Nitrile Gloves (Model: NE01)

K212840 · Byd Auto Industry Company Limited · LZA · Dec 11, 2021 · General Hospital

Device Facts

• Record ID: K212840
• Device Name: Nitrile Gloves (Model: NE01)
• Applicant: Byd Auto Industry Company Limited
• Product Code: LZA · General Hospital
• Decision Date: Dec 11, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Nitrile examination gloves (Model: NE01); powder-free; non-sterile; disposable. Manufactured from nitrile compound; blue colorant (Phthalocyanine blue/Propylene glycol). Features smooth surface, textured fingertips, rolled cuff. Available in S, M, L, XL sizes. Used in clinical settings by healthcare providers to provide a barrier against contamination between patient and examiner. Device functions as a physical barrier; no electronic or software components. Benefits include protection against cross-contamination during medical examinations.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D6319-19 for physical dimensions, tensile strength, ultimate elongation (before/after aging), freedom from holes (ASTM D5151), and residual powder (ASTM D6124). Biocompatibility verified via ISO 10993-10 (skin irritation/sensitization) and ISO 10993-11 (acute systemic toxicity).

Technological Characteristics

Nitrile compound; powder-free; non-sterile. Textured fingertips; rolled cuff. Dimensions and physical properties conform to ASTM D6319-19. Biocompatibility per ISO 10993-10 and 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 or fingers to prevent contamination between patient and examiner. Suitable for general patient examination use.

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

• LYDUS Nitrile Examination Gloves, Powder Free (K203191)

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 11, 2021

BYD Auto Industry Company Limited % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong China

Re: K212840

Trade/Device Name: Nitrile Gloves (Model: NE01) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 30, 2021 Received: September 7, 2021

Dear Cassie Lee:

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,

Clarence W. Murray, III, PhD 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) K212840

Device Name Nitrile Gloves (Model: NE01)

Indications for Use (Describe)

A disposable device intended for medical purposes that is worn on the examiner's hand or fingers 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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# 510(k) Summary

This summary of 510(K) is being submitted in accordance with the requirement of 21 CFR 807.92.

#### 1. Date of the summary prepared: August 30, 2021

### 2. Submitter's Information

Sponsor Name: BYD Auto Industry Company Limited Address: No.3001, 3007, Hengping Road, Pingshan, Shenzhen, Guangdong Establishment Registration Number: Applying Post Code: 518119 Contact name: Jianling Liu Tel: [phone]-67228 Tel: [phone] E-mail: [e-mail]

#### Manufacture Factory:

Company: Hengchang(Dongying) Medical Technology Co.,Ltd. Address: No.26 Xinghe Road, Niuzhuang Town, Dongying Distict, Dongying City Contact name: Jianling Liu Tel: [phone] E-mail: [e-mail]

## Application Correspondent:

Contact Person: Ms. Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: [phone] Email: [e-mail]

## 3. Subject Device Information

Type of 510(k): Traditional Common Name: Polymer Patient Examination Glove

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| Sponsor: | BYD Auto Industry Company Limited |
|-----------------|-----------------------------------|
| Subject Device: | Nitrile Gloves (Model: NE01) |
| Document Name: | 510(k) Summary – K212840 |

Classification Name: Non-powdered patient examination glove Trade Name: Nitrile Gloves Model Name: NE01 Review Panel: General Hospital Product Code: LZA Regulation Number: 21 CFR 880.6250 Requlatory Class: Class I

### 4. Predicate Device Information

Sponsor: Nathan Trading Co., Ltd. Common Name: Polymer Patient Examination Glove Classification Name: Non-powdered patient examination glove Trade Name: LYDUS Nitrile Examination Gloves, Powder Free 510(k) Number: K203191 Review Panel: General Hospital Product Code: LZA Regulation Number: 21 CFR 880.6250 Regulatory Class: Class I

## 5. Device Description

The proposed devices are powder-free nitrile examination gloves, provided as non-sterile and disposable devices. The proposed devices are mainly made from nitrile and there are four sizes, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is NBR BLUE 7214 (which composed of Phthalocyanine blue (CAS No.147-14-8) and Propylene glycol (CAS No.57-55-6). The examination glove is smooth surface with textured fingertips and a rolled rim atthe cuff edge.

The examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

#### 6. Intended Use / Indications for Use

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

#### 7. Technological Characteristic Comparison to predicate device and conclusion

| Elements of Comparison | Subject Device | Predicate Device | Result |
|------------------------|----------------|------------------|--------|
|------------------------|----------------|------------------|--------|

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| Sponsor: | BYD Auto Industry Company Limited |
|-----------------|-----------------------------------|
| Subject Device: | Nitrile Gloves (Model: NE01) |
| Document Name: | 510(k) Summary – K212840 |

| Elements of Comparison | Subject Device | Predicate Device | Result |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Company | BYD Auto Industry<br>Company Limited | Nathan Trading Co., Ltd. | -- |
| 510 (k) Number | K212840 | K203191 | -- |
| Trade Name | Nitrile Gloves | Nitrile Examination Gloves,<br>Powder Free | -- |
| Product Code | LZA | LZA | Same |
| Classification Name | Non-powdered patient<br>examination glove | Non-powdered patient<br>examination glove | Same |
| Classification | Class I | Class I | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications For Use | A disposable device<br>intended for medical<br>purposes that is worn on<br>the examiner's hand or<br>fingers to prevent<br>contamination between<br>patient and examiner. | LYDUS Nitrile Examination<br>Gloves, Powder Free is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand or<br>fingers to prevent contamination<br>between patient and examiner. | Same |
| Material of Use | Nitrile compound | Nitrile compound | Same |
| Color | Blue | Blue | Same |
| Texture | Finger Textured | Finger Textured | Same |
| Size<br>(ASTM D6319-19) | Small, Medium, Large,<br>Extra Large | Small, Medium, Large, Extra<br>Large | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Usage | Single usage | Single usage | Same |
| Dimensions<br>(ASTM D6319-19) | Length:<br>For S: $\geq$ 220mm<br>For M/L/XL: $\geq$ 230mm<br>Width:<br>For S: 80 $\pm$ 10mm<br>For M: 95 $\pm$ 10 mm<br>For L: 110 $\pm$ 10 mm<br>For XL: 120 $\pm$ 10 mm | Length Min: 230 min<br>(for medium size)<br>Width Min: 95 $\pm$ 10 mm<br>(for medium size) | Same<br>Note 1 |
| Physical Properties | Before Aging: | Before Aging: | Same |

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| Sponsor: | BYD Auto Industry Company Limited |
|-----------------|-----------------------------------|
| Subject Device: | Nitrile Gloves (Model: NE01) |
| Document Name: | 510(k) Summary – K212840 |

| Elements of Comparison | Subject Device | Predicate Device | Result |
|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| (ASTM D6319-19) | Tensile Strength: ≥14Mpa<br>Ultimate Elongation:<br>≥500%<br><br>After Aging:<br>Tensile Strength: ≥14Mpa<br>Ultimate Elongation:<br>≥400% | Tensile Strength: Min 14 Mpa<br>Ultimate Elongation: Min 500%<br><br>After Aging:<br>Tensile Strength: Min 14Mpa<br>Ultimate Elongation: Min 400% | |
| Thickness<br>(ASTM D6319-19) | Palm: ≥0.05mm<br>Finger: ≥0.05mm | Palm min. 0.05 mm<br>Finger min. 0.05 mm | Same |
| Powder Free<br>(ASTM D6319-19) | ≤2 mg/glove | ≤2 mg/glove | Same |
| Freedom from Holes (Water<br>Tight -1000 ml)-ASTM D6319-<br>19 (Cross Reference D5151) | Passed | Passed | Same |
| Biocompatibility - Skin<br>Sensitization (ISO 10993-<br>10:2010) | Under the conditions of the<br>study not a sensitization | Under the conditions of the<br>study not a sensitizer | Same |
| Biocompatibility - Skin Irritation<br>(ISO 10993-10:2010) | Under the conditions of<br>study not an irritation | Under the conditions of study<br>not an irritant | Same |
| Biocompatibility - Acute<br>Systemic Toxicity (ISO 10993-<br>11: 2017) | Under the conditions of the<br>study no systemic toxicity | No systemic toxicity under the<br>experimental conditions<br>employed | Same |

## Comparison in Detail(s):

# Note 1:

Although the "Dimensions" of subject device is a little difference with predicate devices, but they all met the requirements of the standard ASTM D6319-19..

