Nitrile Patient Examination Gloves

K211434 · Zhangjiagang Huayuan Protective Equipment Co., Ltd. · LZA · Aug 5, 2021 · General Hospital

Device Facts

• Record ID: K211434
• Device Name: Nitrile Patient Examination Gloves
• Applicant: Zhangjiagang Huayuan Protective Equipment Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 5, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Story

Nitrile patient examination gloves; non-sterile; disposable; ambidextrous; blue color. Manufactured from nitrile; inner surface treated for smooth donning without powder. Available in sizes XS, S, M, L, XL, and XXL. Used in clinical settings by healthcare professionals to provide a barrier against contamination between patient and examiner. Single-use device.

Clinical Evidence

Bench testing only. No clinical data. Compliance verified via ASTM D6319-19 (dimensions/physical properties), ASTM D5151-19 (watertightness/holes), ASTM D6124-06 (powder content), ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation/sensitization).

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, single-use, non-sterile, blue. Dimensions: XS-XXL. Standards: ASTM D6319-19 (physical specs), ASTM D5151-19 (holes), ASTM D6124-06 (powder), ISO 10993-5/10 (biocompatibility).

Indications for Use

Indicated for use as a non-sterile, disposable medical glove worn on the examiner's hands or fingers 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

• Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color (K171422)

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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

August 11, 2021

Zhangjiagang Huayuan Protective Equipment Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161 Lujiazui East Rd., Pudong Shanghai, Shanghai 200120 China

Re: K211434

Trade/Device Name: Nitrile Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA

Dear Boyle Wang:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 5, 2021. Specifically, FDA is updating this SE Letter as an administrative correction for the company's name.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Clarence W. Murray III, Assistant Director of Office of Surgical and Infection Control Devices, at Tel: 301 -796 - 0270 or Email: [e-mail].

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

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Image /page/1/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The logos are simple and professional in appearance.

August 5, 2021

Zhangjiagang Huayan Protective Equipment Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161 Lujiazui East Rd., Pudong Shanghai, Shanghai 200120 China

Re: K211434

Trade/Device Name: Nitrile Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 25, 2021 Received: May 10, 2021

Dear Boyle Wang:

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

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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 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 (DICE(@fda.hhs.gov) 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) K211434

Device Name Nitrile Patient Examination Gloves

Indications for Use (Describe)

The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands 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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## 510(k) Summary (K211434)

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

#### 1.0 Submitter's Information

Zhangjiagang Huayuan Protective Equipment Co., Ltd. Name: Address: No.333,Fumin Middle Road,Tanggiao town,Zhangjiagang City,Jiangsu,China Phone Number: [phone] Contact: Huamei Wang Date of Preparation: Aug.4,2021

#### Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 East Lujiazui Rd.,Pudong,Shanghai 200120 ,China Tel: [phone] Email: [e-mail]

#### 2.0 Device Information

Trade name: Nitrile Patient Examination Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS、S、M、L、XL、XXL

#### 3.0 Classification

Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital

#### 4.0 Predicate Device Information

Manufacturer: Ever Global (Vietnam) Enterprise Corp Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color 510(k) number: K171422

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#### 5.0 Indication for Use

The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.

#### 6.0 Device Description

The subject device is powder free nitrile examination gloves. The glove is manufactured from nitrile. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand. The subject device is blue. The subject device is non-sterile, and single use device to prevent contamination between patient and examiner.

The subject device can be available in six specifications: XS、S、M、L、XL and XXL.

| Table1-General Comparison | | | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Item | Subject Device<br>(K211434) | Predicate Device<br>(K171422) | Remark |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use/<br>Indication for Use | The Nitrile Patient<br>Examination Gloves<br>are non-sterile<br>disposable devices<br>intended for medical<br>purposes that are<br>worn on the<br>examiner's hands or<br>finger to prevent<br>contamination<br>between patient and<br>examiner. | The Nitrile Powder<br>Free patient<br>examination glove<br>is a non-sterile<br>disposable device<br>intended for<br>medical purposes<br>that is worn on the<br>examiner's hands<br>or finger to prevent<br>contamination<br>between patient<br>and examiner. | Same |
| Powdered or<br>Powered free | Powdered or<br>Powered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Labeling Information | Single-use | Single-use | Same |

### 7.0 Technological Characteristic Comparison Table

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| indication, powder | indication, powder |
|---------------------|---------------------|
| free, device color, | free, device color, |
| device name, glove | device name, glove |
| size and quantity, | size and quantity, |
| Nitrile Glove | Disposable Powder |
| Powder Free, Blue, | Free Nitrile |
| Non-Sterile | Examination Glove, |
| | Non-Sterile |

#### Table2 Device Dimensions Comparison

| | Designation | Size | | | | | Tolerance | |
|------------------------------|----------------|-----------|----------|----------|----------|-----------|------------|-----------|
| Predicate<br>Device(K171422) | Length, mm | XS<br>230 | S<br>230 | M<br>230 | L<br>230 | XL<br>230 | min | |
| | Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | |
| | Thickness, mm: | | | | | | | |
| | Finger | 0.05 | | | | | min | |
| | Palm | 0.05 | | | | | min | |
| Subject<br>Device(K211434) | Designation | Size | | | | | | Tolerance |
| | Length, mm | XS<br>220 | S<br>220 | M<br>230 | L<br>230 | XL<br>230 | XXL<br>230 | min |
| | Width, mm | 70 | 80 | 95 | 110 | 120 | 130 | ±10 |
| | Thickness, mm: | | | | | | | |
| | Finger | 0.05 | | | | | | min |
| | Palm | 0.05 | | | | | | min |
| Remark | Similar | | | | | | | |

Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.

