Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims

K181066 · Eco Medi Glove Sdn. Bhd. · LZA · Sep 26, 2018 · General Hospital

Device Facts

• Record ID: K181066
• Device Name: Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims
• Applicant: Eco Medi Glove Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Sep 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by Chemotherapy Drugs.

Device Story

Disposable blue nitrile examination glove; non-sterile; powder-free. Designed for use by healthcare professionals or in clinical settings to prevent cross-contamination. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Provides barrier protection; low dermatitis potential claim supported by clinical sensitization testing. Used by clinicians to protect both patient and examiner during medical examinations and chemotherapy drug handling.

Clinical Evidence

Clinical prospective study using Modified Draize-95 test on 205 non-sensitized adult human subjects. Primary endpoint: assessment of dermal irritation and sensitization potential. Results: all negative; no clinical evidence of residual chemical additives inducing Type IV allergy. Bench testing included ASTM D6319-10, D5151-06, D6124-06, ISO 10993-10, and ISO 10993-5 (cytotoxicity).

Technological Characteristics

Material: Nitrile compound. Form: Blue, powder-free, non-sterile examination glove. Dimensions: 230mm min length, 0.05mm min thickness. Standards: ASTM D6319-10 (physical properties), ASTM D5151-06 (pinholes), ASTM D6124-06 (residual powder), ASTM D6978-05 (chemotherapy permeation), ISO 10993-5/10 (biocompatibility).

Indications for Use

Indicated for use as a disposable medical glove worn on examiner's hands or fingers to prevent cross-contamination between patient and examiner. Suitable for use with 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 (Blue) with Low Dermatitis Potential Claim with tested for use with Chemotherapy Drugs (K152542)

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.

September 26, 2018

ECO Medi Glove Sdn Bhd Suresh Kumar Quality Assurance Manager Lot 23826, Jalan Tembaga Kuning Kamunting Raya Industrial Estate Perak, 34600 My

Re: K181066

Trade/Device Name: Powder Free Examination Glove (Blue) with Low Dermatitis claim and with tested for use with Chemotherapy Drugs Claims Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: August 18, 2018 Received: August 27, 2018

Dear Suresh Kumar:

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 mav, 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 avare 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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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.

# Clarence W. Murray lii III -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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# Indications for Use

510(k) Number (if known) K181066

#### Device Name

Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with Chemotherapy Drugs Claims

#### Indications for Use (Describe)

The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by Chemotherapy Drugs.

Chemotherapy Drugs and Concentration

Minimum Breakthrough detection time in minutes(ug/cm2/minute)

| 1)Carmustine (BCNU)(3.3 mg/ml)(3,300ppm) | 12.9 |
|---------------------------------------------------|-------------------------------|
| 2)Cisplatin (1.0 mg/ml)(1,000ppm) | No breakthrough up to 240 min |
| 3)Cyclophosphamide (Cytoxan)(20 mg/ml)(20,000ppm) | No breakthrough up to 240 min |
| 4)Dacarbazine (DTIC) (10.0 mg/ml)(10,000ppm) | No breakthrough up to 240 min |
| 5)Doxorubicin Hydrochloride (2.0 mg/ml)(2,000ppm) | No breakthrough up to 240 min |
| 6)Etoposide (Toposar)(20.0 mg/ml)(20,000ppm) | No breakthrough up to 240 min |
| 7)Fluorouracil (50.0 mg/ml)(50,000ppm) | No breakthrough up to 240 min |
| 8)Paclitaxel (Taxol)(6.0 mg/ml)(6,000ppm) | No breakthrough up to 240 min |
| 9)Thiotepa (10.0 mg/ml)(10,000ppm) | 24.7 |

The Maximum testing time is 240 minutes. Please note that the following drugs have low permeation time: 1)Carmustine (BCNU)(3.3mg/ml)with Permeation time of 12.9 minutes. 2)Thiotepa ( 10.0mg/ml)with Permeation time of 24.7 minutes.

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

| | Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------|----------------------------------------------|
| <div></div> | Over-The-Counter Use (21 CFR 801 Subpart C) |

_ | 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 for K181066 Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with Tested for use with Chemotherapy Drugs Claims

## 1. Submitter:

| Company Name: | ECO Medi Glove Sdn Bhd. |
|------------------|-----------------------------------------------------------------------------------------------------------|
| Company Address: | Lot 23826, Jalan Tembaga Kuning<br>Kamunting Raya Industrial Estate,<br>34600, Taiping<br>Perak, Malaysia |
| Contact Person: | Mr Suresh Kumar |
| Telephone No: | 603-60283033 |
| Email: | [e-mail] |

## 2. Preparation Date : 12th September 2018

#### 3. Name of the Device

| Trade Name / Proprietary Name: | Powder Free Nitrile Examination Glove (Blue)<br>With Low Dermatitis Potential Claim and with tested<br>for Use with hemotherapy drugs Claims. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name : | Nitrile Patient Examination gloves. |
| Device Classification Name : | Patient Examination gloves (21 CFR 880.6250). |
| Device Class : | Class I. |
| Product Code : | LZA , LZC. |

## 4. Identification of The Legally Marketed Device:

Predicate Device: K152542, Powder Free Nitrile Examination (Blue) with Low Dermatitis Potential Claim with tested for use with Chemotherapy Drugs

## 5. Device Description

The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and nonsterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05 and Modified Draize 95 test.