#### 8. Test Summary

## 8.1 Summary of Non-Clinical Performance Testing

#### Performance Testing Summary: 1)

| Test Method | Test Purpose | Acceptance | Test Results | Conclusion |
|-------------|--------------|------------|--------------|------------|
|-------------|--------------|------------|--------------|------------|

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| Sponsor: | BYD Auto Industry Company Limited |
|-----------------|-----------------------------------|
| Subject Device: | Nitrile Gloves (Model: NE01) |
| Document Name: | 510(k) Summary – K212840 |

| | | Criteria | | ion |
|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| ASMT D6319-19 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application -<br>Physical Dimensions Test | To determine the<br>width, length, and<br>thickness of the<br>gloves | Width: | | Passed |
| | | For M: 95 $\pm$ 10mm | For M: 93~96mm | |
| | | For L: 110 $\pm$ 10mm | For L: 104-107mm | |
| | | For XL: 120 $\pm$ 10mm | For XL:<br>112~116mm | |
| | | Length: | | |
| | | For M: ≥230mm | For M: 236~239mm | |
| | | For L: ≥230mm | For L: 236~239mm | |
| | | For XL: ≥230mm | For XL:<br>255~258mm | |
| | | Thickness: | For M: | |
| | | Finger: ≥0.05mm<br>Palm: ≥0.05mm | Finger:<br>0.06~0.09mm<br>Palm: 0.06~0.08mm | |
| | | | For L:<br>Finger:<br>0.06~0.08mm<br>Palm: 0.06~0.08mm | |
| | | | For XL:<br>Finger:<br>0.08~0.10mm<br>Palm: 0.06~0.09mm | |
| ASMT D6319-19 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application -<br>Physical Dimensions Test | To determine the<br>tensile strength<br>and ultimate<br>elongation before<br>and after<br>acceleration<br>aging | Before Aging:<br>Tensile Strength:<br>≥14Mpa<br>Ultimate<br>Elongation: ≥500%<br>After Aging:<br>Tensile Strength:<br>≥14Mpa<br>Ultimate | Before Aging:<br>Tensile Strength:<br>≥14Mpa<br>Ultimate Elongation:<br>≥500%<br>After Aging:<br>Tensile Strength:<br>≥14Mpa<br>Ultimate Elongation: | Passed |

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| Sponsor: | BYD Auto Industry Company Limited |
|-----------------|-----------------------------------|
| Subject Device: | Nitrile Gloves (Model: NE01) |
| Document Name: | 510(k) Summary – K212840 |

| | | Elongation: ≥400% | ≥400% | |
|------------------------------------------------------------------------------------------------------|------------------------------------------------------|-------------------|--------------------------------------------------------------------------------------------------------|--------|
| ASTM D6319-19 (ASTM<br>D5151-11) Standard Test<br>Method for Detection of<br>Holes in Medical Gloves | To determine the<br>holes in the<br>gloves | AQL 2.5 | Pass at AQL 2.5 | Passed |
| ASMT D6319-19 (ASTM<br>D6124-11) Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves | To determine the<br>residual powder<br>in the gloves | < 2.0 mg/glove | For M: Pass at 0.46<br>mg/glove<br>For L: Pass at 0.52<br>mg/glove<br>For XL: Pass at<br>0.14 mg/glove | Passed |

# 2) Biocompatibility Testing Summary:

| Test Method | Test Purpose | Acceptance<br>Criteria | Test Results | Conclusion |
|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|------------|
| ISO 10993-10<br>Biological evaluation<br>of medical devices -<br>Part 10: Tests for skin<br>irritation and skin<br>sensitization | To evaluate the<br>potential<br>intracutaneous<br>reactivity caused by<br>intracutaneously inject<br>the extract to rabbits | Under the<br>conditions of study<br>not an irritation | Under the<br>conditions of the<br>study not a<br>sensitization | Passed |
| ISO 10993-10<br>Biological evaluation<br>of medical devices -<br>Part 10: Tests for skin<br>irritation and skin<br>sensitization | To determine the skin<br>sensitization potential<br>in guinea pigs. | Under the<br>conditions of the<br>study not a<br>sensitization | Under the<br>conditions of<br>study not an<br>irritation | Passed |
| ISO 10993-11:2017<br>Biological evaluation<br>of medical devices -<br>Part 11: Tests for<br>acute systemic toxicity | The test item was<br>evaluated for acute<br>systemic toxicity in<br>ICR mouse | Under the<br>conditions of the<br>study no systemic<br>toxicity | Under the<br>conditions of the<br>study no<br>systemic toxicity | Passed |

# 8.2 Summary of Clinical Performance Test

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No clinical study is included in this submission.

### 9. Final Conclusion:

The conclusions drawn from the nonclinical test demonstrate that the subject device is a safe, as effective, and perform as well or better than the legally marketed predicated K203191.