Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs

K232444 · Grand Work Plastic Products Co., Ltd. · KGO · Dec 20, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K232444
• Device Name: Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
• Applicant: Grand Work Plastic Products Co., Ltd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Dec 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978.

Device Story

Sterile, powder-free, natural-colored, single-use surgical gloves made from rubber latex. Used by operating room personnel to protect surgical wounds from contamination. Tested for resistance to permeation by chemotherapy drugs per ASTM D6978. Provides barrier protection; however, specific chemotherapy drugs (Carmustine, Thiotepa) show low permeation times, necessitating a warning against use with these agents. Available in sizes 5.5 through 9.0. Sterilized via radiation.

Clinical Evidence

No clinical data. Bench testing only, including ASTM D3577 (physical properties), ASTM D5151 (freedom from holes), ASTM D6978 (chemotherapy permeation), and ISO 10993 series (biocompatibility: cytotoxicity, skin irritation, sensitization, systemic toxicity, pyrogenicity).

Technological Characteristics

Material: Natural rubber latex. Dimensions/Thickness: Meets ASTM D3577-19 (Finger/Palm/Cuff ≥ 0.10 mm). Sterilization: Radiation (SAL 10^-6). Connectivity: None. Software: None.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. Tested for use with chemotherapy drugs per ASTM D6978. Warning: Do not use with Carmustine or Thiotepa.

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

• Careplus (M) SDN BHD ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs (K202765)

Reference Devices

• Medline Industries, Inc. Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs (K202668)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

December 20, 2023

Grand Work Plastic Products Co., Ltd. Wu Yuli General Manager Donggao Industrial Zone Zanhuang County, Hebei 050000 China

Re: K232444

Trade/Device Name: Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC, OPJ Dated: November 20, 2023 Received: November 20, 2023

Dear Wu Yuli:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices

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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) K232444

#### Device Name

Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs

#### Indications for Use (Describe)

The glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978.

| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes |
|-----------------------------------------|------------------------------------------------------|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 14.0 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thio Tepa, 10mg/ml (10,000ppm) | 16.1 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |

Please note that the following drugs have low permeation times: Carmustine (BCNU): 14.0 minutes, Thiotepa: 16.1 minutes 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)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR §807.92.

The assigned 510(K) number is: K232444 Date Prepared: December 16, 2023

#### 1. Owner's Identification:

Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: [phone] Email: fdareg(@hongray.com.cn Contact: Mrs. Wu Yuli Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: [phone] Email: [e-mail]

#### 2. Name of the Device:

Trade Name: Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs Common Name: Surgeon's Glove Classification Name: Surgeon's Glove Classification Regulation: 21 CFR 878.4460 Product Code: KGO, LZC, OPJ Device Class: Class 1

## 3. Predicate Device Information:

Primary Predicate Device: Careplus (M) SDN BHD ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs (K202765).

Reference device:

Medline Industries, Inc.

Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50ug/dm2 per Glove of Extractable Protein (K202668) This reference device is being used to support inclusion of additional chemotherapy drugs that were not tested in the predicate.

## 4. Device Description:

Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from rubber latex. They are in different sizes - 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Gloves meet the specification of ASTM D3577-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).

#### 5. Indications for Use:

The glove is intended to be worn by operating room personnel to protect surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978.

| Chemotherapy Drug | Minimum Breakthrough Detection Time (Minutes) |
|---------------------------------------|-----------------------------------------------|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |

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| Carboplatin 10mg/ml (10,000 ppm) | >240 |
|-----------------------------------------|------|
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 14.0 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thio Tepa, 10mg/ml (10,000ppm) | 16.1 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |

Please note that the following drugs have low permeation times: Carmustine (BCNU): 14.0 minutes, Thiotepa: 16.1 minutes Warning: Do not use with Carmustine and Thiotepa

