Nitrile Examination Gloves Powder Free (Blue)

K210868 · Great Eco Glove Sdn. Bhd. · LZA · Sep 2, 2021 · General Hospital

Device Facts

• Record ID: K210868
• Device Name: Nitrile Examination Gloves Powder Free (Blue)
• Applicant: Great Eco Glove Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Sep 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Nitrile Examination Gloves Powder Free (Blue) 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.

Device Story

Disposable, non-sterile, ambidextrous nitrile examination gloves; worn by clinicians on hands/fingers to provide barrier protection against contamination between patient and examiner. Device manufactured from synthetic nitrile rubber; features beaded cuff. Used in clinical settings; no specialized operator required. Output is physical barrier; aids in infection control protocols. Benefits patient and clinician by reducing cross-contamination risk.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including physical properties (tensile strength, elongation), dimensions, freedom from holes (ASTM D5151-19), residual powder content (ASTM D6124-06), and biocompatibility (ISO 10993-10:2010).

Technological Characteristics

Synthetic nitrile rubber; non-sterile; ambidextrous; beaded cuff. Complies with ASTM D6319-10 (2015) for dimensions, physical properties, and powder content. Biocompatibility per ISO 10993-10:2010. No software or electronic components.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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

• Orange Non Sterile Powder Free Nitrile Examination Gloves (K172642)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and 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 2, 2021

Great Eco Glove Sdn. Bhd. Soh Li QA/OC Manager Lot 1675, Jalan Makmur, Batu 28, Ijok Bestari Jaya, Selangor 45600 Malaysia

Re: K210868

Trade/Device Name: Nitrile Examination Gloves Powder Free (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 6, 2021 Received: August 6, 2021

Dear Soh 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/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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Liqun Zhao -S

For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K210868

Device Name

Nitrile Examination Gloves Powder Free (Blue)

Indications for Use (Describe)

Disposable device intended for medical purpose that is worn on the examiner's hand or finger 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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Image /page/3/Picture/0 description: The image shows the logo for GREAT ECO GLOVE SDN BHD (970327-V). The logo consists of a stylized globe on the left, with the company name in red and green text to the right of the globe. The company registration number is in parentheses after the company name.

#### 1.0 510(k) Summary – K210868

| 1.1 Submitter: | |
|----------------------------|-----------------------------------------------------------|
| Name: | Great Eco Glove Sdn. Bhd. |
| Address: | Lot 1675, Jalan Makmur, Batu 28, Ijok, |
| | 45600, Bestari Jaya, Selangor, Malaysia. |
| Contact: | [phone] / [phone] |
| 1.2 Contact Person: | |
| Name: | Dr. Neoh Vee Heng (Executive Chairman) |
| Email: | [e-mail] |
| Name: | Mr. Ian Neoh Puay Guan (Assistant General Manager) |
| Email: | [e-mail] |
| Name: | Ms. Shahnaz Sakinah Binti Shaiful Bahri (QA/QC Executive) |
| Email: | [e-mail] |
| Date of summary prepared: | 23rd December 2020 |
| 1.3 Name of Device: | |
| Trade Name: | Nitrile Examination Gloves Powder Free (Blue) |
| Common Name: | Patient Examination Glove |
| Classification Name: | Patient Examination Glove |
| Classification Regulation: | 21 CFR 880.6250 |

Device Class: l Product Code: LZA Classification Panel: General Hospital

#### Legally Marketed Predicate Device: 1.4

| | Predicate Device |
|------------------------------|--------------------------------------------------------------|
| Manufacturer | Central Medicare Sdn. Bhd. |
| Trade Name | Orange Non Sterile Powder Free<br>Nitrile Examination Gloves |
| 510 (k) Number | K172642 |
| Product Code | LZA |
| Classification<br>Regulation | 21 CFR 880.6250 |
| Device Class | I |

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Image /page/4/Picture/0 description: The image shows the logo for GREAT ECO GLOVE SDN BHD. The logo features a stylized globe on the left, with the company name in red and green text to the right of the globe. The registration number (970327-V) is in smaller text to the right of the company name.