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## Indication for Use:

The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for medical purpose that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection time in<br>minutes |
|----------------------------------------------------|---------------------------------------------------|
| 1)Carmustine (BCNU) (3.3mg/ml)(3,300 ppm) | 12.9 |
| 2) Cisplatin (1.0mg/ml)(1,000 ppm) | No breakthrough up to 240 min |
| 3)Cyclophosphamide (Cytoxan)(20mg/ml)(20,000 ppm) | No breakthrough up to 240 min |
| 4)Dacarbazine (DTIC)(10.0mg/ml)(10,000 ppm) | No breakthrough up to 240 min |
| 5)Doxorubicin Hydrochloride ( 2.0mg/ml)(2,000 ppm) | No breakthrough up to 240 min |
| 6)Etoposide (Toposar)(20.0mg/ml)(20,000 ppm) | No breakthrough up to 240 min |
| 7)Fluorouracil (50.0mg/ml)(50,000 ppm) | No breakthrough up to 240 min |
| 8)Paclitaxel (Taxol)(6.0mg/ml)(6,000 ppm) | No breakthrough up to 240 min |
| 9)Thiotepa(10.0mg/ml)(10,000 ppm) | 24.7 |

Maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time.

1) Carmustine (BCNU) (3.3mg/ml) with Permeation time of 12.9 minutes.

2) Thiotepa (10mg/ml) with Permeation time of 24.7 minutes

# 6. Specification for Nitrile gloves:

6.1.1 Dimension and Thickness of Gloves

| Dimension | Size S | Size M | Size L | Size XL |
|------------------------------|---------|---------|---------|---------|
| Overall Length (mm) | 230min | 230min | 230min | 230min |
| Width (± 5mm) | 85 | 95 | 105 | 115 |
| Thickness at Palm (mm) | 0.05min | 0.05min | 0.05min | 0.05min |
| Thickness at Finger Tip (mm) | 0.05min | 0.05min | 0.05min | 0.05min |

## 6.1.2 Gloves Physical Properties and Holes

| Measurement | Before Ageing | After Aging at 70°C for<br>168 hrs @ 100°C for 22 hrs |
|-------------------------|---------------------------------|-------------------------------------------------------|
| Tensile Strength (MPa) | 14min | 14 Min |
| Ultimate Elongation (%) | 500min | 400min |
| Pin-hole Level | AQL 2.5<br>Inspection Level G-1 | AQL 2.5<br>Inspection Level G-1 |