#### Table3 Performance Comparison

| Item | Subject device<br>(K211434) | Predicate device<br>(K171422) | Remark | | |
|------------------------|-----------------------------|-------------------------------|------------|------------|------|
| Colorant | Blue | White/ Blue/<br>Black/ Pink | Same | | |
| Physical<br>Properties | Before<br>Aging | Tensile Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate Elongation | 500% min | 500% min | Same |
| | After<br>Aging | Tensile Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate Elongation | 400%min | 400%min | Same |

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| | Comply with ASTM D6319 | | Comply with<br>ASTM<br>D6319 | Same |
|--------------------|------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------|
| Freedom from Holes | | Be free from<br>holes when<br>tested in<br>accordance<br>with<br>ASTMD5151<br>AQL=2.5 | Be free from<br>holes when<br>tested in<br>accordance<br>with<br>ASTMD5151<br>AQL=2.5 | Same |
| Powder Content | | Meet the<br>requirements<br>of ASTM<br>D6124 | Meet the<br>requirements<br>of ASTM<br>D6124 | Same |

### Table4 Safety Comparison

| | | Subject<br>device<br>(K211434) | Predicated<br>device<br>(K171422) | Remark |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------|--------|
| Material | | Nitrile | Nitrile | Same |
| Biocompatibility | Irritation (ISO<br>10993-10:2010<br>Biological<br>Evaluation of<br>Medical Devices -<br>Part 10: Tests For<br>Irritation And Skin<br>Sensitization) | Under the<br>conditions of<br>the study, not<br>an irritant | | |
| | Sensitization<br>(ISO 10993-<br>10:2010<br>Biological<br>Evaluation of<br>Medical Devices -<br>Part 10: Tests For<br>Irritation And Skin<br>Sensitization) | Under<br>conditions of<br>the study, not<br>a sensitizer. | Comply with<br>ISO10993-<br>10 | Same |
| | Cytotoxicity (ISO<br>10993-5:2009<br>Biological<br>Evaluation of<br>Medical Devices -<br>Part 5: Tests For<br>In Vitro) | Under<br>conditions of<br>the study,<br>device<br>extract is not<br>cytotoxic | / | / |

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| (<br>Citotoxicity) |
|--------------------|
|--------------------|

#### 8.0 Summary of Non-clinical Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves

ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

| Test<br>Methodology | Purpose | Acceptance Criteria | Results |
|---------------------|--------------------------------|--------------------------------------------|--------------------------------------|
| ASTM D6319 | Physical<br>Dimensions<br>Test | Length(mm):<br>XS/S:≥220;<br>M/L/XL: ≥230. | Length: >230 |
| | | Width(mm): | Width: |
| | | XS: 70±10; | XS: 78-80 |
| | | S: 80±10; | S: 86-89 |
| | | M: 95±10; | M: 97-99 |
| | | L: 110±10; | L: 117-119 |
| | | XL: 120±10; | XL: 116-118 |
| | | XXL: 130±10 | XXL:128-131 |
| | | | Pass |
| | | Thickness (mm): | XS: |
| | | Finger: ≥0.05<br>Palm: ≥0.05 | Finger: 0.08-0.10<br>Palm: 0.07-0.09 |
| | | | S: |
| | | | Finger: 0.07-0.11<br>Palm: 0.07-0.09 |
| | | | M: |
| | | | Finger: 0.08-0.13<br>Palm: 0.08-0.10 |

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| | | | | | L: |
|------------|-----------------------------------------------------|---------------------------------------------|------------------------|---------------------|---------------------------------------------------------------------------------------------------------|
| | | | | | Finger: 0.09-0.13 |
| | | | | | Palm: 0.08-0.11 |
| | | | | | XL: |
| | | | | | Finger: 0.08-0.11 |
| | | | | | Palm: 0.07-0.11 |
| | | | | | XXL: |
| | | | | | Finger: 0.08-0.10 |
| | | | | | Palm: 0.07-0.11 |
| | | | | | Pass |
| ASTM D5151 | Watertightness<br>Test for<br>Detection of<br>Holes | Meet the requirements of ASTM D5151 AQL 2.5 | | | 2/125,0/125,<br>0/125,1/125,<br>0/125,0/125 leaks<br>Pass |
| ASTM D6124 | Powder<br>Content | Meet the requirements of ASTM D6124 < 2.0mg | | | 0.05,0.06,0.08,<br>0.07,0.09,0.06<br>Pass |
| ASTM D412 | Physical<br>properties | Before<br>Aging | Tensile<br>Strength | ≥14MPa | XS:15.4-17.3<br>S: 15.3-16.9<br>M: 15.2-17.1<br>L: 15.4-17.6<br>XL: 15.3-17.1<br>XXL: 15.3-17.4<br>Pass |
| | | | Ultimate<br>Elongation | ≥500% | XS:524-569<br>S: 525-568<br>M: 521-570<br>L: 527-567<br>XL: 520-570<br>XXL: 529-579<br>Pass |
| | | | After<br>Aging | Tensile<br>Strength | ≥14MPa |

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| | | Elongation | S: 522-570<br>M: 520-569<br>L: 521-567<br>XL: 528-563<br>XXL: 519-580<br>Pass |
|--------------|---------------|-----------------|----------------------------------------------------------------------------------------------------|
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of<br>the study, did not<br>show potential<br>toxicity to L-929<br>cells.<br>Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the<br>conditions of the<br>study, not an<br>irritant.<br>Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of<br>the study, not a<br>sensitizer.<br>Pass |

#### 9.0 _Summary of Clinical Testing

Clinical testing is not needed for this device.

#### 10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, Nitrile Patient Examination Gloves,are as safe, as effective, and perform as well as or better than the legally marketed predicated device in K171422.