Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)

K221718 · Hartalega NGC Sdn. Bhd. · KGO · Sep 24, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221718
• Device Name: Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
• Applicant: Hartalega NGC Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Sep 24, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs. The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable, sterile, powder-free surgical glove; synthetic polyisoprene latex material. 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; does not include electronic or software components. Clinical benefit: reduction of surgical site contamination and protection of personnel from chemotherapy drug exposure.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including ASTM D3577-19 (physical properties), ASTM D5151-19 (freedom from holes), ASTM D6124-06 (residual powder), ASTM D6978-05 (chemotherapy permeation), and ISO 10993 series (biocompatibility).

Technological Characteristics

Material: Synthetic polyisoprene. Form: Sterile, powder-free, hand-specific, beaded cuff. Sterilization: Radiation (10-6 SAL). Compliance: ASTM D3577-19, ASTM D5151-19, ASTM D6124-06, ASTM D6978-05. Biocompatibility: ISO 10993-5, -10, -11. No software or electronic components.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination. Tested for resistance to chemotherapy drug permeation. Contraindicated for use with Carmustine and 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

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

Submission Summary (Full Text)

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September 24, 2022

Hartalega NGC SDN BHD Nurul Kong Deputy General Manager - Quality Assurance NO. 1 Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang, Selangor Darul Ehsan 43900 Malaysia

Re: K221718

Trade/Device Name: Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: August 15, 2022 Received: August 23, 2022

Dear Nurul Kong:

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 Oian.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 Ouality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K221718

Device Name

Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs

Indications for Use (Describe)

Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs.

The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---------------------------------------|------------------------------------------------|
| Carmustine (3.3 mg/ml) | 12.3 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 17.4 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |

Please note that Carmustine and Thiotepa have extremely low permeation times of 12.3 minutes and 17.4 minutes respectively.

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)

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#### 510(k) SUMMARY (K221718)

#### FOR

## POLYISOPRENE POWDER FREE SURGICAL GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS

(The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92)

## APPLICANT INFORMATION

| Date Prepared | : April 27, 2022 |
|-----------------------------------|------------------------------------------------------------------------------------------------------|
| Name | : Hartalega NGC Sdn. Bhd. |
| Address | : No. 1, Persiaran Tanjung,<br>Kawasan Perindustrian Tanjung,<br>43900 Sepang, Selangor,<br>Malaysia |
| Establishment Registration Number | : 3011200663 |

#### CORRESPONDENT AND/OR PREPARER INFORMATION

| Contact Name | : | Nurul Aisyah Kong |
|---------------|---|--------------------------------------------|
| Contact Title | : | Deputy General Manager – Quality Assurance |
| Phone Number | : | (603) 3280 3888 |
| Fax Number | : | (603) 3271 0135 |
| Contact Email | : | [e-mail] |

### DEVICE IDENTIFICATION

| Common Name of the Device | : | Surgeon's Glove |
|-------------------------------|---|-----------------------------------------------------------------------------------|
| Trade Name (Proprietary Name) | : | Polyisoprene Powder Free Surgical Glove Tested for Use with<br>Chemotherapy Drugs |
| Device Class | : | 1 |
| Product Code | : | KGO, LZC |
| Regulation Number | : | 21 CFR 878.4460 |
| Reason for 510(k) Submission | : | New device |

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### PREDICATE DEVICE INFORMATION

| 510(k) Number | Tradename | Product Code |
|---------------|-----------------------------------------------------------------------------------------------|--------------|
| K190018 | Gammex Non-Latex Polyisoprene White Surgical Gloves Tested for<br>Use with Chemotherapy Drugs | KGO |

### DESCRIPTION OF THE DEVICE:

Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from synthetic polyisoprene latex.

#### INDICATIONS FOR USE:

Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs.

The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---------------------------------------|------------------------------------------------|
| Carmustine (3.3 mg/ml) | 12.3 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 17.4 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |

Please note that Carmustine and Thiotepa have extremely low permeation times of 12.3 minutes and 17.4 minutes respectively.

