Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs

K190403 · Ever Global (Vietnam) Enterprise Corporation · LZA · Sep 6, 2019 · General Hospital

Device Facts

• Record ID: K190403
• Device Name: Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs
• Applicant: Ever Global (Vietnam) Enterprise Corporation
• Product Code: LZA · General Hospital
• Decision Date: Sep 6, 2019
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:

Device Story

Disposable nitrile examination gloves; non-sterile; intended as patient-examiner barrier. Device provides single-use protection; tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Used in clinical settings by healthcare professionals. Output is physical barrier protection; aids in infection control and clinician safety during chemotherapy drug handling.

Clinical Evidence

No clinical data. Bench testing only. Testing included dimensions, physical properties (tensile strength, elongation), freedom from pinholes (21 CFR 800.20), powder residual, biocompatibility (ISO 10993-10, ISO 10993-5), and chemotherapy drug permeation (ASTM D6978-05).

Technological Characteristics

Nitrile compound; non-sterile; powder-free. Dimensions and physical properties comply with ASTM D6319-10. Biocompatibility per ISO 10993-10 and ISO 10993-5. Chemotherapy permeation testing per ASTM D6978-05.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hands or fingers to prevent contamination between patient and examiner. Tested for use with 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

• KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) (K171171)

Reference Devices

• K171104

Submission Summary (Full Text)

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

September 6, 2019

Ever Global (Vietnam) Enterprise Corporation % Albert T.w. Li Official Third Party Correspondent Center For Measurement Standards Of Industrial Bldg. 16, 321 Kuang Fu Rd,sec2 Hsinchu, Tw

Re: K190403

Trade/Device Name: Disposable Powder Free Nitrile Examination Glove, White Color, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drug Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I Product Code: LZA, LZC Dated: August 27, 2019 Received: September 3, 2019

Dear Albert T.w. Li:

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/cfpmp/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

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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 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,

Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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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No. 1 Road, Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, Vietnam

Tel: [phone]

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known)

#### K190403

#### Device Name

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs

Indications for Use (Describe)

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:

| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time ( Min) |
|-------------------------------------------|--------------------------------------------|
| 1. Carmustine (BCNU), 3.3 mg/ml | 6.2 |
| 2. Thiotepa, 10.0 mg/ml | 38.8 |
| 3. Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 |
| 4. Cisplatin, 1.0 mg/ml | ≥ 240 |
| 5. Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 |
| 6. Fluorouracil, 50.0 mg/ml | ≥ 240 |
| 7. Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 |
| 8. Etoposide (Toposar), 20.0 mg/ml | ≥ 240 |
| 9. Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 |

The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permention time: Carmustine (BCNU), 3.3 mg/ml 6.2 minutes Thiotepa, 10.0 mg/ml 38.8 minutes

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

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

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

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No. 1 Road, Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, Vietnam

Tel: [phone]

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

### 510(k) Number (if known)

K190403

#### Device Name

Disposable Powder Free Nitrile Examination Glove, White Color, Tested For Use With Chemotherapy Drugs

Indications for Use (Describe)

A patient exammation gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:

| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time ( Min) |
|-------------------------------------------|--------------------------------------------|
| 1. Carmustine (BCNU), 3.3 mg/ml | 22.8 |
| 2. Thiotepa, 10.0 mg/ml | 54.6 |
| 3. Cyclophosphamide (Cytoxan), 20.0 mg/ml | $\geq$ 240 |
| 4. Cisplatin, 1.0 mg/ml | $\geq$ 240 |
| 5. Doxorubicin Hydrochloride, 2.0 mg/ml | $\geq$ 240 |
| 6. Fluorouracil, 50.0 mg/ml | $\geq$ 240 |
| 7. Dacarbazine (DTIC), 10.0 mg/ml | $\geq$ 240 |
| 8. Etoposide (Toposar), 20.0 mg/ml | $\geq$ 240 |
| 9. Paclitaxel (Taxol), 6.0 mg/ml | $\geq$ 240 |

The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time: Carmustine (BCNU), 3.3 mg/ml 22.8 minutes Thiotepa, 10.0 mg/ml 54.6 minutes

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

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No. 1 Road, Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, Vietnam

