Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

K180476 · Comfort Rubber Gloves Industries Sdn. Bhd. · LZC · May 15, 2018 · General Hospital

Device Facts

• Record ID: K180476
• Device Name: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
• Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.
• Product Code: LZC · General Hospital
• Decision Date: May 15, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.

Device Story

Disposable, non-sterile, powder-free nitrile examination glove; intended for use by healthcare professionals to prevent cross-contamination and provide barrier protection against chemotherapy drugs. Device functions as a physical barrier. Performance validated via ASTM D6978-05 permeation testing for specific chemotherapy agents. Used in clinical settings; worn by examiners. Provides protection against chemical exposure; breakthrough times vary by drug agent.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via ASTM D6319-10(2015) for physical properties/dimensions, ASTM D6124-06(2011) for powder content, ASTM D5151 for watertightness, and ASTM D6978-05 for chemotherapy drug permeation. Biocompatibility testing performed per ISO 10993-10 (irritation/sensitization) and ISO 10993-5 (cytotoxicity/systemic toxicity).

Technological Characteristics

Material: Nitrile. Form factor: Disposable, powder-free, non-sterile examination glove. Standards: ASTM D6319-10(2015) (dimensions/physical properties), ASTM D6124-06(2011) (powder content), ASTM D6978-05 (chemotherapy permeation), ISO 10993 (biocompatibility). Dimensions: Min 240mm length, min 0.05mm thickness. Color: Green.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between examiner and patient and to provide protection against exposure to specific chemotherapy drugs.

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

• Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue) (K162405)
• Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White) (K162405)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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 15, 2018

Comfort Rubber Gloves Industries Sdn. Bhd. Chan Yew Men QA & QMS Manager Lot 821, Jalan Matang 34750 Matang, Perak Malyasia

Re: K180476

Trade/Device Name: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC, LZA Dated: February 12, 2018 Received: February 22, 2018

Dear Chan Yew Men:

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. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation 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)

### K180476

### Device Name

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green)

Indications for Use (Describe)

The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use chemotherapy drugs. Tested drugs are as follows:

| | Average Breakthrough Detection Time (minutes) |
|-------------------------------------|-----------------------------------------------|
| Cisplatin 1.0 mg/ml | ≥ 240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | ≥ 240 |
| Dacarbazine (DTIC) 10.0 mg/ml | ≥ 240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | ≥ 240 |
| Etoposide (Toposar) 20.0 mg/ml | ≥ 240 |
| Fluorouracil 50.0 mg/ml | ≥ 240 |
| Paclitaxel (Taxol) 6.0 mg/ml | ≥ 240 |

Please note that the following drugs have extremely low permeation time for

*Carmustine (BCNU) 3.3mg.ml - 23.4 (mins)

*Thiotepa 10.0 mg/ml - 16.2 (mins)

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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### ATTACHMENT 2

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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## 510(k) SUMMARY

### POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (GREEN)

#### 1.0 Submitter:

| Name | Comfort Rubber Gloves Industries Sdn. Bhd. |
|----------------------|-----------------------------------------------------------------------|
| Address | Lot 821, Jalan Matang,<br>34750 Matang, Perak, Malaysia.<br>Malaysia. |
| Phone No. | 605-847 2777 |
| Fax No. | 605-847 9108 |
| Contact Person | Chan Yew Men (Mr.) |
| Date of Preparation: | April 17, 2018 |

#### 2.0 Name of the Device

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green)

| Common Name | : | Patient Examination Gloves |
|---------------------|---|------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | : | Patient Examination Gloves (21 CFR 880.6250 product<br>code LZA)<br>Patient Examination Gloves Specialty (21 CFR 880.6250<br>product code LZC) |
| 510(K) Number | : | K180476 |

#### 3.0 Identification of The Legally Marketed Devices That equivalency is claimed:

Predicate

Device Name : Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue) Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White)

- Company : Comfort Rubber Gloves Industries Sdn. Bhd.
: K162405 510(K) No.

#### 4.0 Description of the Device:

The proposed device is the Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green). The proposed device is for single use and is provided non-sterile. The device meets the requirements for dimensions, physical properties, and thickness in ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application. The device accomplishes its intended function by creating a

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physical barrier between the examiner and patient and creates a barrier for the chemotherapy drugs listed in the Indications for Use.