Warning: Do not use with Carmustine and Thiotepa

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# TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE:

| Characteristics<br>and<br>Parameters | Subject Device | Predicate Device<br>(K190018) | Discussion | | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs | Gammex Non-Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs | Different | | |
| Applicant | Hartalega NGC Sdn. Bhd. | Ansell Healthcare Products LLC | Different | | |
| Product Code | KGO, LZC | KGO | Similar | | |
| Classification | 1 | 1 | Similar | | |
| Regulation<br>Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Similar | | |
| Regulation<br>Name | Surgeon's Glove | Surgeon's Glove | Similar | | |
| Indications for<br>Use | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs.<br>The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | Gammex Non Latex PI White Surgical Gloves Tested for Use with Chemotherapy Drugs are intended to be worn by operating room personnel to protect a surgical wound from contamination.<br>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. | Similar | | |
| | Chemotherapy<br>Drug and<br>Concentration | Minimum<br>Breakthrough<br>Detection Time in<br>Minutes | Chemotherapy<br>Drug and<br>Concentration | Minimum<br>Breakthrough<br>Detection Time in<br>Minutes | |
| | Carmustine<br>(3.3 mg/ml) | 12.3 | Carmustine<br>(3.3 mg/ml) | 10.2 | Performance<br>level for<br>Carmustine and<br>Thiotepa<br>between subject<br>device and<br>predicate device<br>is comparable.<br><br>Additional<br>Chemotherapy<br>drugs were<br>tested on the<br>predicate<br>device. |
| | Cisplatin<br>(1.0 mg/ml) | > 240 | Cisplatin<br>(1.0 mg/ml) | > 240 | |
| | Cyclophosphamide<br>(20.0 mg/ml) | > 240 | Cyclophosphamide<br>(20.0 mg/ml) | > 240 | |
| Test<br>Chemotherapy<br>Drugs | Dacarbazine<br>(10.0 mg/ml) | > 240 | Dacarbazine<br>(10.0 mg/ml) | > 240 | |
| | Doxorubicin<br>Hydrochloride<br>(2.0 mg/ml) | > 240 | Doxorubicin<br>Hydrochloride<br>(2.0 mg/ml) | > 240 | |
| | Etoposide<br>(20.0 mg/ml) | > 240 | Etoposide<br>(20.0 mg/ml) | > 240 | |
| | Fluorouracil<br>(50.0 mg/ml) | > 240 | Fluorouracil<br>(50.0 mg/ml) | > 240 | |
| | Methotrexate<br>(25.0 mg/ml) | > 240 | Methotrexate<br>(25.0 mg/ml) | > 240 | |
| | Mitomycin C<br>(0.5 mg/ml) | > 240 | Mitomycin C<br>(0.5 mg/ml) | > 240 | |
| | Paclitaxel<br>(6.0 mg/ml) | > 240 | Paclitaxel<br>(6.0 mg/ml) | > 240 | |
| | Thiotepa<br>(10.0 mg/ml) | 17.4 | Thiotepa<br>(10.0 mg/ml) | 11.5 | |

