Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves

K220118 · Kl-Kepong Rubber Products Sdn. Bhd. · LZA · May 12, 2022 · General Hospital

Device Facts

• Record ID: K220118
• Device Name: Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves
• Applicant: Kl-Kepong Rubber Products Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: May 12, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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.

Device Story

Single-use, disposable nitrile rubber examination gloves; ambidextrous; beaded cuff; powder-free. Inner surface treated for smooth donning without lubricants. Supplied non-sterile in six sizes (XS-XXL). Used by healthcare professionals in clinical settings to provide a barrier against contamination. Chemotherapy-labeled version tested for permeation resistance against 11 specific chemotherapy drugs per ASTM D6978-05. Output is a physical barrier; healthcare providers use gloves during patient examinations or chemotherapy drug handling to reduce exposure risk and prevent cross-contamination.

Clinical Evidence

No clinical data. Bench testing only, including physical property testing (ASTM D6319), watertight testing (ASTM D5151), residual powder testing (ASTM D6124), chemotherapy drug permeation testing (ASTM D6978), and biocompatibility testing (ISO 10993-10/11).

Technological Characteristics

Material: Nitrile rubber. Form factor: Ambidextrous, beaded cuff, powder-free. Sizes: XS, S, M, L, XL, XXL. Standards: ASTM D6319 (dimensions/physical properties), ASTM D5151 (watertight), ASTM D6124 (residual powder), ASTM D6978 (chemotherapy permeation). Biocompatibility: ISO 10993-10 (irritation/sensitization), ISO 10993-11 (systemic toxicity). Sterilization: Non-sterile.

Indications for Use

Indicated for use as a disposable, non-sterile, ambidextrous patient examination glove to prevent contamination between patient and examiner. The chemotherapy-labeled variant is indicated for use during handling of specific chemotherapy drugs as tested per ASTM D6978-05 (2019).

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

• SkyBreeze Zero Nitrile Powder-Free Exam Gloves (K182851)

Submission Summary (Full Text)

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

May 12, 2022

KL-Kepong Rubber Products SDN. BHD. % Kewin Tham Official Correspondent mdi Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021

Re: K220118

Trade/Device Name: Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LZC Dated: April 6, 2022 Received: April 11, 2022

Dear Kewin Tham:

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 ([e-mail]) or phone [phone] 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) K220118

Device Name Nitrile Powder Free Examination Gloves

Indications for Use (Describe)

A 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.

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

## K220118

## Date Summary Prepared: 12 May 2022

#### 1. Submitter's Identification:

KL-KEPONG RUBBER PRODUCTS SDN. BHD. Lot 134905, ¾ Mile Off Jalan Bercham, Kawasan Perindustrian Bercham, 31400 Ipoh, Perak, Malaysia

Contact: Michael Ng Seng Chuenq Tel: [phone]

#### 2. Name of the Devices:

Name of Device Candidate #1: Nitrile Powder Free Examination Gloves

# Name of Device Candidate #2:

Chemotherapy Nitrile Powder Free Examination Gloves

#### 3. Regulatory Information:

### For Device Candidate #1:

Requlation Name: Regulatory Class: Product Code: Regulation Number: Panel:

Polymer Patient Examination Glove Class I LZA 21 CFR 880.6250 General Hospital

### For Device Candidate #2:

Requlation Name: Regulatory Class: Product Code: Regulation Number: Panel:

Patient Examination Glove, Specialty Class I LZC 21 CFR 880.6250 General Hospital

#### 4. Predicate Device Information:

### For both Device Candidate #1 and Device Candidate #2:

Predicate Device: K182851

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| Trade/Device Name: | SkyBreeze Zero Nitrile Powder-Free Exam Gloves Tested<br>for Use with Chemotherapy Drugs |
|-----------------------------|------------------------------------------------------------------------------------------|
| Device Classification Name: | Patient Examination Glove |
| Device Class: | Class I |
| Product Code: | LZA, LZC |
| Applicant Name: | O&M Halyard, Inc. |

#### 5. Device Description:

Two subject devices are bundled into this 510(k) submission. The subject devices, the Nitrile Powder Free Examination Gloves and the Chemotherapy Nitrile Powder Free Examination Gloves, are single use, disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff and tested for use with chemotherapy drugs. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These qloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state.

The two subject devices proposed are identical in terms of sizes, materials, color, specification, and process. The only difference between the two is the chemotherapy druq labeling.

#### 6. Indications for Use:

### 1. Device Candidate #1: Nitrile Powder Free Examination Gloves

A 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.

