Powder Free Nitrile Examination Glove

K212751 · Dainam Glove Joint Stock Company · LZA · Sep 24, 2022 · General Hospital

Device Facts

• Record ID: K212751
• Device Name: Powder Free Nitrile Examination Glove
• Applicant: Dainam Glove Joint Stock Company
• Product Code: LZA · General Hospital
• Decision Date: Sep 24, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Blue Nitrile Examination Gloves Powder Free are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, powder-free nitrile examination glove; made from acrylonitrile-butadiene copolymer. Worn by healthcare examiners to prevent cross-contamination between patient and examiner. Available in sizes XS through XL. Device is a physical barrier; no electronic or software components. Used in clinical settings. Benefits include protection against contamination during medical examinations.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing including physical properties (tensile strength, elongation), dimensions, watertightness (ASTM D5151), residual powder (ASTM D6124), and biocompatibility (ISO 10993 series: cytotoxicity, sensitization, irritation, systemic toxicity, and material-mediated pyrogenicity).

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer (nitrile). Form factor: Disposable, non-sterile, powder-free glove. Standards: ASTM D6319-2019 (dimensions, physical properties), ASTM D5151-2019 (watertightness), ASTM D6124-06 (residual powder). Biocompatibility: ISO 10993-5, ISO 10993-10, ISO 10993-11. No energy source, software, or connectivity.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-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

• Powder Free Black Nitrile Examination Glove (K201428)

Submission Summary (Full Text)

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September 24, 2022

Dainam Glove Joint Stock Company % Jenny Nguyen Office Manager Bayneto LLC 13480 Veterans Memorial Drive, Suite F Houston, Texas 77014

Re: K212751

Trade/Device Name: Powder Free Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA Dated: August 16, 2022 Received: August 18, 2022

Dear Jenny Nguyen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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

Sincerely,

Bifeng Qian, M.D., Ph.D. 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K212751

Device Name Powder Free Nitrile Examination Glove

Indications for Use (Describe)

Blue Nitrile Examination Gloves Powder Free is disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

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

_ Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary - K212751

| Submitted by: | Dai Nam JSC.<br>1765A Thu Dau Mot<br>Hiep An Ward, Thu Dau Mot, Vietnam. |
|--------------------|--------------------------------------------------------------------------|
| Contact Person: | Damon Nguyen<br>Director of U.S. Market<br>[e-mail] |
| Telephone Number: | 832-458-4388 |
| Date submitted: | September 20, 2022 |
| Trade/Device Name: | Powder Free Nitrile Examination Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Regulation Name: | Non-powdered Patient Examination Glove |
| Regulatory Class: | Class I |
| Product Code: | LZA |

### Identification of the legally marketed device:

| Predicate Device Name: | Powder Free Black Nitrile Examination Glove |
|--------------------------|---------------------------------------------|
| Predicate 510(K) Number: | K201428 |
| Manufacturer's Name: | VIETGLOVE CORPORATION |

### 5.1 Product Description

Dainam JSC., Powder Free Gloves are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile- butadiene copolymer dispersion. These gloves are blue in color and are powder free, non-sterile, single use and disposable and available in size XS-extra small, S-small, M-medium, L-Large, XL- Extra-large.

### 5.2 Intended Use/Indications for Use

Blue Nitrile Examination Gloves Powder Free are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

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| Product | K201428 | K212751 | Results |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | (Predicate) | (Subject) | |
| Design and Size<br>Availability | S,M,L | XS,S,M,L,XL | Similar |
| Materials | Nitrile (Acrylonitrile<br>butadiene) | Nitrile (Acrylonitrile<br>butadiene) | Same |
| Intended<br>use/Indication<br>for Use | Non-Powdered Patient<br>Examination Glove are<br>disposable gloves used<br>during medical<br>examinations and<br>procedures to help<br>prevent cross-<br>contamination between<br>caregivers and patients | Blue Nitrile<br>Examination Gloves<br>Powder Free are<br>disposable devices<br>intended for medical<br>purpose that are worn<br>on the examiner's hand<br>to prevent<br>contamination between<br>patient and examiner. | Similar |
| Color | Black | Blue | ... |
| Product Code | LZA | LZA | Same |
| Classification | Class 1 | Class 1 | Same |
| 510(K) Number | K201428 | K212751 | ... |

