Disposable Nitrile Examination Gloves

K203805 · Jiangsu Yanfang Medical Technology Co., Ltd. · LZA · Apr 20, 2021 · General Hospital

Device Facts

• Record ID: K203805
• Device Name: Disposable Nitrile Examination Gloves
• Applicant: Jiangsu Yanfang Medical Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Apr 20, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Disposable Nitrile Examination Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination gloves; non-sterile; powder-free; ambidextrous design. Worn by healthcare examiners to provide a protective barrier; prevents cross-contamination between patient and examiner. Subject device available in blue; various sizes (S, M, L, XL). Manufactured from nitrile material. Used in clinical or medical environments. Performance verified through bench testing for physical properties (tensile strength, elongation), freedom from holes, and biocompatibility (irritation, sensitization, cytotoxicity).

Clinical Evidence

No clinical data. Bench testing only. Compliance verified with ASTM D6319-19 (physical properties), ASTM D5151-19 (freedom from holes), ASTM D6124-06 (residual powder), ISO 10993-10:2010 (irritation and sensitization), and ISO 10993-5:2009 (cytotoxicity).

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, powder-free, non-sterile gloves. Standards: ASTM D6319-19 (specifications), ASTM D5151-19 (holes), ASTM D6124-06 (powder), ISO 10993-5/10 (biocompatibility).

Indications for Use

Indicated for use as a protective barrier worn on the examiner's hands to prevent contamination between patient and examiner in medical settings.

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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.

April 20, 2021

Jiangsu Yanfang Medical Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K203805

Trade/Device Name: Disposable Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: December 23, 2020 Received: December 28, 2020

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 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,

Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K203805

Device Name Disposable Nitrile Examination Gloves

Indications for Use (Describe)

The Disposable Nitrile Examination Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|----------------------------------------------------------|--|
|----------------------------------------------------------|--|

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 (K203805)

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

### 1.0 Submitter's Information

Name: Jiangsu Yanfang Medical Technology Co., Ltd. Address: No.16, Kaiyuan Road, Changjing Town, Jiangyin, Wuxi, Jiangsu, China 214411 Phone Number: [phone] Contact: Wei Kaijian Date of Preparation: Apr.20,2021

#### Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: [phone] Email: [e-mail]

# 2.0 Device Information

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

# 3.0 Classification

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

# 4.0 Predicate Device Information

Ever Global (Vietnam) Enterprise Corp Manufacturer: Disposable Powder Free Nitrile Examination Glove, White/ Device:

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# Blue/ Black/ Pink Color 510(k) number: K171422

# 5.0 Indication for Use

The Disposable Nitrile Examination Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

# 6.0 Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

# 7.0 Technological Characteristic Comparison Table

| Item | Subject Device<br>(K203805) | Predicated Device<br>(K171422) | Remark |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable<br>Nitrile Examination<br>Gloves is intended<br>for medical<br>purposes that is<br>worn on the<br>examiner's hands<br>to prevent<br>contamination<br>between patient<br>and examiner. | The Disposable<br>Powder Free Nitrile<br>Examination Glove,<br>White/ Blue/ Black/<br>Pink Color is a<br>disposable device<br>intended for<br>medical purposes<br>that is worn on the<br>examiner's hands<br>to prevent<br>contamination<br>between patient<br>and examiner. | Same |
| Powdered or<br>Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non sterile | Non sterile | Same |
| Labeling Information | Single-use<br>indication, powder<br>free, device color,<br>device name | Single-use<br>indication, powder<br>free, device color,<br>device name, glove | Same |

#### Table1-General Comparison

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| | glove size and<br>quantity, Nitrile<br>Glove Powder<br>Free Blue, Non-<br>Sterile | size and quantity,<br>Disposable Powder<br>Free Nitrile<br>Examination Glove,<br>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 | $\pm 5$ |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | min | |
| | Palm | 0.05 | | | | min | |
| Subject Device<br>(K203805) | Designation<br>Length, mm | S<br>220 | M<br>230 | L<br>230 | XL<br>230 | | min |
| | Width, mm | 80 | 95 | 110 | 120 | | $\pm 10$ |
| | 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>(K203805) | Predicated device<br>(K171422) | Remark | | |
|------------------------|-----------------------------|--------------------------------|------------------------------|------------|------|
| Colorant | Blue | White/ Blue/<br>Black/ Pink | Similar | | |
| Physical<br>Properties | Before<br>Aging | Tensile<br>Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate<br>Elongation | 500% min | 500% min | Same |
| | After<br>Aging | Tensile<br>Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate<br>Elongation | 400%min | 400%min | Same |
| Physical<br>Properties | Comply with ASTM D6319 | | Comply with<br>ASTM<br>D6319 | Same | |

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

Analysis: The subject device is only available in a single color (blue,) however, the predicate is available in multiple colors (white, blue, black, pink). Biocompatibility testing was successfully completed for the subject device, demonstrating that any color differences do not affect the safety of the proposed device.

| Table4 Safety Comparison | | | | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------|-----------|
| Item | | Subject device<br>(K203805) | Predicated device<br>(K171422) | Remark |
| Material | | Nitrile | Nitrile | Same |
| Biocompatibility | Irritation (ISO 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.<br>Complies with<br>ISO-10993-10. | | Same |
| | 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 a<br>sensitizer.<br>Complies with<br>ISO-10993-10. | Comply with<br>ISO10993-10 | |
| | Cytotoxicity (ISO<br>10993-5:2009<br>Biological<br>Evaluation of<br>Medical Devices -<br>Part 5: Tests For<br>In Vitro | Under the<br>conditions of<br>the study, not<br>cytotoxic.<br>Complies with<br>ISO-10993-5. | / | Different |

#### Table4 Safety Comparison

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| Cytotoxicity) | | |
|---------------|---|--|
| | - | |

Analysis: Cytotoxicity information for the predicate device is not publicly available. This does not raise different safety or performance questions since the subject device has acceptable biocompatibility per the biocompatibility endpoint assessment.

# 8.0 Discussion of Non-clinical and Performance 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.

# 9.0 Discussion of Clinical and Performance Testing

Clinical testing is not needed for this device.

#### 10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device in K203805, Disposable Nitrile Examination Gloves ,is as safe, as effective, and performs as well as or better than the legally marketed predicated device cleared under K171422.