (OTC). Output is physical protection; healthcare provider visually inspects glove integrity before use. Benefits include reduced risk of disease transmission and protection from hazardous drug exposure.
Clinical Evidence
No clinical data. Bench testing only, including dimension, freedom from holes (ASTM D5151-19), physical properties (ASTM D412, D573), residual powder (ASTM D6124-06), and chemotherapy drug permeation (ASTM D6978-05). Biocompatibility testing performed per ISO 10993-5, 10, and 11.
Technological Characteristics
Material: Nitrile. Form: Powder-free, non-sterile, disposable. Standards: ASTM D6319-19 (dimensions, physical properties, freedom from holes), ASTM D6978-05 (chemotherapy permeation). Dimensions: 230mm+ length, 0.05mm+ thickness. Biocompatibility: ISO 10993-5, 10, 11. No software or electronic components.
Indications for Use
Indicated for use as a disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner, and to provide protection against exposure to chemotherapy drugs and Fentanyl. Contraindicated for use with Carmustine and ThioTepa.
Regulatory Classification
Identification
A non-powdered patient examination glove 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Predicate Devices
- Black Colored, Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K200181)
Related Devices
- K183287 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate · Kossan International Sdn Bhd · Apr 5, 2019
- K222714 — Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Oct 7, 2022
- K232461 — Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis · Kossan International Sdn Bhd · Nov 14, 2023
- K213408 — BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free · Meditech Gloves Sdn Bhd · Apr 17, 2022
- K244034 — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine · Ever Global (Vietnam) Enterprise Corporation · Feb 6, 2025
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
May 27, 2022
Encompass Industries Sdn. Bhd. Nur Muhyiddin OA Manager Lot 18256, Kawasan Perindustrian Lot Q Kertih BioPolymer Park Kemaman, Terengganu 24300 Malaysia
Re: K220609
Trade/Device Name: Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: February 24, 2022 Received: March 2, 2022
Dear Nur Muhyiddin:
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.
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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian, M.D., Ph.D. Acting 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) K220609
#### Device Name
Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
#### Indications for Use (Describe)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, the glove was tested for chemotherapy drugs permeation.
The following chemotherapy drugs have been tested with the glove:
| Chemotherapy Drugs | Concentration | Breakthrough Detection Time in Minutes | | | | |
|---------------------|---------------|----------------------------------------|------|-------|--------|-------|
| | | White | Blue | Black | Orange | Green |
| Carmustine | 3.3 mg/ml | 11.2 | 10.7 | 11.0 | 67.3 | 67.1 |
| Cisplatin | 1.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Cyclophosphamide | 20.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Dacarbazine | 10.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Doxorubicin HCL | 2.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Etoposide | 20.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Fluorouracil | 50.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Methotrexate | 25.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Paclitaxel | 6.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| ThioTepa | 10.0 mg/ml | 25.2 | 21.5 | 11.1 | 47.8 | 169.1 |
| Mitomycin C | 0.5 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Vincristine Sulfate | 1.0 mg/ml | >240 | >240 | >240 | >240 | >240 |
| Fentanyl Citrate | 100 mcg/2mL | >240 | >240 | >240 | >240 | >240 |
*Please note that the following 2 drugs have extremely low permeation times:
- 1. Carmustine
- 2. Thiotepa
Warning: Do not use with Carmustine and ThioTepa.
