Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs

K230217 · Grand Work Plastic Products Co., Ltd. · KGO · May 13, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230217
• Device Name: Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
• Applicant: Grand Work Plastic Products Co., Ltd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: May 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

This 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 D6978-05(Reapproved 2019).

Device Story

Sterile, powder-free, cream-colored, hand-specific surgical glove made from synthetic polyisoprene latex. Designed for single use by operating room personnel to protect surgical wounds from contamination. Tested for resistance to chemotherapy drug permeation per ASTM D6978-05. Provides a physical barrier; does not involve active sensing, software, or electronic processing. Used in clinical surgical settings. Benefits include protection of the surgical site from contamination and protection of the wearer from exposure to specific chemotherapy agents.

Clinical Evidence

No clinical data required. Substantial equivalence supported by non-clinical bench testing, including physical properties (tensile strength, elongation), barrier integrity (freedom from holes), residual powder, protein content, and chemotherapy drug permeation resistance per ASTM D6978-05. Biocompatibility testing performed per ISO 10993-5, 10, 11, and 23.

Technological Characteristics

Material: Synthetic polyisoprene latex. Form factor: Hand-specific, beaded cuff, sterile, powder-free. Sterilization: Radiation (10^-6 SAL). Standards: ASTM D3577-19 (physical properties/dimensions), ASTM D5151-19 (holes), ASTM D6124-06 (powder), ASTM D6978-05 (chemotherapy permeation), ISO 10993 (biocompatibility). No electronic or software components.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. Tested for resistance to chemotherapy drug permeation per ASTM D6978-05. Contraindicated for use with Carmustine and Thiotepa due to low permeation times.

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

• Hartalega NGC SDN BHD Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) (K221718)

Submission Summary (Full Text)

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May 13, 2023

Grand Work Plastic Products Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710

Re: K230217

Trade/Device Name: Sterile Polyisoprene Powder Free Surgical Glove, 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 Dated: April 11, 2023 Received: April 12, 2023

Dear Kathy Liu:

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 mediation-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) K230217

#### Device Name

Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs

#### Indications for Use (Describe)

This 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 D6978-05(Reapproved 2019).

| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes |
|------------------------------|------------------------------------------------------|
| Carmustine (3.3mg/ml) | 25.4 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Doxorubicin HCL (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Methotrexate (25mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 23.3 |
| Vincristine Sulfate (1mg/ml) | >240 |

Please note that the following drugs have low permeation times: Carmustine (BCNU): 25.4 minutes, Thiotepa: 23.3 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)

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

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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: K230217 Date Prepared: March 25, 2023

#### 1. Owner's Identification:

Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: [phone]

Contact: Ms. Kathy Liu, Project Manager Grand Work Plastic Products Co., Ltd Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: [phone]

#### 2. Name of the Device:

Trade Name: Sterile Polyisoprene Powder Free Surgical Glove, 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 Device Class: Class I

## 3. Predicate Device Information:

Hartalega NGC SDN BHD Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) (K221718)

#### 4. Device Description:

Sterile Polyisoprene Powder Free Surgical Glove, tested for Use with Chemotherapy Drugs is a disposable singleuse, sterile, Cream-colored and powder-free surgical glove made from synthetic polyisoprene latex.

#### 5. Indications for Use:

This 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 D6978-05 (Reapproved 2019).

| Chemotherapy Drug | Minimum BDT (Minutes) |
|----------------------------|-----------------------|
| Carmustine (3.3mg/ml) | 25.4 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Doxorubicin HCL (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Methotrexate (25mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 23.3 |

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Vincristine Sulfate (1 mg/ml)

>240

Please note that the following drugs have low permeation times: Carmustine (BCNU): 25.4 minutes, Thiotepa: 23.3 minutes Warning: Do not use with Carmustine and Thiotepa