Tel: [phone]

| 510(k) SUMMARY | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K190403 | |
| Premarket Notification [510(k)] Summary | |
| 1.0 Submitter: | |
| Submitter's name : | Ever Global (Vietnam) Enterprise Corporation |
| Submitter's address : | No. 1 Road, Long Thanh Industrial Zone, Taman Village, Long Thanh District,<br>Dong Nai Province, Vietnam |
| Phone number : | 84-61-3514022 |
| Fax number : | 84 -61-3514023 |
| Name of contact person: | Jerry Lin |
| Summary Preparation Date: | September 6, 2019 |
| 2.0 Name of the Device | |
| Proprietary/Trade name: | Disposable Powder Free Nitrile Examination Glove, White Color, Tested For<br>Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination<br>Glove, Blue Color, Tested For Use With Chemotherapy Drugs |
| Common Name: | Nitrile Examination Gloves |
| Classification Name: | Patient Examination Glove |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 880.6250 |
| Product Code: | LZA, LZC |
| 3.0 Predicate device | |
| Device Name: | KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for<br>Use with Chemotherapy Drugs (Blue, Black) |
| Company name: | Koon Seng Sdn. Bhd. |
| 510(K) Number: | K171171 |
| 4.0 Device Description: | |
| Disposable Powder Free Nitrile Examination Glove, White/Blue Color, Tested For Use With Chemotherapy Drugs is a<br>patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle<br>operation of the medical device to provide single use barrier protection for the wearer and the device meets all the<br>requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification | |

for Nitrile Examination Gloves.

#### 5.0 Indication for use:

#### Disposable Powder Free Nitrile Examination Glove, White Color, Tested For Use With Chemotherapy Drugs

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:

| | Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Min.) |
|----|------------------------------------------|--------------------------------------------|
| 1. | Carmustine (BCNU), 3.3 mg/ml | 22.8 |
| 2. | Thiotepa, 10.0 mg/ml | 54.6 |
| 3. | Cyclophosphamide (Cytoxan), 20.0 mg/ml | 2 240 |
| 4. | Cisplatin, 1.0 mg/ml | 2 240 |
| 5. | Doxorubicin Hydrochloride, 2.0 mg/ml | 2 240 |
| 6. | Fluorouracil, 50.0 mg/ml | 2 240 |
| 7. | Dacarbazine (DTIC), 10.0 mg/ml | 2 240 |
| 8. | Etoposide (Toposar), 20.0 mg/ml | 2 240 |
| 9. | Paclitaxel (Taxol), 6.0 mg/ml | 2 240 |

Table 5.1 Nitrile white color test for 9 chemotherapy drugs

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No. 1 Road, Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, Vietnam

Tel: [phone]

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:

| Table 5.2 Nitrile blue color test for 9 chemotherapy drugs | | |
|------------------------------------------------------------|------------------------------------------|--------------------------------------------|
| | Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Min.) |
| 1. | Carmustine (BCNU), 3.3 mg/ml | 6.2 |
| 2. | Thiotepa, 10.0 mg/ml | 38.8 |
| 3. | Cyclophosphamide (Cytoxan), 20.0 mg/ml | 2 240 |
| 4. | Dacarbazine (DTIC), 10.0 mg/ml | 2 240 |
| 5. | Doxorubicin Hydrochloride, 2.0 mg/ml | 2 240 |
| 6. | Etoposide (Toposar), 20.0 mg/ml | 2 240 |
| 7. | Fluorouracil, 50.0 mg/ml | 2 240 |
| 8. | Paclitaxel (Taxol), 6.0 mg/ml | 2 240 |
| 9. | Cisplatin, 1.0 mg/ml | 2 240 |