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
# K220609
Preparation date: May 27, 2022
| 1. Submitter | | |
|----------------|---|-------------------------------------------------------------------------------------------------------------|
| Name | : | Encompass Industries Sdn. Bhd. |
| Address | : | Lot 18256, Kawasan Perindustrian Lot Q,<br>Kertih Bio-Polymer Park, 24300 Kemaman,<br>Terengganu, Malaysia. |
| Telephone No. | : | +609 831 8866 |
| Contact Person | : | Nur Atikah binti Muhammad Muhyiddin |
| E-mail | : | regulatory@encompass-medical.com atikah@ems-inc.com |
## 2. Identification of Device
| Trade/Proprietary Name(s) | : 1. Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for use with Chemotherapy Drugs and Fentanyl<br>2. Other clients' trade name and private labeling |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name(s) | : Powder-Free Nitrile Examination Glove |
| Classification Name: | : 1. Non-powdered Patient Examination Glove (21 CFR 880.6250)<br>2. Patient Examination Glove, Specialty (Product Code: LZC)<br>3. Polymer Patient Examination Glove (Product Code: LZA) |
| Device Classification | : Class I |
# 3. Identification of Legally Marketed Device as Predicate
| Predicate name | : Black Colored, Powder Free Nitrile Examination Gloves, Non-sterile,<br>Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | : K200181 |
| Company | : Comfort Rubber Glove Industries Sdn Bhd |
## 4. Description of Device
The proposed Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for use with Chemotherapy Drugs and Fentanyl is a disposable device intended for over-the-counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. The patient examination gloves are not made with natural rubber latex. General specifications of the glove are as below:
| 1. Overall Length | : | 230 mm minimum |
|---------------------|---|--------------------------------------|
| 2. Width | : | 95 ± 5 mm minimum (for medium glove) |
| 3. Palm Thickness | : | 0.05 mm minimum |
| 4. Finger Thickness | : | 0.05 mm minimum |
| 5. Tensile Strength | | |
| a. Before Aging | : | 14 MPa minimum |
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| b. After Aging | : | 14 MPa minimum |
|------------------------|---|----------------|
| 6. Ultimate Elongation | | |
| a. Before Aging | : | 500 % minimum |
| b. After Aging | : | 400 % minimum |
| 7. Pinhole AQL | : | 2.5 |
## 5. Intended Use / Indication for Use:
A Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for use with Chemotherapy Drugs and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for chemotherapy drugs permeation test.
Table 5.1 Summary Test Results for Resistance of Powder-Free Nitrile Examination Gloves (White, Blue, Black, Orange and Green Color) to Permeation by Chemotherapy Drugs
| Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time (minutes) | | | | |
|---------------------------------------------------------------------------|---------------|-----------------------------------------------|------|-------|--------|-------|
| | | White | Blue | Black | Orange | Green |
| Carmustine (BCNU)* | 3.3 mg/ml | 11.2 | 10.7 | 11.0 | 67.3 | 67.1 |
| Cisplatin | 1.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Cyclophosphamide | 20.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Dacarbazine | 10.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Doxorubicin HCL | 2.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Etoposide | 20.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Fluorouracil | 50.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Methotrexate | 25.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Paclitaxel | 6.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| ThioTepa* | 10.0 mg/mL | 25.2 | 21.5 | 11.1 | 47.8 | 169.1 |
| Mitomycin C | 0.5 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Vincristine Sulfate | 1.0 mg/mL | >240 | >240 | >240 | >240 | >240 |
| Fentanyl Citrate | 100.0 mcg/2mL | >240 | >240 | >240 | >240 | >240 |
| *Please note that the following drugs have extremely low permeation time: | | | | | | |
| 1. Carmustine (3.3 mg/mL) | | | | | | |
2. Thiotepa (10 mg/mL)
Warning: Do not use with Carmustine and ThioTepa.