# 6. Comparison table of Subject Device and Predicate Device:

| Items | Subject Device<br>K232444 | Predicate Device<br>K202765 | Remark | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--|
| Trade Name | Sterile Powder Free Latex Surgical<br>Gloves, Tested for Use with<br>Chemotherapy Drugs | ENCORE Latex Textured Surgical<br>Gloves, Powder Free with Protein<br>Content Labeling Claim (50<br>micrograms or less) and Tested for<br>use with Chemotherapy drugs | Similar* | |
| Product Code | KGO, LZC, OPJ | KGO, LZC | Same | |
| Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same | |
| Classification | I | I | Same | |
| Regulation Name | Surgeon's Glove | Surgeon's Glove | Same | |
| Indications for Use | Sterile Powder Free Latex Surgical<br>Gloves, Tested for Use with<br>Chemotherapy Drugs is intended to be<br>worn by operating room personnel to<br>protect a surgical wound from<br>contamination. In addition, these<br>gloves were tested for use with<br>chemotherapy drugs in accordance<br>with ASTM D6978. | Powder Free Surgical Gloves are<br>sterile disposable devices intended to<br>be worn by operating room personnel<br>to protect surgical wound from<br>contamination.<br>These gloves were tested for use with<br>chemotherapy drugs as per ASTM<br>D6978 Standard Practice for<br>Assessment of Resistance of Medical<br>Gloves to Permeation by<br>Chemotherapy. | Same | |
| Type of use | Over the counter use | Over the counter use | Same | |
| Materials | Latex | Latex | Same | |
| Color | Natural | Natural | Same | |
| Single<br>Use/Disposable | Single Use | Single Use | Same | |
| Sterility | Sterile | Sterile | Same | |
| Sterilization<br>method | Radiation sterilization | Radiation sterilization | Same | |
| Sterility Assurance<br>Level (SAL) | 10-6 | 10-6 | Same | |
| Shelf-life/expiration<br>date | 3 years | Not available | Different** | |
| Freedom from<br>holes | Meets ASTM D3577-19 requirements<br>of AQL 1.5 | Meets ASTM D3577-19 requirements<br>of AQL 1.5 | Same | |
| Length | 5.5: ≥ 245 mm<br>6-9: ≥ 265 mm | 5.5: ≥ 245 mm<br>6-9: ≥ 265 mm | Same | |
| Dimensions | 5.5:70 ± 6 (mm)<br>6.0: 76 ± 6 (mm)<br>6.5: 83 ± 6 (mm)<br>7.0: 89 ± 6 (mm)<br>7.5: 95 ± 6 (mm)<br>8.0: 102 ± 6 (mm)<br>8.5: 108 ± 6 (mm)<br>9.0: 114 ± 6 (mm) | 5.5:70 ± 6 (mm)<br>6.0: 76 ± 6 (mm)<br>6.5: 83 ± 6 (mm)<br>7.0: 89 ± 6 (mm)<br>7.5: 95 ± 6 (mm)<br>8.0: 102 ± 6 (mm)<br>8.5: 108 ± 6 (mm)<br>9.0: 114 ± 6 (mm) | Same | |
| Thickness | Cuff Thickness: ≥ 0.10 mm<br>Palm Thickness: ≥ 0.10 mm<br>Finger Thickness: ≥ 0.10 mm | Cuff Thickness: ≥ 0.10 mm<br>Palm Thickness: ≥ 0.10 mm<br>Finger Thickness: ≥ 0.10 mm | Same | |
| Physical<br>Properties | Tensile Strength Before Aging: ≥ 24<br>MPa<br>Tensile Strength After Aging: ≥ 18<br>MPa<br>Ultimate Elongation Before Aging: ≥<br>750 %<br>Ultimate Elongation After Aging: ≥<br>560 % | Tensile Strength Before Aging: ≥ 24<br>MPa<br>Tensile Strength After Aging: ≥ 18<br>MPa<br>Ultimate Elongation Before Aging: ≥<br>750 %<br>Ultimate Elongation After Aging: ≥<br>560 % | Same | |
| Powder residual | Residual Powder: ≤ 2 mg per glove | Residual Powder: ≤ 2 mg per glove | Same | |
| In Vitro<br>Cytotoxicity | Under the conditions of this study, the<br>test article extract showed potential<br>toxicity to L929 cells. | Under the conditions of this study,<br>the test material is cytotoxic (grade 4)<br>at undiluted, 1:2, 1:4, 1:8 dilutions;<br>and Non-cytotoxic, grade 2 at 1:16<br>dilution, grade 0 at 1:32 and 1:64<br>dilutions | Same | |
| Acute Systemic<br>Toxicity | Under the conditions of this study,<br>there was no evidence of acute<br>systemic toxicity from the extract.<br>The test article extract met the<br>requirements of this study. | Under the conditions of this study,<br>the test material both inner and outer<br>surface did not reveal systemic<br>toxicity | Same | |
| Primary Skin<br>Irritation | The test result showed that the polar<br>and non-polar extract of the final test<br>sample score is less 1.0, the<br>requirements of the test are met. | Under the conditions of this study,<br>the test material did not cause and<br>irritant response. | Same | |
| Dermal<br>Sensitization | Under the conditions of this study, the<br>test article extract showed no<br>significant evidence of causing skin | Under the conditions of this study,<br>the test material did not produce a<br>skin sensitization effect. | Same | |
| | sensitization | | | |
| Material-Mediated<br>Pyrogenicity Test | The test article meets the requirements<br>of pyrogen test. | Non-Pyrogenic | Same | |
| Endotoxin | <20 EU/glove | Not available | Different*** | |
| Chemotherapy<br>Drug<br>Permeation Claim | See below comparison table | See below comparison table | / | |
| Protein Label Claim | No protein claim | Contains 50 micrograms or less of<br>total water extractable protein per<br>gram. | Different**** | |

