Nitrile Patient Examination Gloves, Powder Free, Pink Color

K222103 · Shandong Yinghng Medical Products Co., Ltd. · LZA · Aug 24, 2023 · General Hospital

Device Facts

• Record ID: K222103
• Device Name: Nitrile Patient Examination Gloves, Powder Free, Pink Color
• Applicant: Shandong Yinghng Medical Products Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 24, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Story

Nitrile patient examination glove; disposable; non-sterile; powder-free; pink color. Worn on hands/fingers by healthcare providers during examinations to provide barrier protection against contamination. Ambidextrous design; available in sizes XS through XXL. Manufactured from nitrile compound. Used in clinical settings; point-of-care environments. Provides physical barrier; prevents cross-contamination between patient and examiner.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing (ISO 10993-5, ISO 10993-10) confirmed non-cytotoxic, non-irritant, and non-sensitizing properties. Physical performance testing (ASTM D6319-19, D6124-06, D5151-19) confirmed compliance with requirements for dimensions, tensile strength, elongation, residual powder, and freedom from holes.

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, powder-free, pink, six sizes (XS-XXL). Standards: ASTM D6319-19 (dimensions, physical properties), ASTM D6124-06 (residual powder), ASTM D5151-19 (freedom from holes). Biocompatibility: ISO 10993-5, ISO 10993-10. Non-sterile. Standalone device.

Indications for Use

Indicated for use by medical examiners to prevent contamination between patient and examiner. Suitable for use on patients of all ages and genders.

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, Pink Color (K190942)

Submission Summary (Full Text)

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August 24, 2023

Shandong YINGHONG Medical Products Co., Ltd. % Jason Ji Official Correspondent Intco Medical Industries, Inc 805 Barrington Ave. Ontario. California 91764

Re: K222103

Trade/Device Name: Nitrile Patient Examination Gloves, Powder Free, Pink Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 11, 2022 Received: July 21, 2023

Dear Jason Ji:

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,

# Allan Guan -S

For 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K222103

Device Name

Nitrile Patient Examination Gloves, Powder Free, Pink Color

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands 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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# Shandong YINGHONG Medical Products Co., Ltd.

No.15 East Road, Hongrun Industry Park, Qingzhou, Shandong, China

# 510(K) SUMMARY K22103

# 1. Submitter's Identification:

Shandong YINGHONG Medical Products Co., Ltd No.15 East Road, Hongrun Industry Park, Qingzhou, Shandong, China

# Contact Person :

Emily Dong Tel: [phone]

# Submission Correspondent

Company: Intco Medical Industries, Inc 805 Barrington Ave Ontario, CA 91764 Primary Contact Name: Jason Ji Tel: [phone] (Ext: 113) Email: [e-mail] Secondary Contact: John Zhao Tel: [phone] (Ext:112) Email: [e-mail]

# Date summary prepared:

August 10, 2023

2.

Product Trade Name: Nitrile Patient Examination Gloves, Powder Free, Pink Color

#### 3. Device Classification Name:

Non-Powdered Patient Examination Gloves

- Regulation Number: 4. 21 CFR 880.6250
- રે. Device Class: Class I.
- Product Code: 6. LZA.
- 7. Predicate Devices: K190942 – Ever Growth (Vietnam) Co., Ltd.

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#### 8. Device Description:

The subject device in this 510(k) Notification is Nitrile Patient Examination Gloves, Powder Free, Pink Color. The subject device is a patient examination glove made from nitrile compound, pink color, powder free and non-sterile (Per 21 CFR 880.6250, class I).

These gloves are pink in color and are powder free. The gloves are ambidextrous single use disposable devices that come in six sizes (XS, S, M, L, XL and XXL).

#### Indications for Use: 9.

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.

| Characteristics<br>and Parameters | Shandong YINGHONG<br>Medical Products Co.,<br>Ltd.<br>Nitrile Patient<br>Examination Gloves,<br>Powder Free, Pink Color | Ever Growth (Vietnam) Co.,<br>Ltd.<br>Disposable Powder Free<br>Nitrile Examination Glove,<br>Pink Color | Comparison<br>Analysis |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| K-Number | K222103<br>(Subject Device) | K190942<br>(Predicate) | - |
| Product Code | LZA | LZA | Same |
| Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Intended use | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that is<br>worn upon the<br>examiner's hands or<br>finger to prevent<br>contamination between<br>patient and examiner. | The Nitrile Powder Free<br>patient examination glove is a<br>non- sterile disposable device<br>intended for medical purposes<br>that is worn on the examiner's<br>hands or finger to prevent<br>contamination between patient<br>and examiner. | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Pink | Pink | Same |
| Single Use | Yes | Yes | Same |
| Sterile vs<br>Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Powdered or<br>Powder Free | Powder Free | Powder Free | Same |
| | Complies with ASTM<br>D6319-19<br>Overall Length (mm)<br>For XS, S,<br>Min 220mm<br>For M, L, XL, XXL<br>Min 230mm | Complies with ASTM<br>D6319-10<br>Overall Length (mm)<br>For XS, S,<br>Min 220mm<br>For M, L, XL<br>Min 230mm | |
| | | | |
| Dimensions<br>ASTM<br>D6319-19 | Complies with<br>ASTM D6319-19<br>X-Small 70±10mm<br>Small 80±10mm<br>Medium 95±10mm<br>Large 110±10mm<br>X Large 120±10mm<br>XX Large 130 ±10mm | Complies with<br>ASTM D6319-10<br>X-Small 70±10mm<br>Small 80 ±10mm<br>Medium 95±10mm<br>Large 110±10mm<br>X Large 120 ±10mm<br>XX Large N/A | 1Different |
| | Thickness<br>Palm - 0.05mm min.<br>Finger - 0.05 mm min.<br>Meets ASTM D6319-19 | Thickness<br>Palm - 0.05mm min.<br>Finger - 0.05 mm min.<br>Meets ASTM D6319-10 | Same |
| Physical<br>properties<br>ASTM<br>D6319-19 | Tensile Strength:<br>Before Aging<br>14 MPa, min.<br>After Aging<br>14 MPa, min.<br><br>Elongation:<br>Before Aging 500% min.<br>After Aging 400% min. | Tensile Strength:<br>Before Aging<br>14 MPa, min.<br>After Aging<br>14 MPa, min.<br><br>Elongation:<br>Before Aging 500% min.<br>After Aging 400% min. | Similar |
| Freedom<br>from pinholes<br>ASTM<br>D6319-19<br>ASTM<br>D5151-19 | In accordance with<br>ASTM D6319-19 and<br>ASTM D5151- 19,<br>G-1, AQL 2.5 | In accordance with<br>ASTM D6319-10 and<br>ASTM D5151-06<br>G-1, AQL 2.5 | Similar |
| Residual<br>power test<br>ASTM<br>D6124-06 | Three Lot,<br>Average<br>power residue <2mg per<br>glove | Average powder residue<br>< 2mg per glove | Same |
| Skin Irritation<br>Test<br>ISO 10993-10 | Passed.<br>Under the conditions of<br>study, not an irritant. | Passed.<br>Under the conditions of study,<br>not an irritant. | Same |
| Skin<br>Sensitization<br>Test<br>ISO 10993-10 | Passed.<br>Under the conditions of<br>study, not a sensitizer | Passed.<br>Under the conditions of study,<br>not a sensitizer | Same |
| In Vitro<br>Cytotoxicity test<br>ISO 10993-5 | Passed<br>Under conditions of the<br>study, device extract is<br>non-cytotoxic | Passed<br>Under conditions of the<br>study, device extract is<br>non-cytotoxic | Same |