- 2. Device Candidate #2: Chemotherapy Nitrile Powder Free Examination Gloves
A patient examination qlove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs as per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:

Carmustine (BCNU) 3.3 mg/ml: no breakthrough up to 32.9 minutes Cisplatin 1.0mg/ml: no breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) 20.0mg/ml: no breakthrough up to 240 minutes Dacarbazine 10.0mg/ml: no breakthrough up to 240 minutes Doxorubicin HCl 2.0mq/ml: no breakthrough up to 240 minutes Etoposide 20.0mg/ml: no breakthrough up to 240 minutes Fluorouracil 50.0mg/ml: no breakthrough up to 240 minutes Ifosfamide 50.0mg/ml: no breakthrough up to 240 minutes Methotrexate 25.0mg/ml: no breakthrough up to 240 minutes

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Mitomycin C 0.5mg/ml: no breakthrough up to 240 minutes Paclitaxel 6.0mg/ml: no breakthrough up to 240 minutes ThioTepa 10.0mg/ml: no breakthrough up to 35.7 minutes Vincristine Sulfate 1.0mg/ml: no breakthrough up to 240 minutes

Not recommended for use: Carmustine (BCNU) 3.3mg/ml, ThioTepa 10.0mg/ml

#### 7. Comparison to the 510(k) Cleared Devices (Predicate Devices):

| COMPARISON<br>CRITERIA | Subject Device | Predicate Device<br>(K182851) | COMPARISON<br>RESULTS |
|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Manufacturer | KL-Kepong Rubber<br>Products Sdn. Bhd. | O&M Halyard, Inc. | N/A |
| Device Classification<br>Name/ Regulation<br>Number | Patient Examination<br>Glove/ 21 CFR Part<br>880.6250 | Patient Examination<br>Glove/ 21 CFR Part<br>880.6250 | Similar |
| Product Code | LZA, LZC | LZA, LZC | Similar |
| Intended Use /<br>Indications for Use | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that<br>is worn on the<br>examiner's hand to<br>prevent contamination<br>between patient and<br>examiner. These<br>gloves were tested for<br>use with<br>chemotherapy drugs<br>as per ASTM D6978-<br>05 (2019) Standard<br>Practice for<br>Assessment of<br>Resistance of Medical<br>Gloves to Permeation<br>by Chemotherapy<br>Drugs. | The SkyBreeze Zero<br>Nitrile Powder-Free<br>Exam Glove is a<br>disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's hand<br>to prevent<br>contamination between<br>patient and examiner.<br>These gloves were<br>tested for use with<br>chemotherapy drugs<br>listed on the label | Similar |
| Material | Nitrile | Nitrile | Similar |
| Powdered or powder<br>free | Powder free | Powder free | Similar |
| Single use | Yes | Yes | Similar |
| Sterility | Non-sterile | Non-sterile | Similar |
| Dimensions | Meet requirements of<br>ASTM D6319 | Meet requirements of<br>ASTM D6319 | Similar |
| Physical properties | Meet requirements of | Meet requirements of | Similar |
| | ASTM D6319 | ASTM D6319 | |
| Freedom from Holes | Meet requirements of<br>ASTM D5151 | Meet requirements of<br>ASTM D5151 | Similar |
| Residual Powder | Meet requirements of<br>ASTM D6124 | Meet requirements of<br>ASTM D6124 | Similar |
| Chemotherapy Drugs<br>Permeation Test as per<br>ASTM D6978, minimum<br>breakthrough detection<br>time in minutes (for<br>Device Candidate #2) | Meets acceptance<br>criteria for 11 drugs | Meets acceptance<br>criteria for 10 drugs | Minimum 9 drugs<br>meeting<br>acceptance<br>criteria.<br>Similar |
| | Carmustine (BCNU),<br>3.3 mg/ml: 32.9 | Carmustine (BCNU),<br>3.3 mg/ml: 18.6 | <240, same |
| | Cisplatin, 1.0mg/ml:<br>>240 | Cisplatin, 1.0mg/ml:<br>>240 | Same |
| | Cyclophosphamide<br>(Cytoxan), 20.0mg/ml:<br>>240 | Cyclophosphamide<br>(Cytoxan), 20.0mg/ml:<br>>240 | Same |
| | Dacarbazine,<br>10.0mg/ml: >240 | Dacarbazine,<br>10.0mg/ml: >240 | Same |
| | Doxorubicin HCI,<br>2.0mg/ml: >240 | Doxorubicin HCI,<br>2.0mg/ml: >240 | Same |
| | Etoposide, 20.0mg/ml:<br>>240 | Etoposide, 20.0mg/ml:<br>>240 | Same |
| | Fluorouracil,<br>50.0mg/ml: >240 | Fluorouracil,<br>50.0mg/ml: >240 | Same |
| | Ifosfamide,<br>50.0mg/ml: >240 | Ifosfamide, 50.0mg/ml:<br>>240 | Same |
| | Methotrexate,<br>25.0mg/ml: >240 | Methotrexate,<br>25.0mg/ml: Not tested | Additional test for<br>subject device |
| | Mitomycin C,<br>0.5mg/ml: >240 | Mitomycin C, 0.5mg/ml:<br>Not tested | Additional test for<br>subject device |
| | Paclitaxel, 6.0mg/ml:<br>>240 | Paclitaxel, 6.0mg/ml:<br>>240 | Same |
| | ThioTepa, 10.0mg/ml:<br>35.7 | ThioTepa, 10.0mg/ml:<br>48.3 | <240, same |
| | Vincristine Sulfate,<br>1.0mg/ml: >240 | Vincristine Sulfate,<br>1.0mg/ml: >240 | Same |
| | Mitoxantrone,<br>2.0mg/ml: Not tested | Mitoxantrone,<br>2.0mg/ml: >240 | Not to be claimed |
| Biocompatibility<br>ISO 10993-10<br>Biological Evaluation<br>of Medical Devices -<br>Part 10: Tests for<br>Irritation and Skin<br>Sensitization | Under the conditions<br>of the study, not an<br>irritant and not a skin<br>sensitizer | Under the conditions of<br>the study, not primary<br>skin irritant;<br>Under the conditions of<br>the study, not a contact<br>sensitizer | Similar |
| Biocompatibility<br>ISO 10993-11<br>Biological Evaluation of<br>Medical Devices- Part<br>11: Tests for Systemic<br>Toxicity | Under the conditions<br>of the study, the test<br>article is considered<br>non-toxic | The test article was<br>considered non-toxic | Similar |