#### Device Description: 1.5

Nitrile Examination Gloves Powder Free (Blue) are available in blue color. The proposed device is single use, non-sterile, ambidextrous and meets all the requirements of ASTM Specification D6319-10 (2015) — Standard Specification for Nitrile Examination Gloves for Medical Application.

### 1.6 Intended Use:

Nitrile Examination Gloves Powder Free (Blue) 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.

#### Technological Characteristics: 1.7

Nitrile Examination Gloves Powder Free (Blue) have either similar or the same technological characteristics as compared to the legally marketed predicated device, K172642, Orange Non Sterile Powder Free Nitrile Examination Gloves:

| Characteristics | Standards | Proposed Device:<br>K210868 | Predicate Device:<br>K172642 | Comparison |
|------------------------------|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | General | | |
| Manufacturer | N/A | Great Eco Glove Sdn.<br>Bhd. | Central Medicare Sdn.<br>Bhd. | N/A |
| Trade Name | N/A | Nitrile Examination<br>Gloves Powder Free<br>(Blue) | Orange Non Sterile<br>Powder Free Nitrile<br>Examination Gloves | Different |
| Product Code | N/A | LZA | LZA | Same |
| Classification<br>Regulation | N/A | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Device Class | N/A | I | I | Same |
| Indication<br>for<br>use | N/A | Nitrile Examination<br>Gloves Powder Free<br>(Blue) is a disposable<br>device intended for<br>medical purpose that<br>is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between examiner<br>and patient. | Orange Non Sterile<br>Powder Free Nitrile<br>Examination Gloves is<br>a disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's<br>hands to prevent<br>contamination<br>between patient and<br>examiner. | Same |
| Material<br>Composition | ASTM D6319-10<br>(2015) | Synthetic nitrile<br>rubber | Synthetic nitrile<br>rubber | Similar |
| Color | N/A | Blue | Orange | Different |
| Design | N/A | Non-sterile<br>Single use<br>Powder free | Non-sterile<br>Single use<br>Powder free | Same |
| | | Ambidextrous | Ambidextrous | |
| | | Beaded cuff | Beaded cuff | |
| Labeling | N/A | Meet FDA's<br>recommendations | Meet FDA's<br>recommendations | Similar |
| | | Performance | | |
| | | Length ≥ 230 mm | Length ≥ 230 mm | Similar |
| | | Palm Width: | Palm Width: | Similar |
| | ASTM D6319-10<br>(2015) | Size S - 85 ± 5 mm | Size S - 80 ± 10 mm | |
| | | Size M - 95 ± 5 mm | Size M - 95 ± 10 mm | |
| Dimension | | Size L - 105 ± 5 mm<br>Size XL - 115 ± 5 mm | Size L - 110 ± 10 mm<br>Size XL - 120 ± 10 mm | |
| | | Thickness:<br>Finger ≥ 0.05 mm<br>Palm ≥ 0.05 mm | Thickness:<br>Finger ≥ 0.05 mm<br>Palm ≥ 0.05 mm | Similar |
| | | Tensile Strength:<br>Before aging ≥ 15<br>MPa<br>After aging ≥ 14 MPa | Tensile Strength:<br>Before aging ≥ 15<br>MPa<br>After aging ≥ 14 MPa | Similar |
| | ASTM D6319-10<br>(2015) | Ultimate Elongation:<br>Before aging ≥ 500 %<br>After aging ≥ 400 % | Ultimate Elongation:<br>Before aging ≥ 500 %<br>After aging ≥ 400 % | Similar |
| Physical<br>Properties | | | | |
| | | | | |
| | ASTM D6319-10<br>(2015)<br>ASTM D5151-19 | Passes or exceeds<br>ASTM D6319-10<br>(2015) and ASTM<br>D5151-19<br>requirements of AQL<br>2.5 / Inspection level<br>G1 | Passes or exceeds<br>ASTM D6319-10<br>(2015) and ASTM<br>D5151-19<br>requirements of AQL<br>2.5 / Inspection level<br>G1 | Similar |
| Freedom of<br>Holes | | | | |
| | | | | |
| Powder<br>Content | ASTM D6319-10<br>(2015)<br>ASTM D6124-06<br>(2011) | ≤ 2 mg/glove | ≤ 2 mg/glove | Similar |
| Biocompatibility | ISO 10993-<br>10:2010 | Primary Skin Irritation:<br>Under conditions of<br>the study not an<br>irritant | Primary Skin<br>Irritation: Under<br>conditions of the<br>study not an irritant | Similar |
| | | | | |
| | | Dermal Sensitization:<br>Under conditions of<br>the study not a<br>sensitizer | Dermal Sensitization:<br>Under conditions of<br>the study not a<br>sensitizer | |

