Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)

K222498 · Humanwell Healthcare Group Medical Supplies Co., Ltd. · LZA · Oct 26, 2022 · General Hospital

Device Facts

• Record ID: K222498
• Device Name: Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
• Applicant: Humanwell Healthcare Group Medical Supplies Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 26, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Medical Examination Glove (Nitrile) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Medical Examination Gloves (Nitrile) are non-sterile, single-use, disposable gloves designed to prevent cross-contamination between patients and examiners. Manufactured from nitrile material, the gloves are ambidextrous and available in sizes XS, S, M, L, and XL. They are intended for use in medical environments by healthcare personnel or for general use. The device functions as a physical barrier. Performance is verified through compliance with ASTM D6319-19 standards for dimensions, tensile strength, and elongation. The gloves are blue, powder-free, and packaged in paper boxes. They provide a protective barrier for the examiner's hands during medical examinations.

Clinical Evidence

No clinical data. Bench testing only. Performance demonstrated via ASTM D6319-19 (dimensions, physical properties), ASTM D6124-06 (residual powder), and ASTM D5151-19 (freedom from holes). Biocompatibility verified via ISO 10993-10 (irritation, sensitization) and ISO 10993-11 (acute systemic toxicity).

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, powder-free, blue, non-sterile. Standards: ASTM D6319-19 (dimensions/physical properties), ASTM D6124-06 (residual powder), ASTM D5151-19 (freedom from holes). Biocompatibility: ISO 10993-10, ISO 10993-11. Dimensions: Length 220-230mm, Palm/Finger thickness 0.05mm min.

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. Suitable for use by healthcare professionals and in over-the-counter 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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October 26, 2022

Humanwell Healthcare Group Medical Supplies Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th F, 1500# Century Avenue Shanghai. 200122 China

Re: K222498

Trade/Device Name: Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 18, 2022 Received: August 18, 2022

Dear Ivy 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Bifeng Oian, 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K222498

Device Name

Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)

Indications for Use (Describe)

The Medical Examination Glove (Nitrile) is a disposable device intended for medical purposes that is 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)

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

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K222498

## 510(K) Summary

(As requirement by 21 CFR 807.92)

Date prepared: 2022-10-25

#### A. Applicant:

Name: Humanwell Healthcare Group Medical Supplies Co., Ltd.

Address: 169 Shendun Yi Lu, East Lake Hi-tech Development Zone, Wuhan, Hubei Province, People's Republic of China Contact: Ms. Aixue Yao

Title: Sales Manager

Tel: [phone]

Email: [e-mail]

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail]

### B. Device:

Trade Name: Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) Common Name: Nitrile Patient Examination Gloves (Powder Free)

Regulatory Information Classification Name: Polymer Patient Examination Glove Classification: Class I Product code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

### C. Predicate device:

K171422 Disposable Powder Free Nitrile Examination Glove, White/Blue/ Black/ Pink Color Ever Global (Vietnam) Enterprise Corp

### D. Indications for use of the device:

The Medical Examination Glove (Nitrile) is a disposable device intended for medical purposes that is worn on

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# K222498

the examiner's hand to prevent contamination between patient and examiner.

#### E. Device Description:

The Medical Examination Gloves (Nitrile) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in sizes extra-small, small, medium, large, extra-large packed in a paper box.

The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard.

#### F. Summary of Technological Characteristics

Table 1 General Comparison of Proposed and Predicate Devices

| Device | Proposed Device | Predicate Device | Result |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| 510K # | K222498 | K171422 | - |
| Product Name | Medical Examination Gloves (Nitrile) | Disposable<br>Powder<br>Free<br>Nitrile<br>Examination<br>Glove,<br>White/Blue/<br>Black/ Pink Color | - |
| Product Code | LZA | LZA | Same |
| Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications<br>for<br>use | The Medical Examination Glove (Nitrile) is a<br>disposable device intended for medical<br>purposes that is worn on the examiner's hand<br>to prevent contamination between patient<br>and examiner. | The Disposable Powder Free Nitrile<br>Examination Glove, White/ Blue/ Black/<br>Pink Color is a disposable device<br>intended for medical purposes that is<br>worn on the examiner's hands to<br>prevent contamination between patient<br>and examiner. | Same |
| Powder free | Yes | Yes | Same |
| Design feature | Ambidextrous | Ambidextrous | Same |
| Material | Nitrile | Nitrile | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Single use | Single use | Same |
| Label | Single-use, indication, powder free, device<br>color, device name, glove size and quantity,<br>Nitrile Glove Powder Free Blue, Non-Sterile | Single-use, indication, powder free,<br>device color, device name, glove size and<br>quantity, Disposable Powder Free<br>Nitrile Examination Glove, Non-Sterile | Same |

Table 2 Device dimension comparison

| Predicate<br>device<br>(K171422) | Designation | Size | | | | | Tolerance |
|----------------------------------|-------------|------|-----|-----|-----|-----|-----------|
| | | XS | S | M | L | XL | |
| | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
| | Width, mm | 75 | 85 | 90 | 105 | 115 | $\u00b15$ |