# 10. Technological Characteristics Comparison Table:

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1 The subject device sizes ranges from XS – XXL, whereas the predicate device size ranges from XS-XL. the predicate device. All sizes for the subject device meet the requirements of ASTM D6319-19.

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# 11. Discussion of Non-Clinical Tests:

Summary of Non-Clinical Testing

#### A Biocompatibility

- Biocompatibility Testing was performed according to the following tests for the subject device to evaluate the biocompatibility of Nitrile Patient Examination Gloves, Powder Free, Pink Color
- 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

#### > Performance Testing

Physical performance testing of the proposed device was conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves.

To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:

· ASTM D6319-19 Standard Specification for Nitrile Examination Gloves.

- 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.

| Test Method | Purpose | Acceptance Criteria | Results |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions<br>(length) (width)<br>(thickness)<br>ASTM<br>D6319-19 | The purpose of the test is<br>to evaluate the physical<br>dimension of the glove | Length<br>220 mm min (XS, S)<br>230 mm min (M, L, XL, XXL) | Pass<br>240 mm min |
| | | Width (mm)<br>XS: 70±10<br>S: 80±10<br>M: 95±10<br>L: 110±10<br>XL: 120±10<br>XXL: 130±10 | Pass<br>XS: average 78.4mm<br>S: average 86.2mm<br>M: average 97.4mm<br>L: average 108.7mm<br>XL: average 115.5mm<br>XXL: average 123.5mm |
| | | Thickness(mm):<br>Palm:Minimum 0.05<br>Finger:Minimum 0.05 | Pass<br>Palm - 0.056mm min.<br>Finger - 0.082mm min |
| Physical<br>properties<br>ASTM<br>D6319-19 | The purpose of the test is<br>to evaluate the tensile<br>strength and ultimate<br>elongation before and<br>after aging | Before Aging:<br>Tensile Strength: 14 MPa, min.<br>Elongation: 500%, min.<br>After Aging:<br>Tensile Strength: 14 MPa, min.<br>Elongation: 400%, min. | Pass<br>Before Aging:<br>Tensile Strength: 20.6MPa, min.<br>Elongation: 531%, min.<br>After Aging:<br>Tensile Strength: 21.9MPa, min.<br>Elongation: 416%, min. |
| | | Freedom<br>from holes<br>ASTM<br>D5151-19 | The purpose of the<br>test is to detect holes in<br>the gloves |
| Residual<br>Powder<br>ASTM<br>D6124-06 | The purpose of the test is<br>to detect the powder<br>residue in the glove | <2mg per glove | Pass<br>Average 0.15 mg per glove |
| In Vitro<br>Cytotoxicity<br>Test<br>ISO 10993-5 | To determine the cytotoxic<br>potential of the glove. | Under the conditions of the study, the<br>device is not cytotoxic | Pass<br>Under the conditions of the study, the<br>device have no cytotoxic effect |
| Skin<br>Sensitization<br>Test<br>ISO 10993-10 | To determine the skin<br>sensitization potential of<br>the glove. | Under the conditions of the study, the<br>device is not a sensitizer | Pass<br>Under the conditions of the study, the<br>device is not a sensitizer. |

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| Skin Irritation<br>Test<br>ISO 10993-10 | To determine the potential<br>of the glove under test to<br>produce irritation. | Under the conditions of the study, the<br>device is not an irritant | Pass<br>Under the conditions of the study, the<br>device is not an irritant. |
|-----------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------------|
|-----------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------------|

# 12. Discussion of Clinical Tests:

Not Applicable

## 13. Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that Shandong YINGHONG Medical Products Co., Ltd. Nitrile Patient Examination Gloves, Powder Free, Pink Color is as safe, as effective, and performs as well as or better than the legally marketed device, Disposable Powder Free Nitrile Examination Glove, Pink Color by Ever Growth (Vietnam) Co., Ltd., cleared under K190942.