Gloves meet all the specification listed in ASTM D 6319-10

6.1.3 Summary of the Technological Characteristics of the Device

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| Characteristics | Acceptance Criteria | Powder Free Nitrile<br>Examination Gloves(Blue) with<br>Low Dermatitis Potential Claim<br>and with tested for use with<br>chemotherapy drugs Claim,<br>K181066 | Powder Free Nitrile<br>Examination Glove (Blue) with<br>Low Dermatitis Potential Claim<br>and with tested for used with<br>Chemotherapy Drugs ,K152542 | Comparison |
|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | LZA, LZC | LZA, LZC | LZA, LZC | Same |
| Intended use | A powder free patient<br>examination glove is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand or<br>finger to prevent<br>contamination between patient<br>and examiner. The device is<br>for over-the-counter use. | A powder free patient<br>examination glove is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand or finger to<br>prevent contamination between<br>patient and examiner. The device<br>is for over-the-counter use. | A powder free patient<br>examination glove is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand or finger to<br>prevent contamination between<br>patient and examiner. The device<br>is for over-the-counter use. | Same |
| Material use | Nitrile<br>compound | Nitrile<br>compound | Nitrile<br>compound | Same |
| Colour | Blue | Blue | Blue | Same |
| Sterility | Non sterile | Non sterile | Non sterile | Same |
| Single used | Single used | Single used | Single used | Same |
| Dimensions | Overall Length (mm)<br>Min 230mm<br>Width (± 5mm)<br>Size S = 85mm<br>Size M = 95mm<br>Size L = 105mm<br>Size XL = 115mm<br>Thickness at Palm (mm)<br>Min; 0.05 mm<br>Thickness at Finger Tip (mm)<br>Min 0.05 mm | Min 230mm | Min 230mm | Same |
| Physical properties | Before Ageing<br>Tensile Strength (MPa)<br>= 14min<br>Ultimate Elongation (%)<br>= 500min<br>After Aging at 70ºC for<br>168 hrs @ 100℃ for 22 hrs<br>Tensile Strength (MPa)<br>= 14min<br>Ultimate Elongation (%)<br>= 400min | Before aging :<br>Tensile strength: Min 14 Mpa<br>Ultimate Elongation : Min 500%<br>After Aging :<br>Tensile strength: Min 14 Mpa<br>Ultimate Elongation : Min 400% | Before aging :<br>Tensile strength: Min 14 Mpa<br>Ultimate Elongation : Min 500%<br>After Aging :<br>Tensile strength: Min 14 Mpa<br>Ultimate Elongation : Min 400% | Same |
| Freedom from<br>pinholes | AQL 2.5<br>Inspection Level G-1 | Meets ASTM D5151-06 | Meets ASTM D5151-06 | Same |
| Residual Powder | ≤ 2.0 mg/pc | ≤ 2.0 mg/pc | ≤ 2.0 mg/pc | Same |
| Biological<br>Evaluation on<br>Medical Device -<br>-Primary Skin<br>Irritation Test | | Under the conditions of this<br>study, the test article was a non-<br>irritant. | Under the conditions of this<br>study, the test article was a non-<br>irritant. | Same |
| Biological<br>Evaluation on<br>Medical Device -<br>Dermal<br>Sensitization<br>Assay | | Under the conditions of this study,<br>the test article was a non-sensitizer. | Under the conditions of this study,<br>the test article was a non-sensitizer. | Same |
| ISO 10993-5:2009 | Biological Evaluation of Medical<br>Device -Part 5: Test for In Vitro<br>Cytotoxicity | Under the conditions of this study,<br>the test article was not cytotoxic. | No test done | Similar |
| Resistance<br>against<br>Chemotherapy<br>Drugs | | 1) Carmustine (3.3mg/ml or<br>3000ppm), Breakthrough : 12.9 min.<br>2) Cyclophosphamide (20mg/ml or<br>20,000ppm), Breakthrough time:<br>>240 min.<br>3) Cisplatin (1mg/ml or 1000ppm),<br>Breakthrough time > 240 min<br>4)Doxorubicin Hydrochloride<br>(2.0mg/ml or 2000ppm),<br>Breakthrough time >240 min.<br>5) Etoposide (20mg/ml or<br>20,000ppm), Breakthrough time:<br>>240 min.<br>6) Flourouracil (50mg/ml or 50,000),<br>Breakthrough time :>240 min.<br>7) Dacarbazine (DTIC) (10mg/ml or<br>10,000ppm), Breakthrough time: ><br>240 min.<br>8) Paclitaxel (6mg/ml or 6,000ppm),<br>Breakthrough time >240 min.<br>9) Thiotepa (10mg/ml or<br>10,000ppm), Breakthrough time:24.7<br>min. | 1) Carmustine (3.3mg/ml or<br>3000ppm), Breakthrough 20.1 min.<br>2) Cyclophosphamide<br>(20mg/ml or 20,000ppm),<br>Breakthrough time: >240 min.<br>3) Cisplatin (1mg/ml or 1000ppm),<br>Breakthrough time: >240 min<br>4)Doxorubicin Hydrochloride<br>(2.0mg/ml or 2000ppm),<br>Breakthrough time: >240 min.<br>5) Etoposide (20mg/ml or<br>20,000ppm), Breakthrough time:<br>>240 min.<br>6) Flourouracil (50mg/ml or 50,000),<br>Breakthrough time : >240 min.<br>7) Methotrexate (25mg/ml or<br>25,000ppm), Breakthrough time: ><br>240 min.<br>8) Paclitaxel (6mg/ml or 6,000ppm),<br>Breakthrough time:>240 min.<br>9) Thiotepa (10mg/ml or<br>10,000ppm), Breakthrough time:<br>50.6 min. | Difference |
| Low Dermatitis<br>Potential Claim | 1)Modified Draize 95 test | No Clinical evidence presence of<br>residual chemical additives that<br>may induce Type IV allergy in<br>human subject | No Clinical evidence presence of<br>residual chemical additives that<br>may induce Type IV allergy in<br>human subject | Same |

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# 7. Summary of Non-Clinical Performance data

Testing was performed per ASTM D6319-10 , ASTM D5151-06, ASTM D6124-06,ISO 10993-10:2010 . ISO10993-5 and 16 CFR Part 1500.41. The glove meets standards requirement referenced in section 6.0 above. Biocompatibility test indicates the gloves are not a contact skin sensitizer, not a primary skin irritant, and not cytotoxic.

## 8. Summary of Clinical Performance Data

Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and tested for Use with Chemotherapy drugs were tested in accordance with Modified Draize -95 test , per FDA's guidance document "Guidance for Industry and FDA Reviewer/Staffs: Premarket Notification [510k] Submissions for testing for skin sensitization to chemical in natural Rubber Products".

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The study was conducted in two stages. In the first, a population of 30 human subjects was tested to evaluate the product for the potential to cause irritation or sensitization. The second stage was initiated on a further number of subjects to a total of a minimum 205 individuals after the first stage has shown that the test product does not indicate a potential for inducing dermal irritation and does not shown sensitization capability

The study completed on 205 non sensitized adult human subjects, who reasonably reflect the general user population in the US, gave all negative results. There was no clinical evidence of the presence of residual chemical additives at the level that may induce type IV allergy in the un-sensitized general user population in the tested articles.

## 9. Conclusion

The conclusions drawn from the nonclinical and clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.