# 5.3 Comparison of Technological Characteristics

| Characteristics | Standards | Device Performance | | Comparison |
|---------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| | | Predicate | Subject | |
| 510(K) Number | | K201428 | K212751 | --- |
| Name of device | | Powder Free Black<br>Nitrile Examination<br>Glove | Powder Free Nitrile<br>Examination Glove | --- |
| Dimensions | ASTM D6319-<br>2019 | Length Min 242 m<br>Width Min 95+/-10<br>mm (for medium size) | Length Min 230 mm<br>Width Min 95+/-10<br>mm (for medium size) | Similar |
| Characteristics | Standards | Device Performance | | Comparison |
| | | Predicate | Subject | |
| Physical<br>Properties | ASTM D6319-2019 | Before Aging<br>Tensile Strength min<br>14 Mpa Ultimate<br>Elongation Min<br>500%<br>After Aging Tensile<br>Strength min 14 Mpa<br>Ultimate Elongation<br>Min 508% | Before Aging<br>Tensile Strength min<br>14 Mpa<br>Ultimate Elongation<br>Min 500%<br>After Aging Tensile<br>Strength min 14 Mpa<br>Ultimate Elongation<br>Min 505% | Similar |
| | Thickness | ASTM D6319-2019 | Palm min 0.06 mm Finger<br>min 0.11 mm | Palm min 0.06 mm<br>Finger min 0.09 mm |
| Powder Residue | ASTM D6319-2019 | S: 0.43mg/glove<br>M: 0.31 mg/glove<br>L: 0.47 mg/glove | XS: 0.3mg/glove<br>S: 1.4mg/glove<br>M: 2.0 mg/glove<br>L: 0.5 mg/glove<br>XL: 0.7mg/glove | Similar |
| Biocompatibility | Primary Skin Irritation-<br>ISO 10993-<br>10:2010(E) | Under the condition of<br>study not an irritant | Under the condition<br>of study not an irritant | Same |
| | Dermal Sensitization-<br>ISO 10993-10:2010(E) | Under the conditions of the<br>study not a sensitizer | Under the conditions<br>of the study not a<br>sensitizer | Same |
| | In vitro cytotoxicity<br>ISO10993-5<br>:2009(E) | Under the conditions of the<br>study, cytotoxic | Under the conditions of<br>the study cytotoxic | Same |
| | Acute Systemic Toxicity<br>Test ISO 10993-<br>11:2017(E) | Under the conditions<br>of study the device extracts<br>do not pose a systemic<br>toxicity concern | Under the conditions<br>of study the device<br>extracts do not pose a<br>systemic toxicity<br>concern | Same |
| | Material Mediated<br>Pyrogenicity<br>ISO<br>10993-11:2017(E) / USP<br>41<151> | N/A | Under the conditions of<br>the study the device<br>extract did not show a<br>material mediated<br>pyrogenicity response. | Different |
| Watertight (1000<br>ml) | ASTM D5151-2019 | Passes AQL-2.5 | Passes AQL-2.5 | Similar |
| Material | ASTM D6319-2019 | Nitrile | Nitrile | Same |
| Color | - | Black | Blue | Different |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTM<br>D6319-2019 | Small, Medium, Large | Extra Small, Small,<br>Medium, Large, Extra<br>Large | Similar |
| Sterility | - | Non-sterile | Non-sterile | Same |
| Characteristics Standards | | Device Performance | | Comparison |
| | | Predicate | Subject | |
| Single Use | Medical Glove<br>Guidance Manual | Single Use | Single Use | Same |
| Manufacturer(s) | - | Vietglove<br>Corporation | DaiNam Glove JSC | ------ |

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## 5.4 Summary of Non-Clinical Testing

Non-clinical tests were conducted to verify that the proposed device complies with the following standards:

- 1) ISO 10993-10:2009 MTT Method MEM with 10%FBS extract: In Vitro Cytotoxicity Test of NITRILE EXAM GLOVES.
- 2) ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% sodium Chloride Injection Extract: Sensitization Test of NITRILE EXAM GLOVES.
- 3) ISO 10993-10:2010 0.9% sodium Chloride Injection Extract: Skin Irritation Test of NITRILE EXAM GLOVES.
- 4) ISO 10993-10:2010 Guinea Pig Maximization Test Sesame Oil Extract: Sensitization Test of NITRILE EXAM GLOVES.
- 5) ISO 10993-10:2010 Sesame Oil Extract: Skin Irritation Test of NITRILE EXAM GLOVES.
- 6) ISO 10993-11:2017 Intravenous 0.9% Sodium Chloride Injection Extract: Acute Systemic Toxicity Test of NITRILE EXAM GLOVES.
- 7) ISO 10993-11:2017 Intravenous Sesame Oil Extract: Acute Systemic Toxicity Test of NITRILE EXAM GLOVES
- 8) ISO 10993-11:2017 0.9% Sodium Chloride Injection Extract Rabbit: Pyrogen Test of NITRILE EXAM GLOVES
- 9) ASTM D6319-19, Standard Specification for Gloves for Medical Application.