# 6. Comparative Technological Characteristics & Performance Information Summary
Table 6.1 Summary of Technological Characteristics Comparison between Proposed Device and Predicate Device
| | | Device Performance / Characteristic | | Comparison Analysis | |
|---------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------|
| Character-<br>istics | Requirement /<br>Standard | Predicate Device<br>(K200181) | Subject Device | Comparison | Any<br>Safety &<br>Effective-<br>ness Issue |
| Material | - | Nitrile | Nitrile | Similar | No |
| Color | - | Black | White<br>Blue<br>Black<br>Orange<br>Green | Minor<br>Different<br>(Supported by<br>Biocompatibility Study) | No |
| Product<br>Code | | LZA<br>LZC | LZA<br>LZC | Similar | No |
| Type of<br>Use | - | Single Use | Single Use | Similar | No |
| Material | - | Nitrile | Nitrile | Similar | No |
| Powder-<br>Free | - | Yes | Yes | Similar | No |
| Sterility | - | Non-sterile | Non-Sterile | Similar | No |
| Intended<br>Use /<br>Indications<br>for Use | - | The Black Colored,<br>Powder Free Nitrile<br>Examination Gloves,<br>Non-Sterile, and Tested<br>for Use with<br>Chemotherapy Drugs and<br>Fentanyl Citrate is a<br>specialty medical glove<br>which is a disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>examiner and patient. In<br>addition, these gloves are<br>worn to protect the<br>wearer against exposure<br>to chemotherapy drugs<br>and Fentanyl Citrate. | Powder-Free Nitrile<br>Examination Glove (White,<br>Blue, Black, Orange and<br>Green Color) Tested for<br>Use with Chemotherapy<br>Drugs and Fentanyl is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's<br>hand, in order to prevent<br>contamination between<br>patient and examiner, and<br>also prevent transmission of<br>a wide variety of diseases to<br>both patient and health care<br>personnel. In addition,<br>these gloves were tested for<br>chemotherapy drug<br>permeation test. | Similar | No |
| Dimension | ASTM D6319-10 | Meets requirement | Meets requirement | Similar | No |
| Physical<br>Properties | ASTM D6319-10 | Meets requirement | Meets requirement | Similar | No |
| Freedom<br>from Holes | ASTM D6319-10<br>(Tested according<br>to ASTM D5151-<br>06) | Meets requirements of<br>ASTM D6319-10<br>(ASTM D5151) | Meets ASTM D6319-10,<br>21 CFR 800.20 (Tested in<br>accordance with ASTM<br>D5151-06) | Similar | No |
| Powder<br>Residual | ASTM D6124-06 | Meets requirement | Meets requirement | Similar | No |
| Biocompati<br>bility | .In Vitro<br>Cytotoxicity-<br>ISO 10993-5 | Under the conditions of<br>the study, the device is<br>non-cytotoxic | Under the condition of<br>study, the device extract<br>shows potential toxicity. | Different<br>(Supported by<br>Acute<br>Systemic<br>Toxicity<br>Study) | No |
| | Acute Systemic<br>Toxicity - ISO<br>10993-11 | - | Not an acute systemic toxic<br>under the condition of the<br>study. | Different<br>(Device is<br>proven safe to<br>used) | No |
| | Skin Sensitization<br>- ISO 10993-10 | Under the condition of<br>the study, the device is<br>non-sensitization | Not a sensitizer under the<br>conditions of the study. | Similar | No |
| | Skin Irritation -<br>ISO 10993-10 | Under the conditions of<br>the study, the device is<br>non irritating | Not a primary skin irritant<br>under the conditions of the<br>study. | Similar | No |