#### 5.0 Indication for Use of the Device

The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) are a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs. Tested drugs are as follows:

| | Average Breakthrough Detection Time (minutes) |
|-------------------------------------|-----------------------------------------------|
| Cisplatin 1.0 mg/ml | ≥ 240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | ≥ 240 |
| Dacarbazine (DTIC) 10.0 mg/ml | ≥ 240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | ≥ 240 |
| Etoposide (Toposar) 20.0 mg/ml | ≥ 240 |
| Fluorouracil 50.0 mg/ml | ≥ 240 |
| Paclitaxel (Taxol) 6.0 mg/ml | ≥ 240 |

Please note that the following drugs have extremely low permeation time for *Carmustine (BCNU) 3.3 mg/ml - 23.4 (mins) *Thiotepa 10.0 mg/ml - 16.2 (mins)

#### 6.0 Summary of the Technological Characteristics of the Device:

The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) are summarized with the following technological characteristics compared to ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards as shown in Table 1.

The chemotherapy claim is similar to the Predicate, which has a qloves thickness which complies with the ASTM standard ASTM D6319 - 10(2015): Standard Specification for Nitrile Examination Gloves for Medical Application.

| CHARACTERISTIC | STANDARDS | DEVICE PERFORMANCE | | Comparison |
|------------------------------|--------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|------------|
| Manufacturer(s) | | Comfort Rubber<br>Gloves Industries<br>Sdn. Bhd | Comfort Rubber<br>Gloves Industries<br>Sdn. Bhd | Same |
| 510(k) number | | K162405 | K180476 | |
| Dimension | ASTM D6319 -<br>10(2015) | Length-Min 240mm<br>Thickness palm and<br>finger- Min 0.05mm | Length-Min 240mm<br>Thickness palm and<br>finger- Min 0.05mm | Same |
| Physical Properties | ASTM D6319 -<br>10(2015) | Meets | Meets | Same |
| Thickness - Finger<br>- Palm | ASTM D6319 -<br>10(2015) | Meets | Meets | Same |
| Powder Content | ASTM D6124 -<br>06(2011)<br>(≤ 2 mg/glove) | Meets | Meets | Same |

### Comparison of technological characteristics with the predicate device

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| | CHARACTERISTIC | STANDARDS | DEVICE PERFORMANCE | | |
|--|--------------------------------------|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| | | | Predicate | Current | Comparison |
| | | | Powder Free Nitrile<br>Examination Gloves<br>Tested for Use with<br>Chemotherapy<br>Drugs Labeling<br>Claim (Blue) | Powder Free Nitrile<br>Examination Gloves<br>Tested for Use with<br>Chemotherapy<br>Drugs Labeling<br>Claim (Green) | |
| | Chemotherapy Drug<br>Permeation Test | ASTM D6978-05 | | | |
| | Test Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time<br>(min) | | |
| | *Carmustine (BCNU) | 3.3 mg/ml | 18.2 | 23.4 | |
| | Cisplatin | 1.0 mg/ml | >240 | >240 | |
| | Cyclophosphamide (Cytoxan) | 20 mg/ml | >240 | >240 | |
| | Dacarbazine (DTIC) | 10.0 mg/ml | >240 | >240 | Similar - The |
| | Doxorubicin Hydrochloride | 2.0 mg/ml | >240 | >240 | chemotherapy |
| | Etoposide (Toposar) | 20.0 mg/ml | >240 | >240 | drugs tested |
| | Fluorouracil | 50.0 mg/ml | >240 | >240 | have similar |
| | Paclitaxel (Taxol) | 6.0 mg/ml | >240 | >240 | breakthrough |
| | *Thiotepa | 10.0 mg/ml | 57.3 | 16.2 | detection |
| | Warning Statement | | * WARNING:<br>Please note that the<br>following drugs have<br>extremely low<br>permeation times<br>Carmustine (BCNU):<br>18.2 minutes and<br>Thiotepa: 57.3<br>minutes. | * WARNING:<br>Please note that the<br>following drugs have<br>extremely low<br>permeation times<br>Carmustine (BCNU):<br>23.4 minutes and<br>Thiotepa: 16.2<br>minutes. | times; the<br>drugs with low<br>permeation<br>times are the<br>same. |