| Test Method | Purpose | Acceptance Criteria | Result | | | | | | | | | | | | | | | | | | |
|---------------------------------------------------------------------------------|------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| ASTM D6319-2019 Standard<br>Specification for Gloves for Medical<br>Application | To determine the<br>length of the gloves | Min 230 mm for all sizes | X-Small: +/-240 mm<br>Small: +/-240 mm<br>Medium: +/-240 mm<br>Large: +/-240 mm<br>X-Large: +/-240 mm | | | | | | | | | | | | | | | | | | |
| ASTM D6319-2019 Standard<br>Specification for Gloves for<br>Medical Application | To determine the<br>width of the gloves | X-Small: 70+/-10 mm<br>Small: 80+/-10 mm<br>Medium: 95+/-10mm<br>Large: 110+/-10mm X-<br>Large: 120+/-10 mm | X-Small: 70+/-10 mm<br>Small: 80+/-10 mm<br>Medium: 95+/-10mm<br>Large: 110+/-10 mm<br>X-Large: 120+/-10 mm | | | | | | | | | | | | | | | | | | |
| ASTM D6319-2019 Standard<br>Specification for Gloves for Medical<br>Application | To determine the<br>Thickness of the<br>gloves | Palm 0.05 mm min<br>Finger 0.05 mm min for all<br>sizes | Size Palm Finger X-Small 0.07mm 0.10mm Small 0.07mm 0.9mm Medium 0.07mm 0.9mm Large 0.07mm 0.8mm X-Large 0.07mm 0.7mm | | | | | | | | | | | | | | | | | | |

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| Test Method | Purpose | Acceptance Criteria | Size | Result | |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------|
| ASTM D6319-2019 Standard<br>Specification for Gloves for<br>Medical Application | To Determine the<br>physical properties-<br>Tensile strength | Before Ageing Tensile<br>Strength 14Mpa Min for<br>all sizes<br>After Ageing Tensile<br>Strength 14Mpa Min for<br>all sizes | X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before<br>ageing<br>27Mpa<br>26Mpa<br>25Mpa<br>33Mpa<br>32Mpa | After<br>ageing<br>25Mpa<br>26Mpa<br>27Mpa<br>36Mpa<br>33Mpa |
| | To Determine the<br>physical properties-<br>Ultimate Elongation | Before Ageing<br>Ultimate Elongation<br>500% Min for all<br>sizes<br>After Ageing<br>Ultimate<br>Elongation 400%<br>Min for all sizes | X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before<br>ageing<br>520%<br>567%<br>553%<br>568%<br>539% | After<br>ageing<br>509%<br>545%<br>538%<br>560%<br>570% |

| Test Method | Purpose | Acceptance<br>Criteria | Result |
|-----------------------------------------------------------------------------------------------------|------------------------------------------------------|------------------------|--------------------------------------------------------------------------------------------------------------------|
| ASTM D5151-2019 Standard<br>Test Method for Detection of<br>Holes in Medical Gloves | To determine the<br>holes in the gloves | AQL 2.5 | Gloves Passes AQL 2.5 |
| ASTM D6124-06 (Reapproved<br>2017) Standard Test Method<br>for Residual Powder on<br>Medical Gloves | To determine the<br>residual powder in<br>the gloves | 2 Mg/Glove Max | Size<br>X-small 0.3mg/glove<br>Small 1.4mg/glove<br>Medium 2 mg/glove<br>Large 0.5 mg/glove<br>X-Large 0.7mg/glove |

## 5.5 BIOCOMPATIBILITY DATA

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| Test Method | Purpose | Acceptance<br>Criteria | Result |
|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-10 Biological<br>Evaluation of Medical Devices<br>Test for Irritation and Skin<br>Sensitization. Test done for<br>irritation. | To determine the potential of<br>the glove under test to<br>produce dermal irritation in<br>Rabbits | Under the condition<br>of study not an irritant | Under the condition of<br>study not an irritant |
| ISO 10993-10 Biological<br>Evaluation of Medical Devices<br>Test for Irritation and Skin<br>Sensitization. Test done Skin<br>sensitization. | To determine the skin<br>sensitization potential of<br>the glove in Guinea Pig. | Under the conditions<br>of the study not a<br>sensitizer | Under the conditions of<br>the study not a<br>sensitizer |
| ISO 10993-5:2009 biological<br>evaluation of medical devices -<br>part 5, tests for in vitro<br>cytotoxicity. | To evaluate the in vitro<br>cytotoxic potential of the test<br>item in L-929 mouse<br>fibroblasts cells using elution<br>method. | Under the conditions<br>of study non cytotoxic | Under the conditions of<br>the study cytotoxic. |
| ISO 10993-11:2017 biological<br>evaluation of medical devices -<br>part 11, tests for systemic<br>toxicity. | To determine the acute<br>systemic toxicity potential of<br>the test item extracts in mice. | Under the conditions<br>of study, the device<br>extracts do not pose<br>a systemic toxicity<br>concern | Under the conditions<br>of study the device<br>extracts do not pose a<br>systemic toxicity<br>concern |
| Material Mediated Pyrogenicity<br>ISO 10993- 11:2017 | To determine the pyrogenic<br>potential of the test item<br>extract following intravenous<br>injection in Rabbits. | Under the conditions<br>of the study, the<br>device did not<br>demonstrate a<br>material mediated<br>pyrogenicity response. | Under the conditions of<br>the study, the device did<br>not demonstrate a<br>material mediated<br>pyrogenicity response. |

## 5.6 Summary of Clinical Testing

Not applicable - Clinical data is not needed for the subject gloves.

## 5.7 Conclusion

The conclusions drawn from the non-clinical test demonstrate that the subject device is as safe as effective and performs as well as or better than the legally marketed predicated device.