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| | Thickness, mm | | | | | | |
|--------------------|---------------|----------|-----|-----|-----|-----|-----------|
| | Finger | 0.05 min | | | | | |
| | Palm | 0.05 min | | | | | |
| Proposed<br>device | Designation | Size | | | | | Tolerance |
| | | XS | S | M | L | XL | |
| | Length, mm | 220 | 220 | 230 | 230 | 230 | min |
| | Width, mm | 70 | 80 | 95 | 110 | 120 | $\pm$ 10 |
| | Thickness, mm | | | | | | |
| | Finger | 0.05 min | | | | | |
| | Palm | 0.05 min | | | | | |
| Result | 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.

| Item | Proposed device | Predicate device (K171422) | Result | |
|---------------------|-------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|------|
| Colorant | Blue | White/ Blue/ Black/ Pink | Similar | |
| Physical properties | Before aging Tensile strength | 14MPa, min | 14MPa, min | Same |
| | Ultimate elongation | 500%, min | 500%, min | Same |
| | After aging Tensile strength | 14MPa, min | 14MPa, min | Same |
| | Ultimate elongation | 400%, min | 400%, min | Same |
| | Comply with ASTM D6319 | | Comply with ASTM D6319 | Same |
| Freedom from holes | | Be free from holes when tested in accordance with ASTM D5151 G-1, AQL 2.5 | Be free from holes when tested in accordance with ASTM D5151 G-1, AQL 2.5 | Same |
| Residual Powder | | Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Same |

Table 3 Performance comparison

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.

#### Table 4 Biocompatibility comparison

| Item | | Proposed device | Predicate device<br>(K171422) | Result |
|------------------|----------------------------|--------------------------------|-------------------------------|--------|
| Material | | Nitrile | Nitrile | Same |
| Biocompatibility | Irritation<br>ISO 10993-10 | Under the<br>conditions of the | Comply with ISO<br>10993-10 | Same |

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| | study, not an<br>irritant. Comply<br>with ISO 10993-10. | |
|--------------------------------------------|--------------------------------------------------------------------------------------------|-----------|
| Sensitization<br>ISO 10993-10 | Under the<br>conditions of the<br>study, not a<br>sensitizer. Comply<br>with ISO 10993-10. | |
| Acute systemic<br>toxicity<br>ISO 10993-11 | Under the /<br>conditions of the<br>study, the device is<br>non-toxic. | Different |

Analysis: Toxicity 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.

### G. Summary of Non-Clinical Testing

#### A Biocompatibility

The following tests for the subject device were conducted the biocompatibility of Medical Nitrile Examination Gloves:

- ISO 10993-10: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- · ISO 10993-11: Acute Systemic Toxicity

| Test | Purpose | Acceptance Criteria | Results |
|--------------------------------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------|
| Irritation<br>ISO 10993-10 | The purpose of the test is to verify<br>that the proposed device extract is<br>non-irritating. | Under the conditions of the<br>study, not an irritant. | Pass |
| Sensitization<br>ISO 10993-10 | The purpose of the test is to verify<br>that the proposed device extract is<br>non-sensitizing | Under the conditions of the<br>study, not a sensitizer. | Pass |
| Acute systemic<br>toxicity<br>ISO 10993-11 | The purpose of the test is to verify<br>that the proposed device extract is<br>non-cytotoxic. | Under the conditions of the<br>study, the device is non-toxic. | Pass |

#### A Performance Testing

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

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

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# K222498

| Test Method | Purpose | Acceptance Criteria | Results |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions (width)<br>(thickness) | The purpose of the<br>test is to evaluate<br>the physical<br>dimension of the<br>glove | Width 70mm min<br>Length 220mm min<br>Palm - 0.05mm min.<br>Finger-0.05mm min. | Pass<br>76mm min width<br>234mm min length<br>Pass<br>Palm - 0.08mm min.<br>Finger-0.09mm min |
| Physical properties | The purpose of the<br>test is to evaluate<br>the tensile strength<br>and ultimate<br>elongation before<br>and after aging | Tensile Strength:<br>Before Aging $\geq$ 14 MPa, min.<br>After Aging $\geq$ 14 MPa, min.<br>Elongation:<br>Before Aging 500%, min.<br>After Aging 400%, min. | Pass<br>Tensile Strength:<br>Before Aging 24.44 MPa, min.<br>After Aging 27.21 MPa, min.<br>Elongation:<br>Before Aging 513%, min.<br>After Aging 541%, min. |
| Freedom from holes | The purpose of the<br>test is to detect<br>holes in the gloves | No leakage at sampling level of<br>G-1, AQL 2.5 | Pass<br>No leakage, 80 of 80 passed of<br>each size |
| Residual Powder | The purpose of the<br>test is to detect the<br>powder residue in<br>the glove | <2mg per glove | Pass<br>average 0.84 mg per glove |

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

### H. Clinical Test Conclusion

No clinical study is included in this submission.

#### l. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Medical Examination Gloves (Nitrile) are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K171422.