| | | DEVICE PERFORMANCE | | |
|--------------------------------------|---------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------|
| CHARACTERISTIC | STANDARDS | Predicate | Current | Comparison |
| | | Powder Free Nitrile<br>Examination Gloves<br>Tested for Use with<br>Chemotherapy<br>Drugs Labeling<br>Claim (White) | Powder Free Nitrile<br>Examination Gloves<br>Tested for Use with<br>Chemotherapy<br>Drugs Labeling<br>Claim (Green) | |
| Chemotherapy Drug<br>Permeation Test | ASTM D6978-05 | | | |
| Test Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time<br>(min) | | |
| *Carmustine (BCNU) | 3.3 mg/ml | 24.0 | 23.4 | Similar - The<br>chemotherapy |
| Cisplatin | 1.0 mg/ml | >240 | >240 | chemotherapy |
| Cyclophosphamide (Cytoxan) | 20 mg/ml | >240 | >240 | drugs tested |
| Dacarbazine (DTIC) | 10.0 mg/ml | >240 | >240 | have similar |
| Doxorubicin Hydrochloride | 2.0 mg/ml | >240 | >240 | breakthrough |
| Etoposide (Toposar) | 20.0 mg/ml | >240 | >240 | detection |
| Fluorouracil | 50.0 mg/ml | >240 | >240 | times; the |
| Paclitaxel (Taxol) | 6.0 mg/ml | >240 | >240 | drugs with low |
| *Thiotepa | 10.0 mg/ml | 54.9 | 16.2 | permeation |

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| | Please note that the<br>following drugs have<br>extremely low<br>permeation times<br>Carmustine (BCNU):<br>24.0 minutes and<br>Thiotepa: 54.9<br>minutes. | Please note that the<br>following drugs have<br>extremely low<br>permeation times<br>Carmustine (BCNU):<br>23.4 minutes and<br>Thiotepa: 16.2<br>minutes. | same. |
|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------|

| CHARACTERISTIC | STANDARDS | DEVICE PERFORMANCE | | Comparison |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | Predicate | Current | |
| Biocompatibility:<br>Primary Skin Irritation | ISO 10993-<br>10:2010<br>Biological<br>evaluation of<br>medical devices --<br>Part 10: Tests for<br>irritation and skin<br>sensitization | Passes<br>Under the conditions<br>of the study, the<br>subject device is non-<br>irritating | Passes<br>Under the conditions<br>of the study, the<br>subject device is non-<br>irritating | Same |
| Biocompatibility:<br>Dermal Sensitization | ISO 10993-<br>10:2010<br>Biological<br>evaluation of<br>medical devices --<br>Part 10: Tests for<br>irritation and skin<br>sensitization | Passes<br>Under the conditions<br>of the study, the<br>subject device is non-<br>sensitization | Passes<br>Under the conditions<br>of the study, the<br>subject device is non-<br>sensitization | Same |
| Biocompatibility:<br>Cytotoxicity and acute<br>systemic toxicity | ISO 10993-5:2009<br>Biological<br>evaluation of<br>medical devices --<br>Part 5: Tests for <i>in vitro</i> cytotoxicity<br>ISO 10993-5:2017<br>Biological<br>evaluation of<br>medical devices --<br>Part 5: Tests for<br>systemic toxicity | N/A | Passes<br>Certificate of Analysis<br>for the color imparting<br>compound indicates<br>that the compound<br>meets technical<br>specifications, is non-<br>cytotoxic, and is not<br>systemically toxic. | Different |
| Watertight (1000ml) | 21 CFR 800.20<br>ASTM D5151 | Passes | Passes | Same |
| Indication for Use | | The Powder Free<br>Nitrile Examination<br>Gloves Tested for<br>Use with<br>Chemotherapy Drugs<br>Labeling Claim (Blue)<br>is a specialty medical<br>glove which is a<br>disposable device<br>intended for medical<br>purpose that is worn<br>on the examiner's<br>hand or finger to<br>prevent | The Powder Free<br>Nitrile Examination<br>Gloves Tested for<br>Use with<br>Chemotherapy Drugs<br>Labeling Claim<br>(Green) is a specialty<br>medical glove which<br>is a disposable<br>device intended for<br>medical purpose that<br>is worn on the<br>examiner's hand or<br>finger | Similar |