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*The trade name will be indicated on labeling and it does not raise concerns of safety and does not affect the substantial equivalence in effectiveness and safety.

**The shelf life will be indicated on labeling, so this different does not raise safety and effectiveness concerns. ***The endotoxin is the required test item on surgical gloves and it will be supported with test report, so the difference does not raise concerns of safety and effectiveness.

****The protein claim will not be indicated on labeling of subject device, so the difference does not raise concerns of safety and effectiveness and does not affect the substantial equivalence in effectiveness and safety.

Chemotherapy Permeation Comparison Claim:

| Tested Chemotherapy Drug and<br>Concentration | Minimum Breakthrough Detection Time (Minutes) | | | Remark<br>(Compare with<br>K202668) |
|-----------------------------------------------|-----------------------------------------------|-----------------------------|-----------------------------|-------------------------------------|
| | Subject Device<br>K232444 | Predicate Device<br>K202765 | Reference Device<br>K202668 | |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | / | >240 | Same |
| Busulfan 6mg/ml (6,000 ppm) | >240 | / | >240 | Same |
| Carboplatin 10mg/ml (10,000 ppm) | >240 | / | >240 | Same |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 14.0 | 13.2 | 12.6 | Similar |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | / | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 | / | >240 | Same |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | / | >240 | Same |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | / | >240 | Same |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 | / | >240 | Same |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | >240 | Same |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | / | >240 | Same |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 | / | >240 | Same |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | / | >240 | Same |
| Melphalan, 5mg/ml (5,000ppm) | >240 | / | >240 | Same |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | >240 | Same |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 | / | >240 | Same |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | / | >240 | Same |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | >240 | Same |
| Paraplatin, 10mg/ml (10,000ppm) | >240 | / | >240 | Same |
| Rituximab, 10mg/ml (10,000ppm) | >240 | / | >240 | Same |
| Thio Tepa, 10mg/ml (10,000ppm) | 16.1 | 12.0 | 22.4 | Similar |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | >240 | >240 | Same |

Note: The permeation times of Carmustine and Thio Tepa will be listed on labeling and will add the warning "Do not use with Carmustine and Thiotepa", so this similar does not raise concerns of safety and effectiveness.

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#### 7 Summary of Non-Clinical Testing

Non-clinical testing was performed to verify that the subject device meets the acceptance criteria of the performance test and all design specifications. The test results demonstrated that the subject device complies with the following standards as shown below.

- ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
- · ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (2022) Standard Test Method for Residual Powder on Medical Gloves
- · ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to

Permeation by Chemotherapy Drugs

• ASTM D5712-15 (2020) Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method

- ISO 10993-5 In Vitro Cytotoxicity
- ISO 10993-23 Primary Skin Irritation
- ISO 10993-10 Dermal Sensitization
- · ISO 10993-11 Acute Systemic Toxicity
- ISO 10993-11 Pyrogen Test
- · U.S. Pharmacopeia Sterility Test

#### 8. Specification for subject Gloves:

| Technological<br>Characteristics | Standard/Test/FDA<br>Guidance | Result Summary | Conclusion |
|----------------------------------------------------|--------------------------------|---------------------------------------------------------------------|------------|
| Dimensions | ASTM D3577-19 | Meets ASTM D3577<br>requirements for length, width<br>and thickness | / |
| --Length | 5.5: ≥ 245 mm<br>6-9: ≥ 265 mm | 283-308mm | Pass |
| --Palm Width (size) | (mm) | Average value in mm | / |
| 5.5 | 70±6 | 72 | Pass |
| 6.0 | 76±6 | 76 | Pass |
| 6.5 | 83±6 | 83 | Pass |
| 7.0 | 89±6 | 88 | Pass |
| 7.5 | 95±6 | 95 | Pass |
| 8.0 | 102±6 | 101 | Pass |
| 8.5 | 108±6 | 105 | Pass |
| 9.0 | 114±6 | 110 | Pass |
| --Thickness | | Average value in mm | |
| Finger | Minimum 0.10 | 0.20-0.26 | Pass |
| Palm | Minimum 0.10 | 0.19-0.24 | Pass |
| Cuff | Minimum 0.10 | 0.16-0.19 | Pass |
| Physical Properties | ASTM D3577-19 | Meets ASTM D3577-19 | |
| Tensile Strength,<br>Before Aging | 24MPa, min | Average 24-29 MPa | Pass |
| Ultimate Elongation,<br>Before Aging | 750%, min | Average 750-851% | Pass |
| Stress at 500%<br>Elongation | 5.5 MPa, max | Average 2.1-4.5MPa | Pass |
| Tensile Strength, After<br>Accelerated Aging | 18MPa, min | Average 18-25MPa | Pass |
| Ultimate Elongation,<br>After Accelerated<br>Aging | 560%, min | Average 610-796 % | Pass |

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| Freedom from holes | ASTM D3577-19<br>ASTM D 5151-19<br>requirements of AQL1.5 | Meets AQL1.5 | Pass |
|----------------------------------------|-----------------------------------------------------------|-----------------------|------|
| Powder-Free | ASTM D3577-19<br>ASTM D 6124-06(2022)<br>≤ 2 mg per glove | 0.09-0.12mg per glove | Pass |
| Aqueous Extractable<br>Protein Content | ASTM D3577-19<br>ASTM D5712-15<br>≤200ug/dm² | 0.07-0.34ug/dm² | Pass |
| Sterility | 10-6 SAL | 10-6 SAL | Pass |

#### 9 Biocompatibility

| Test | Result Summary |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Skin Sensitization Test<br>ISO 10993-10 | Under the conditions of this study, the test article extract showed no significant<br>evidence of causing skin sensitization |
| Intracutaneous Reactivity<br>Test<br>ISO 10993-23 | The test result showed that the polar and non-polar extract of the final test<br>sample score is less 1.0, the requirements of the test are met. |
| Cytotoxicity Test<br>ISO 10993-5 | Under the conditions of this study, the test article extract showed potential<br>toxicity to L929 cells. |
| Acute Systemic Toxicity Test<br>10993-11 | Under the conditions of this study, there was no evidence of acute systemic<br>toxicity from the extract.<br>The test article extract met the requirements of this study. |
| Material-<br>mediated<br>Pyrogenicity<br>Test 10993-<br>11 | Under the conditions of this study, no rabbit shows an individual rise in<br>temperature of 0.5°C or more, the test article meets the requirements of pyrogen<br>test. |
| Endotoxin | <20 EU/glove |

#### 10_Clinical Performance Data:

Not applicable.

## 11. Conclusion:

The conclusions drawn from the non-clinical tests demonstrate that the Subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.