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| Characteristic | Predicate Device<br>(K200181) | Proposed Device | Comparison Analysis | Justification |
|--------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Color | Black | White<br>Blue<br>Black<br>Orange<br>Green | Minor Different<br>(Supported by<br>Biocompatibility<br>Study) | Device in different color has<br>the same non-sensitization,<br>non-irritating and non-toxic<br>characteristics. |
| Biocompatibility<br>(In Vitro<br>Cytotoxicity) | Meets ISO 10993:5<br>Under the<br>conditions of the<br>study, the device is<br>non-cytotoxic | ISO 10993:5<br>Under the condition of<br>the study, the<br>device extract shows potential<br>cytotoxicity. | Different<br>(Supported by<br>Acute Systemic<br>Toxicity Study) | Device has potential cytotoxic<br>effect. Therefore, Acute<br>Systemic Toxicity test is<br>conducted to prove that<br>device does not have potential<br>toxicity. |
| Biocompatibility<br>(Acute Systemic<br>Toxicity) | - | Meets ISO 10993-11<br>Not an acute systemic<br>toxic under the<br>condition of the study. | Different<br>(Device is proven<br>safe to use) | Device is does not have<br>potential toxicity effect.<br>Therefore, similar with the<br>predicate. |
Table 6.2 Summary of Difference in Technological Characteristics
## Table 6.3: Test Results for Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (ASTM D6978-05)
| Chemotherapy<br>Drug | Concentration | Minimum Breakthrough Detection Time (minutes) | | | | | |
|----------------------|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|------|-------|--------|-------|
| | | Predicate Device<br>(K200181) | Proposed Device | | | | |
| | | | White | Blue | Black | Orange | Green |
| Carmustine (BCNU)* | 3.3 mg/ml | 54.1 | 11.2 | 10.7 | 11.0 | 67.3 | 67.1 |
| Cisplatin | 1.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Cyclophosphamide | 20.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Dacarbazine | 10.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Doxorubicin HCL | 2.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Etoposide | 20.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Fluorouracil | 50.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| Methotrexate | 25.0 mg/mL | - | >240 | >240 | >240 | >240 | >240 |
| Paclitaxel | 6.0 mg/mL | >240 | >240 | >240 | >240 | >240 | >240 |
| ThioTepa* | 10.0 mg/mL | 1.3 | 25.2 | 21.5 | 11.1 | 47.8 | 169.1 |
| Mitomycin C | 0.5 mg/mL | - | >240 | >240 | >240 | >240 | >240 |
| Vincristine Sulfate | 1.0 mg/mL | - | >240 | >240 | >240 | >240 | >240 |
| Fentanyl Citrate | 100.0 mcg/2mL | >240 | >240 | >240 | >240 | >240 | >240 |
| *Warning Statement: | | The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time:<br>1. Carmustine (3.3 mg/mL)<br>2. Thiotepa (10 mg/mL) | | | | | |
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# 7. Summary of Non-Clinical Test:
Below are the non-clinical tests that was conducted and the purposes:
| Test | Purpose |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Dimension Test | To evaluate whether the device meets the current ASTM D6319-19 |
| Freedom From Hole | To evaluate whether the subject meets current 21 CFR 800.20, ASTM<br>D6319-19 and test according to ASTM D5151-19 |
| Physical Property Test | To evaluate whether the subjects meet current ASTM D6319-19 and test<br>according to ASTM D412 and ASTM D573 |
| Residual Powder Test | To evaluate whether the subjects meet current ASTM D6319-19 and test<br>according to ASTM D6124-06 |