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GREAT ECO GLOVE SDN BHD (970327-V)

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Image /page/6/Picture/0 description: The image shows the logo for GREAT ECO GLOVE SDN BHD. The logo features a green and blue globe graphic on the left. To the right of the graphic is the company name in red and green text, with the registration number (970327-V) in parentheses.

#### Summary of Non-Clinical Performance Data: 1.8

Test results below demonstrated that the proposed device complies with the following specification and guidance:

- ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. -
- -Guidance for Industry and FDA Staff Medical Glove Guidance Manual (Document issued on January 22, 2008)

The following standards were followed to carry out the testing:

- -ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- -ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves.
- ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
- -ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers -Tension -
- ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves -
- -ASTM D573 - 04 Standard Test Method for Rubber—Deterioration in an Air Oven

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GREAT ECO GLOVE SDN BHD (970327-V)

## Non-clinical Testing Summary

| Test Method | Purpose | Acceptance Criteria | Result |
|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------|
| ASTM D6319-10<br>(Reapproved 2015)<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application | To determine<br>the length of the<br>gloves | Length ≥ 230 mm for all<br>sizes | Pass |
| ASTM D6319-10<br>(Reapproved 2015)<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application | To determine<br>the width of the<br>gloves | Size S – 85 ± 5 mm<br>Size M – 95 ± 5 mm<br>Size L – 105 ± 5 mm<br>Size XL – 115 ± 5 mm | Pass |
| ASTM D6319-10<br>(Reapproved 2015)<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application | To determine<br>the thickness of<br>the gloves | Finger ≥ 0.05 mm<br>Palm ≥ 0.05 mm for all<br>sizes | Pass |
| ASTM D5151-19<br>Standard Test Method<br>for Detection of Holes in<br>Medical Gloves. | To determine<br>the holes in the<br>gloves | Accept: 5 out of 125<br>pieces sample size | Pass |
| ASTM D6124-06<br>(Reapproved 2017),<br>Standard Test Method<br>for Residual Powder on<br>Medical Gloves. | To determine<br>the residual<br>powder in the<br>gloves | ≤ 2 mg/glove | Pass (0.70 mg/glove) |

| ASTM<br>D6319-10<br>(Reapproved 2015)<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application | To determine<br>the physical<br>properties -<br>Tensile strength | Tensile Strength:<br>Before aging ≥ 14 MPa<br>After aging ≥ 14 MPa | Before aging,<br>Average: 24.83 MPa<br>Median: 24.90 MPa<br><br>After aging,<br>Average: 26.23 MPa<br>Median: 25.95 MPa |
|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| | To determine<br>the physical<br>properties –<br>Ultimate<br>Elongation | Ultimate Elongation:<br>Before aging ≥ 500 %<br>After aging ≥ 400 % | Before aging,<br>Average: 509.23 %<br>Median: 500 %<br><br>After aging,<br>Average: 436.92 %<br>Median: 440 % |

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Image /page/8/Picture/0 description: The image shows the logo for Great Eco Glove SDN BHD. The logo features a stylized globe graphic on the left. The text "GREAT ECO GLOVE SDN BHD" is in red and green, followed by the registration number "(970327-V)" in black.

## 1.9 Summary of Clinical Performance Data:

Clinical data is not necessary for Class I Patient Examination Glove 510(k) Submissions.

### 1.10 Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicated device, K172642, Orange Non Sterile Powder Free Nitrile Examination Gloves.