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

| Items | Subject Device<br>K230217 | Predicate Device<br>K221718 | Remark |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Trade Name | Sterile Polyisoprene Powder<br>Free Surgical Glove, Tested for<br>Use with Chemotherapy Drugs | Polyisoprene Powder Free Surgical Glove<br>Tested for Use with Chemotherapy Drugs<br>(Natural) | Similar |
| Product Code | KGO, LZC | 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 | This glove is intended to be<br>worn by operating room<br>personnel to protect a surgical<br>wound from contamination. In<br>addition, these gloves were<br>tested for use with<br>chemotherapy drugs in<br>accordance with ASTM<br>D6978-05 (Reapproved 2019). | Polyisoprene Powder Free Surgical Glove<br>Tested for Use with Chemotherapy Drugs<br>is intended to be worn by operating room<br>personnel to protect surgical wound from<br>contamination. It is also tested for use<br>against Chemotherapy Drugs.<br>The gloves were tested for use with<br>chemotherapy drugs as per ASTM D6978-<br>05 (Reapproved 2019) Standard Practice<br>for Assessment of Resistance of Medical<br>Gloves to Permeation by Chemotherapy<br>Drugs. | Similar |
| Type of use | Over the counter use | Over the counter use | Same |
| Materials | Polyisoprene | Polyisoprene | Same |
| Color | Cream | Natural | Different |
| Design | · Single Use<br>· Sterile<br>• Powder-Free<br>· Hand Specific<br>• Beaded cuff | · Single Use<br>· Sterile<br>• Powder-Free<br>· Hand Specific<br>• Beaded cuff | Same |
| Sterility | Sterile | Sterile | Same |
| Sterilization | Radiation 10-6 SAL | Radiation 10-6 SAL | Same |
| Freedom from<br>holes | Meets ASTM D3577-19<br>requirements of AQL 1.5 | Meets ASTM D3577-19 requirements of<br>AQL 1.5 | Similar |
| Length | Length (mm): ≥ 265 mm | Length (mm): ≥ 265 mm | Similar |
| 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) | Similar |
| Thickness | Cuff Thickness: ≥ 0.10 mm<br>Palm Thickness: ≥ 0.10 mm | Cuff Thickness: ≥ 0.10 mm<br>Palm Thickness: ≥ 0.10 mm | Similar |
| | Finger Thickness: ≥ 0.10 mm | Finger Thickness: ≥ 0.10 mm | |
| Physical<br>Properties | Tensile Strength Before Aging:<br>≥ 17 MPa<br>Tensile Strength After Aging: ≥<br>12 MPa<br>Ultimate Elongation Before<br>Aging: ≥ 650 %<br>Ultimate Elongation After<br>Aging: ≥ 490 % | Tensile Strength Before Aging: ≥ 17 MPa<br>Tensile Strength After Aging: ≥ 12 MPa<br>Ultimate Elongation Before Aging: ≥<br>650 %<br>Ultimate Elongation After Aging: ≥ 490 % | Similar |
| Powder residual | Residual Powder: ≤ 2 mg per<br>glove | Residual Powder: ≤ 2 mg per glove | Similar |
| In Vitro Cytotoxicity | Under the conditions of this<br>study, the test article extract<br>showed potential toxicity to<br>L929 cells. | Under the conditions of the study, the<br>device was found to be cytotoxic | Similar |
| Primary Skin<br>Irritation | The test result showed that the<br>polar and non-polar extract of<br>the final test sample score is less<br>1.0, the requirements of the test<br>are met. | Under the conditions of the study, the<br>device is not an irritant | Similar |
| Dermal Sensitization | Under the conditions of this<br>study, the test article extract<br>showed no significant evidence<br>of causing skin sensitization | Under the conditions of the study, the<br>device is not a sensitizer | Similar |
| Acute Systemic<br>Toxicity | Under the conditions of this<br>study, there was no evidence<br>of Acute systemic toxicity<br>from the extract.<br>The test article extract met the<br>requirements of this study. | Under the conditions of the study, there<br>was no evidence of systemic toxicity | Similar |
| Pyrogenicity Test | Under the conditions of this<br>study, no rabbit shows an<br>individual rise in temperature of<br>0.5℃ or more, the test article<br>Sterile Polyisoprene Powder<br>Free Surgical Gloves, Tested for<br>Use with Chemotherapy Drugs<br>meets the requirements of<br>pyrogen test. | Under the conditions of the study, the test<br>article was non-pyrogenic | Similar |
| Endotoxin Test | ≤0.5 units/pair of gloves | Not Performed | Different |
| Chemotherapy Drug<br>Permeation Claim | See below comparison table | See below comparison table | Similar |