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| contamination<br>between examiner<br>and patient. In<br>addition these gloves<br>are worn to protect<br>the wearer against<br>exposure to<br>chemotherapy drugs.<br>Tested<br>chemotherapy drugs<br>are as follows: | contamination<br>between examiner<br>and patient. In<br>addition these gloves<br>are worn to protect<br>the wearer against<br>exposure to<br>chemotherapy drugs.<br>Tested chemotherapy<br>drugs are as follows: | | examiner's hand or<br>finger to prevent<br>contamination<br>between examiner<br>and patient. In<br>addition these gloves<br>are worn to protect<br>the wearer against<br>exposure to<br>chemotherapy drugs.<br>Tested<br>chemotherapy drugs<br>are as follows: | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Average<br>Breakthrough<br>Detection Time<br>(minutes) | Average<br>Breakthrough<br>Detection Time<br>(minutes) | | Average<br>Breakthrough<br>Detection Time<br>(minutes) | |
| Cisplatin, 1.0 mg/ml -<br>≥ 240<br>Cyclophosphamide<br>(Cytoxan), 20.0<br>mg/ml - ≥ 240<br>Dacarbazine (DTIC),<br>10.0 mg/ml - ≥ 240<br>Doxorubicin<br>Hydrochloride, 2.0<br>mg/ml - ≥ 240<br>Etoposide (Toposar),<br>20.0 mg/ml - ≥ 240<br>Fluorouracil, 50.0<br>mg/ml - ≥ 240<br>Paclitaxel (Taxol), 6.0<br>mg/ml<br>- ≥ 240 | Cisplatin, 1.0 mg/ml -<br>≥ 240<br>Cyclophosphamide<br>(Cytoxan), 20.0<br>mg/ml - ≥ 240<br>Dacarbazine (DTIC),<br>10.0 mg/ml - ≥ 240<br>Doxorubicin<br>Hydrochloride, 2.0<br>mg/ml - ≥ 240<br>Etoposide (Toposar),<br>20.0 mg/ml - ≥ 240<br>Fluorouracil, 50.0<br>mg/ml - ≥ 240<br>Paclitaxel (Taxol), 6.0<br>mg/ml<br>- ≥ 240 | | Cisplatin, 1.0 mg/ml -<br>$\ge$ 240<br>Cyclophosphamide<br>(Cytoxan), 20.0<br>mg/ml - $\ge$ 240<br>Dacarbazine (DTIC),<br>10.0 mg/ml - $\ge$ 240<br>Doxorubicin<br>Hydrochloride, 2.0<br>mg/ml - $\ge$ 240<br>Etoposide (Toposar),<br>20.0 mg/ml - $\ge$ 240<br>Fluorouracil, 50.0<br>mg/ml - $\ge$ 240<br>Paclitaxel (Taxol), 6.0<br>mg/ml<br>- $\ge$ 240 | |
| Please note that the<br>following drugs have<br>extremely low<br>permeation time for: | Please note that the<br>following drugs have<br>extremely low<br>permeation time for: | | Please note that the<br>following drugs have<br>extremely low<br>permeation time for: | |
| Carmustine (BCNU)<br>3.3mg/ml - 18.2<br>(mins)<br>Thiotepa 10.0 mg/ml<br>- 57.3 (mins) | Carmustine (BCNU)<br>3.3mg/ml - 23.4<br>(mins)<br>Thiotepa 10.0 mg/ml<br>- 16.2 (mins) | | Carmustine (BCNU)<br>3.3mg/ml - 24.0<br>(mins)<br>Thiotepa 10.0 mg/ml<br>- 54.9 (mins) | |
| The Powder Free<br>Nitrile Examination<br>Gloves Tested for<br>Use with<br>Chemotherapy Drugs<br>Labeling Claim<br>(White) is a specialty<br>medical glove which<br>is a disposable<br>device intended for<br>medical purpose that<br>is worn on the | | | | |

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| CHARACTERISTIC | STANDARDS | DEVICE PERFORMANCE | | |
|----------------|------------------------------------------------|-----------------------------------------|-----------------------------------------|------------|
| | | Predicate | Current | Comparison |
| Material | ASTM D6319 -<br>10(2015) | Nitrile | Nitrile | Same |
| Color | - | Blue or White | Green | Different |
| Size | Medical Glove<br>Guidance Manual<br>- Labeling | Extra Small<br>Small<br>Medium<br>Large | Extra Small<br>Small<br>Medium<br>Large | Same |

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| | | Extra Large | Extra Large | |
|------------|------------------------------------------------|-------------|-------------|------|
| Single Use | Medical Glove<br>Guidance Manual<br>– Labeling | Single Use | Single Use | Same |

#### 7.0 Summary of Non-Clinical Performance Data

The device and the predicate share the same indication for use, same base polymeric material, same specifications for thickness and length, similar permeation rate for chemotherapy drugs, similar labeling properties, biocompatibility per ISO 10993-1, water tight test results, and are powder free.

#### 8.0 Summary of Clinical Performance Data

Clinical data is not needed for the intended use for this device.

#### 9.0 Conclusion

Based on the Indication for Use, technological characteristics, and non-clinical performance data, the Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) (K180476) is as safe, as effective, and performs as well as the legally marketed predicate device (K162405).