## Table 1: Comparison to Predicate Device for both Device Candidate #1 and Device Candidate #2:

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### 8. Summary of Non-Clinical Tests Performed for Determination of Substantial Equivalence for both Device Candidate #1 and Device Candidate #2 are as follows:

| Table 2: Summary Non-Clinical Tests | | |
|-------------------------------------|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Standard | Testing | Requirements are met |
| ASTM<br>D5151 | Watertight Test<br>(Freedom from<br>Holes) | Pass Inspection Level G1, AQL 2.5 |
| ASTM<br>D6319 | Dimensions | Length<br>XS: min 220mm<br>S: min 220mm<br>M: min 230mm<br>L: min 230mm<br>XL: min 230mm<br>XXL: min 230mm<br>Palm Width<br>XS: 70 ± 10mm<br>S: 80 ± 10mm<br>M: 95 ± 10mm<br>L: 110 ± 10mm<br>XL: 120 ± 10mm<br>XXL: 130 ± 10mm<br>Thickness<br>Finger: min 0.05mm<br>Palm: min 0.05mm |
| ASTM | Physical | Before Aging: |

# Table 2: Summary Non-Clinical Tests

T

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| D6319 | Properties | Tensile strength: min 14MPa<br>Ultimate elongation: min 500% |
|---------------|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | After Aging:<br>Tensile strength: min 14MPa<br>Ultimate elongation: min 400% |
| ASTM<br>D6124 | Powder Amount | Residual powder <2.0mg/glove |
| ASTM<br>D6978 | Chemotherapy<br>Drugs<br>Permeation Test | An assessment is made based on the<br>permeation (breakthrough) of 11<br>chemotherapy drugs through the<br>glove material over a certain period of<br>time (See Table 1) |

## Table 3: Summary of Biocompatibility Tests

| ISO<br>10993-10 | Biological<br>Evaluation on<br>Medical Devices-<br>Part 10: Test for<br>Irritation and Skin<br>Sensitization | Pass primary skin irritation test and<br>dermal sensitization test |
|-----------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| ISO<br>10993-11 | Biological<br>Evaluation of<br>Medical Devices-<br>Part 11: Tests for<br>Systemic Toxicity | Pass systemic toxicity test |

The following National and International Standards were utilized for testing the subject device:

| ASTM D6319-19 | Standard Specification for Nitrile Examination<br>Gloves for Medical Application |
|---------------|------------------------------------------------------------------------------------------------------------|
| ASTM D5151-19 | Standard Test Method for detection of Holes in<br>Medical Gloves |
| ASTM D6124-06 | Standard Test Method for Residual Powder on<br>Medical Gloves |
| ASTM D6978-05 | Standard Practice for Assessment of Resistance of<br>Medical Gloves to Permeation by Chemotherapy<br>Drugs |
| ISO 10993-10 | Biological Evaluation on Medical Devices- Part 10:<br>Test for Irritation and Skin Sensitization |
| ISO 10993-11 | Biological Evaluation of Medical Devices- Part 11:<br>Tests for Systemic Toxicity |

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our

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conclusion that Nitrile Powder Free Examination Gloves/Chemotherapy Nitrile Powder Free Examination Gloves tested met all relevant requirements of the aforementioned tests.

### 9. Summary of Clinical Tests Performed for both Device Candidate #1 and Device Candidate #2:

Not applicable. Clinical data is not required for marketing clearance of patient examination gloves.

#### 10. Conclusions for both Device Candidate #1 and Device Candidate #2:

The conclusion drawn from the non-Clinical tests demonstrates that the subject devices, the Nitrile Powder Free Examination Gloves and the Chemotherapy Nitrile Powder Free Examination Gloves are as safe, as effective, and perform as well as or better than the legally marketed predicate device cleared under K182851.