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# Chemotherapy Permeation Comparison Claim:

| Tested Chemotherapy Drug and | Minimum BDT (Minutes) | | Remark |
|------------------------------|---------------------------|-----------------------------|---------|
| Concentration | Subject Device<br>K230217 | Predicate Device<br>K221718 | |
| Carmustine (3.3mg/ml) | 25.4 | 12.3 | Similar |
| Cisplatin (1mg/ml) | >240 | >240 | Same |
| Cyclophosphamide (20mg/ml) | >240 | >240 | Same |

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| Dacarbazine (10.0 mg/ml) | Not performed | >240 | Different* |
|-------------------------------|---------------|------|------------|
| Doxorubicin HCL (2 mg/ml) | >240 | >240 | Same |
| Etoposide (20mg/ml) | >240 | >240 | Same |
| Fluorouracil (50mg/ml) | >240 | >240 | Same |
| Methotrexate (25mg/ml) | >240 | >240 | Same |
| Mitomycin C (0.5 mg/ml) | >240 | >240 | Same |
| Paclitaxel (6mg/ml) | >240 | >240 | Same |
| Thiotepa (10mg/ml) | 23.3 | 17.4 | Similar |
| Vincristine Sulfate (1 mg/ml) | >240 | >240 | Same |

* Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this difference does not raise questions of safetv and effectiveness.

#### 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 (Reapproved 2022) Standard Test Method for Residual Powder on Medical Gloves
- · ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to
- Permeation by Chemotherapy Drugs
- 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
- · U.S. Pharmacopeia endotoxin test

#### 8. Specification for subject Gloves:

| Technological<br>Characteristics | Standard/Test/FDA Guidance | Result Summary | Conclusion |
|----------------------------------|----------------------------|---------------------------------------------------------------------|------------|
| Dimensions | ASTM D3577-19 | Meets ASTM D3577<br>requirements for length, width<br>and thickness | Same |
| --Length | Minimum 265mm | 280-305mm | Pass |
| --Palm Width (size) | (mm) | Average value in mm | |
| 5.5 | 70±6 | 73 | Pass |
| 6.0 | 76±6 | 79 | Pass |
| 6.5 | 83±6 | 84 | Pass |
| 7.0 | 89±6 | 90 | Pass |
| 7.5 | 95±6 | 96 | Pass |
| 8.0 | 102±6 | 101 | Pass |
| 8.5 | 108±6 | 108 | Pass |
| 9.0 | 114±6 | 114 | Pass |
| --Thickness | | Average value in mm | |
| Finger | Minimum 0.10 | 0.22-0.24 | Pass |
| Palm | Minimum 0.10 | 0.22 | Pass |
| Cuff | Minimum 0.10 | 0.17-0.18 | Pass |
| Physical Properties | ASTM D3577-19 | Meets ASTM D3577-19 | |
| Tensile Strength, Before | 17MPa, min | Average 20-21MPa | Pass |

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| Aging | | | |
|-------------------------------------------------|----------------------------------------------------------------|------------------------|------|
| Ultimate Elongation,<br>Before Aging | 650%, min | Average 780-823% | Pass |
| Stress at 500% Elongation | 7.0 MPa, max | Average 2.5-3.1MPa | Pass |
| Tensile Strength, After<br>Accelerated Aging | 12 MPa, min | Average 18-20MPa | Pass |
| Ultimate Elongation, After<br>Accelerated Aging | 490%, min | Average 747-809 % | Pass |
| 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>$\leq$ 2 mg per glove | 0.10-0.27 mg per glove | Pass |
| Aqueous Extractable<br>Protein Content | ASTM D3577-19<br>ASTM D5712-15<br>$\leq$ 200ug/dm2 | $\leq$ =50ug/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 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. |
| Pyrogen Test<br>10993-11 | Under the conditions of this study, no rabbit shows an individual rise in<br>temperature of 0.5°C or more, the test article Sterile Polyisoprene Powder Free<br>Surgical Gloves, Tested for Use with Chemotherapy Drugs meets the<br>requirements of pyrogen test. |

## 10. Clinical Performance Data:

Not applicable. There was no clinical data required to support the subject device as the indication for use is equivalent to the predicate device.

## 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.