| Biocompatibility Test<br>(Skin Irritation) | To determine whether skin irritation potential of device meets ISO 10993-<br>10. |
| Biocompatibility Test<br>(Skin Sensitization) | To determine whether skin sensitization potential of device meets ISO<br>10993-10. |
| Biocompatibility Test<br>(Acute Systemic<br>Toxicity) | To determine whether leachable extracted from the device would cause<br>acute systemic toxicity and meet ISO 10993-11. |
Table 7.1 Summary of Dimension Test
| | Standard | | Minimum | Device Performance (Minimum) | | | | |
|-----------------------|----------------------|------|-----------------|------------------------------|---------|---------|---------|---------|
| Characteristics | | Size | Requirement | White | Blue | Black | Orange | Green |
| Length | ASTM<br>D6319-<br>19 | XS | 220 mm | 239 mm | 235 mm | 242 mm | 243 mm | 244 mm |
| | | S | 220 mm | 236 mm | 237 mm | 242 mm | 244 mm | 241 mm |
| | | M | 230 mm | 230 mm | 230 mm | 240 mm | 245 mm | 245 mm |
| | | L | 230 mm | 234 mm | 237 mm | 255 mm | 243 mm | 242 mm |
| | | XL | 230 mm | 232 mm | 246 mm | 240 mm | 240 mm | 245 mm |
| | | XXL | 230 mm | 238 mm | 238 mm | 242 mm | 240 mm | 245 mm |
| Width | ASTM<br>D6319-<br>19 | XS | $70 \pm 10$ mm | 75 mm | 77 mm | 77 mm | 77 mm | 77 mm |
| | | S | $80 \pm 10$ mm | 85 mm | 87 mm | 86 mm | 87 mm | 85 mm |
| | | M | $95 \pm 10$ mm | 93 mm | 86 mm | 92 mm | 97 mm | 97 mm |
| | | L | $110 \pm 10$ mm | 104 mm | 107 mm | 104 mm | 108 mm | 107 mm |
| | | XL | $120 \pm 10$ mm | 112 mm | 111 mm | 114 mm | 118 mm | 117 mm |
| | | XXL | $130 \pm 10$ mm | 128 mm | 128 mm | 127 mm | 124 mm | 126 mm |
| Thickness<br>(Finger) | ASTM<br>D6319-<br>19 | XS | 0.05 mm | 0.08 mm | 0.08 mm | 0.09 mm | 0.27 mm | 0.25 mm |
| | | S | | 0.08 mm | 0.09 mm | 0.05 mm | 0.27 mm | 0.27 mm |
| | | M | | 0.10 mm | 0.11 mm | 0.10 mm | 0.28 mm | 0.27 mm |
| | | L | | 0.09 mm | 0.08 mm | 0.10 mm | 0.27 mm | 0.27 mm |
| | | XL | | 0.07 mm | 0.06 mm | 0.10 mm | 0.28 mm | 0.27 mm |
| | | XXL | | 0.07 mm | 0.08 mm | 0.07 mm | 0.28 mm | 0.26 mm |
| Thickness<br>(Palm) | ASTM<br>D6319-<br>19 | XS | 0.05 mm | 0.05 mm | 0.05 mm | 0.06 mm | 0.19 mm | 0.19 mm |
| | | S | | 0.05 mm | 0.05 mm | 0.06 mm | 0.19 mm | 0.19 mm |
| | | M | | 0.06 mm | 0.06 mm | 0.05 mm | 0.19 mm | 0.18 mm |
| | | L | | 0.05 mm | 0.05 mm | 0.06 mm | 0.22 mm | 0.20 mm |
| | | XL | | 0.05 mm | 0.05 mm | 0.06 mm | 0.22 mm | 0.18 mm |
| | | XXL | | 0.05 mm | 0.05 mm | 0.06 mm | 0.20 mm | 0.19 mm |
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| Characteristics | Standard | Size | Minimum<br>Requirement | Device Performance (Minimum) | | | | |
|-----------------------|-------------------------------------------------------------------------------------|------|------------------------|------------------------------|--------|--------|--------|--------|
| | | | | White | Blue | Black | Orange | Green |
| Freedom from<br>Holes | A;STM<br>D6319-19<br>21 CFR<br>800.20<br>(Tested<br>as per<br>ASTM<br>D5151-<br>19) | XS | AQL 2.5 | Passed | Passed | Passed | Passed | Passed |
| | | S | | Passed | Passed | Passed | Passed | Passed |
| | | M | | Passed | Passed | Passed | Passed | Passed |
| | | L | | Passed | Passed | Passed | Passed | Passed |
| | | XL | | Passed | Passed | Passed | Passed | Passed |
| | | XXL | | Passed | Passed | Passed | Passed | Passed |