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| Characteristics<br>and<br>Parameters | Subject Device | Predicate Device (K190018) | Discussion | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| | Vincristine Sulfate<br>(1.0 mg/ml)<br>> 240<br>Please note that Carmustine and Thiotepa have extremely low permeation times of 12.3 minutes and 17.4 minutes respectively.<br><b>Warning:</b> Do not use with Carmustine and Thiotepa | Vincristine Sulfate (1.0 mg/ml) > 240<br>Blenoxane (15 mg/ml) > 240<br>Busulfan (6 mg/ml) > 240<br>Cytarabine (100 mg/ml) > 240<br>Daunorubicin (5 mg/ml) > 240<br>Docetaxel (10.0 mg/ml) > 240<br>Fludarabine (25 mg/ml) > 240<br>Gemcitabine (38 mg/ml) > 240<br>Idarubicin (1 mg/ml) > 240<br>Ifosfamide (50.0 mg/ml) > 240<br>Irinotecan (20.0 mg/ml) > 240<br>Mechlorethamine HCI (1.0 mg/ml) > 240<br>Melphalan (5 mg/ml) > 240<br>Mitoxantrone (2.0 mg/ml) > 240<br>Oxaliplatin (2.0 mg/ml) > 240<br>Paraplatin (10 mg/ml) > 240<br>Ellence (2 mg/ml) > 240<br>Rituximab (10 mg/ml) > 240<br>Please note that the following drugs have extremely low permeation times:<br>Carmustine (BCNU): 10.2 minutes and Thiotepa:11.5 minutes.<br><b>Warning:</b> Do not use with Carmustine and Thiotepa | | | |
| Type of use | Over the counter use | Over the counter use | Similar | | |
| Materials | Polyisoprene | Polyisoprene | Similar | | |
| Color | Natural | White | Different | | |
| Design | • Single Use<br>• Sterile<br>• Powder-Free<br>• Hand Specific | • Single Use<br>• Sterile<br>• Powder-Free<br>• Hand Specific | Similar | | |
| Characteristics<br>and<br>Parameters | Subject Device | Predicate Device<br>(K190018) | Discussion | | |
| | • Beaded Cuff | • Beaded Cuff | | | |
| Sterility | Sterile | Sterile | Similar | | |
| Sterilization | Radiation<br>10-6 SAL | Radiation<br>10-6 SAL | Similar | | |
| Freedom from<br>holes | Meets ASTM D3577-19 requirements of<br>AQL 1.5 | Meets ASTM D3577-19 requirements of<br>AQL 1.5 | Similar | | |
| Length | Length (mm): ≥ 265 mm | Length (mm): ≥ 265 mm | Similar.<br>Meets ASTM<br>D3577-19 | | |
| 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.<br>Meets ASTM<br>D3577-19 | | |
| 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 | Similar.<br>Meets ASTM<br>D3577-19 | | |
| Physical<br>Properties | Tensile Strength Before Aging: ≥ 17 MPa<br>Tensile Strength After Aging: ≥ 12 MPa<br>Ultimate Elongation Before Aging: ≥ 650 %<br>Ultimate Elongation After Aging: ≥ 490 % | Tensile Strength Before Aging: ≥ 17 MPa<br>Tensile Strength After Aging: ≥ 12 MPa<br>Ultimate Elongation Before Aging: ≥ 650 %<br>Ultimate Elongation After Aging: ≥ 490 % | Similar.<br>Meets ASTM<br>D3577-19 | | |
| Powder residual | Residual Powder: ≤ 2 mg per glove | Residual Powder: ≤ 2 mg per glove | Similar.<br>Meets ASTM<br>D3577-19 | | |
| In Vitro<br>Cytotoxicity<br>ISO 10993-5 | Under the conditions of the study, the device<br>was found to be cytotoxic | Under the conditions of the study, the device<br>was found to be cytotoxic | Similar | | |
| Primary Skin<br>Irritation<br>ISO 10993-10 | Under the conditions of the study, the device<br>is not an irritant | Under the conditions of the study, the device<br>not an irritant | Similar | | |
| Dermal<br>Sensitization<br>ISO 10993-10 | Under the conditions of the study, the device<br>is not a sensitizer | Under the conditions of the study, the device<br>not a sensitizer | Similar | | |
| Acute Systemic<br>Toxicity<br>ISO 10993-11 | Under the conditions of the study, there<br>was no evidence of systemic toxicity | Under the conditions of the study, there<br>was no evidence of systemic toxicity | Similar | | |
| Pyrogenicity<br>Test<br>USP <151> | Under the conditions of the study, the test<br>article was non-pyrogenic | N/A | Additional<br>Pyrogenicity<br>Test was tested<br>on the subject<br>device | | |
| Test Methodology/<br>Standards | Acceptance Criteria of the<br>Standards | | Result Summary | | |
| | Size | Length<br>(mm) | Width<br>(mm) | | |
| Dimensions<br><br>ASTM D3577-19<br>Standard Specification for<br>Rubber Surgical Gloves | 5.5 | Min 245 | 70 ± 6 | Meets ASTM D3577-19 requirements for length<br>and width. Similar to predicate device. | |
| | 6.0 | Min 265 | 76 ± 6 | | |
| | 6.5 | Min 265 | 83 ± 6 | | |
| | 7.0 | Min 265 | 89 ± 6 | | |
| | 7.5 | Min 265 | 95 ± 6 | | |
| | 8.0…