### Table 5 2 Nitrile blue color test for 9 chemotherapy drugs

#### 6.0 Technological Characteristics:

### Shown below is a technological comparison of the subject device(K190403) with the predicate device (K171171)

| Device<br>Characteristic | Predicate Device (K171171) | Proposed Device (K190403) | Comparison |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | KS Medicare Powder Free Nitrile<br>Examination Gloves, Non-sterile, Tested for<br>Use with Chemotherapy Drugs (Blue, Black) | Disposable Powder Free Nitrile Examination<br>Glove, White/Blue Color, Tested For Use With<br>Chemotherapy Drugs | N/A |
| 510(K) No. | K171171 | K171422 | N/A |
| Product Owner | Koon Seng Sdn. Bhd. | Ever Global Enterprise Corporation | Different |
| Product Code | LZA, LZC | LZA, LZC | same |
| Regulation | 21 CFR 880.6250 | 21 CFR 880.6250 | same |
| Class | I | I | same |
| Intended Use | A powder-free patient examination glove is<br>a disposable device intended for medical<br>purposes that is worn on the examiner's<br>hand or finger to prevent contamination<br>between patient and examiner.<br>In addition, these gloves were tested for use<br>with chemotherapy drugs in accordance<br>with ASTM D6978-05 Standard Practice for<br>Assessment of Medical gloves to Permeation<br>by Chemotherapy Drugs: | The Nitrile Powder Free patient examination<br>glove is a non-sterile disposable device<br>intended for medical purposes that is worn on<br>the examiner's hands or finger to prevent<br>contamination between patient and examiner.<br>In addition, these gloves were tested for use<br>with chemotherapy drugs in accordance with<br>ASTM D6978-05 Standard Practice for<br>Assessment of Medical gloves to Permeation<br>by Chemotherapy Drugs: | similar |
| Power free | Yes | Yes | same |
| Size | Small/ Medium/Large/X Large | Small/ Medium/Large/X Large | same |
| Single Use | YES | YES | same |
| Non-Sterile | YES | YES | same |
| Dimensions-<br>Length | Complies with ASTM D6319-10<br>230 mm min | Complies with ASTM D6319-10<br>230 mm min | same |
| Dimensions<br>-Palm Width | Complies with ASTM D6319-10 | Complies with ASTM D6319-10 | same |
| | Small<br>$80\pm10$ | Small<br>$80\pm10$ | |
| | Medium<br>$95 \pm10$ | Medium<br>$95 \pm10$ | |
| | Large<br>$110\pm10$ | Large<br>$110\pm10$ | |
| | X large<br>$120 \pm10$ | X large<br>$120 \pm10$ | |
| Dimensions<br>-Thickness | Complies with ASTM D6319-10 | Complies with ASTM D6319-10 | |
| | Palm -<br>0.07 mm min. | Palm - 0.05mm min. | similar |
| | Finger -<br>0.08 mm min. | Finger - 0.05 mm min. | |
| | | {Additional comparisons a device - K171104, | |
| | | that have been approved by FDA is the same | |
| | | intended use and the thickness is lower than | |
| | | Proposed Device) | |
| | | | |
| Intended Use | A powder-free patient examination glove is | The Nitrile Powder Free patient examination | similar |
| | a disposable device intended for medical | glove is a non-sterile disposable device | |
| | purposes that is worn on the examiner's | intended for medical purposes that is worn on | |
| | hand or finger to prevent contamination | the examiner's hands or finger to prevent | |
| | between patient and examiner. | contamination between patient and examiner. | |
| | In addition, these gloves were tested for use | In addition, these gloves were tested for use | |
| | with chemotherapy drugs in accordance | with chemotherapy drugs in accordance with | |
| | with ASTM D6978-05 Standard Practice for | ASTM D6978-05 Standard Practice for | |
| | Assessment of Medical gloves to Permeation | Assessment of Medical gloves to Permeation | |
| | by Chemotherapy Drugs: | by Chemotherapy Drugs: | |
| Power free | Yes | Yes | same |
| Size | Small/ Medium/Large/X Large | Small/ Medium/Large/X Large | same |
| Single Use | YES | YES | same |
| Non-Sterile | YES | YES | same |
| Dimensions-<br>Length | Complies with ASTM D6319-10 | Complies with ASTM D6319-10 | same |
| | 230 mm min. | 230 mm min. | |
| Dimensions<br>-Palm Width | Complies with ASTM D6319-10 | Complies with ASTM D6319-10 | same |
| | Small<br>$80\pm10$ | Small<br>$80\pm10$ | |
| | Medium<br>$95 \pm10$ | Medium<br>$95 \pm10$ | |
| | Large<br>$110\pm10$ | Large<br>$110\pm10$ | |
| | X large<br>$120 \pm10$ | X large<br>$120 \pm10$ | |
| Dimensions<br>-Thickness | Complies with ASTM D6319-10 | Complies with ASTM D6319-10 | |
| | Palm -<br>0.07 mm min. | Palm - 0.05mm min. | similar |
| | Finger -<br>0.08 mm min. | Finger - 0.05 mm min. | |
| | | {Additional comparisons a device - K171104, | |
| | | that have been approved by FDA is the same…