Table 7.2 Summary of Freedom of Hole Test
Table 7.3 Summary of Physical Property Test
| Characteristics | Standard | Size | Minimum<br>Requirement | Device Performance (Minimum) | | | | |
|-------------------------------------|---------------------------------------|------|------------------------|------------------------------|------|-------|--------|-------|
| | | | | White | Blue | Black | Orange | Green |
| Before Aging<br>(Tensile [MPa]) | | XS | 14 MPa | 23.2 | 21.0 | 21.3 | 20.7 | 21.1 |
| | | S | | 21.2 | 24.5 | 23.6 | 20.0 | 20.1 |
| | | M | | 22.8 | 21.6 | 22.3 | 21.0 | 28.8 |
| | | L | | 20.7 | 23.7 | 21.6 | 21.4 | 20.9 |
| | | XL | | 20.5 | 20.2 | 24.3 | 20.9 | 22.0 |
| | | XXL | | 22.8 | 23.6 | 22.2 | 23.0 | 22.1 |
| Before Aging<br>(Elongation<br>[%]) | ASTM<br>D6319-<br>19 | XS | 500 % | 528 | 520 | 515 | 527 | 533 |
| | | S | | 527 | 549 | 518 | 515 | 556 |
| | | M | | 520 | 522 | 530 | 549 | 548 |
| | | L | | 528 | 521 | 527 | 531 | 523 |
| | | XL | | 536 | 521 | 528 | 533 | 524 |
| | | XXL | | 526 | 524 | 528 | 525 | 525 |
| After Aging<br>(Tensile [MPa]) | (Tested<br>as per<br>ASTM<br>D412-16) | XS | 14 MPa | 23.0 | 20.2 | 23.0 | 24.5 | 21.4 |
| | | S | | 20.2 | 24.6 | 26.6 | 22.7 | 20.4 |
| | | M | | 26.8 | 19.8 | 22.7 | 22.2 | 26.4 |
| | | L | | 24.9 | 26.1 | 21.4 | 25.2 | 21.7 |
| | | XL | | 26.3 | 23.1 | 28.8 | 22.2 | 24.6 |
| | | XXL | | 23.3 | 21.0 | 20.0 | 27.4 | 20.1 |
| After Aging<br>(Elongation<br>[%]) | | XS | 400 % | 432 | 461 | 414 | 430 | 465 |
| | | S | | 427 | 466 | 421 | 412 | 446 |
| | | M | | 444 | 457 | 425 | 466 | 440 |
| | | L | | 488 | 423 | 436 | 447 | 455 |
| | | XL | | 458 | 424 | 434 | 432 | 431 |
| | | XXL | | 437 | 435 | 433 | 425 | 425 |
{10}------------------------------------------------
| Characteristics | Standard | Size | Minimum<br>Requirement | Device Performance (Minimum) | | | | |
|----------------------------|--------------------------------------------------------------------|------|------------------------------------------------|------------------------------|------|-------|--------|-------|
| | | | | White | Blue | Black | Orange | Green |
| Residual<br>Powder<br>(mg) | ASTM<br>D6319-<br>19<br>(Tested<br>as per<br>ASTM<br>D6124-<br>06) | XS | ≤ 2.0 mg of<br>residual<br>powder per<br>glove | 0.98 | 0.68 | 0.80 | 0.82 | 0.96 |
| | | S | | 0.86 | 0.72 | 0.86 | 0.98 | 0.82 |
| | | M | | 0.92 | 0.88 | 0.94 | 0.92 | 0.92 |
| | | L | | 0.78 | 0.76 | 0.92 | 0.78 | 0.90 |
| | | XL | | 0.84 | 0.98 | 0.84 | 0.68 | 0.86 |
| | | XXL | | 0.74 | 0.82 | 0.92 | 0.84 | 0.98 |
Table 7.4 Summary of Residual Powder Test
Table 7.5 Summary of Biocompatibility Test
| Characteristics | Standard | Minimum<br>Requirement | Device Performance | | | | |
|----------------------------|--------------|------------------------|------------------------------------------------------------------|------|-------|--------|-------|
| | | | White | Blue | Black | Orange | Green |
| Skin Irritation | ISO 10993-10 | N/A | Non-irritant under the conditions of the study. | | | | |
| Skin<br>Sensitization | ISO 10993-10 | N/A | Non-sensitizer under the conditions of the study. | | | | |
| Acute Systemic<br>Toxicity | ISO 10993-11 | N/A | Not an acute systemic toxic under the condition of<br>the study. | | | | |
# 8. Summary of Clinical Test:
Clinical data is not required.
# 9. Conclusion:
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.
