Disposable Nitrile Examination Glove

K223281 · Anhui Kindguard Medical Supplies Technology Co., Ltd. · LZA · Dec 7, 2022 · General Hospital

Device Facts

• Record ID: K223281
• Device Name: Disposable Nitrile Examination Glove
• Applicant: Anhui Kindguard Medical Supplies Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Dec 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Disposable nitrile examination glove; worn by healthcare examiners to prevent cross-contamination between patient and examiner. Device is non-sterile, ambidextrous, and powder-free; available in five sizes (XS, S, M, L, XL). Manufactured from nitrile material; blue colorant. Used in clinical settings; operated by healthcare professionals. Provides physical barrier protection. Performance verified via bench testing against ASTM and ISO standards.

Clinical Evidence

No clinical data. Bench testing only. Compliance demonstrated with ASTM D6319 (physical dimensions/properties), ASTM D5151 (watertightness/holes), ASTM D6124 (residual powder), and ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation, systemic toxicity).

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, powder-free, five sizes. Standards: ASTM D6319 (dimensions/physical properties), ASTM D5151 (holes), ASTM D6124 (powder content), ISO 10993-5/10/11/23 (biocompatibility). Non-sterile. No software or electronic components.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands 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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 7, 2022

Anhui Kindguard Medical Supplies Technology 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: K223281

Trade/Device Name: Disposable Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: October 21, 2022 Received: October 25, 2022

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.

{1}------------------------------------------------

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 and Part 809); 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 Qian -S

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K223281

Device Name Disposable Nitrile Examination Glove

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------|----------------------------------------------|
| <div> <span> <span></span> </span> </div> | Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92. The assigned 510(k) number is K223281.

#### 1.0 Submitter's Information

Name: Anhui Kindguard Medical Supplies Technology Co., Ltd Address: Southwest of Intersection of Tonghe RD & HWY 343, The Economic Dvpt. Zone, Si County, 234300 Suzhou, Anhui, PEOPLE'S REPUBLIC OF CHINA Phone Number: [phone] Contact: Guo Hua Date of Preparation: Oct.21, 2022

#### Designated Submission Correspondent

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

#### 2.0 Device Information

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

#### 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

{4}------------------------------------------------

#### 5.0 Indication for Use

The Disposable Nitrile Examination Glove is a disposable device 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.

It can be available in five specifications: XS, S, M, L and XL. The subject device is non-sterile.

#### 7.0 Technological Characteristic Comparison Table

| Table1-General Comparison | | | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------|
| Item | Subject Device<br>(K223281) | Predicated Device<br>(K171422) | Remark | |
| Product Code | LZA | LZA | Same | |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same | |
| Class | I | I | Same | |
| Intended Use /<br>Indications for Use | The Disposable Nitrile<br>Examination Glove is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's hands<br>to prevent contamination<br>between patient and<br>examiner. | The Disposable Powder Free<br>Nitrile Examination Glove,<br>White/ Blue/ Black/ Pink Color<br>is a disposable device<br>intended for medical<br>purposes that is worn on the<br>examiner's hands to prevent<br>contamination between<br>patient and examiner. | Same | |
| Material | Nitrile | Nitrile | Same | |
| Powdered or<br>Powered free | Powdered free | Powdered free | Same | |
| Design Feature | Ambidextrous | Ambidextrous | Same | |
| Colorant | Blue | White/ Blue/ Black/ Pink | Different<br>Analysis 1 | |
| Labeling Information | Single-use indication, powder<br>free, device color, device<br>name, glove size and<br>quantity, Non-Sterile | Single-use indication, powder<br>free, device color, device<br>name, glove size and<br>quantity, Non-Sterile | Same | |
| Dimensions(mm) | Length:<br>XS/S:≥220; M/L/XL:≥230; | Length:<br>S/M/L/XL:≥230; | Different<br>Analysis 2 | |
| | | Width: | Width: | |
| | | XS: 70±10; | XS: 75±5; | |
| | | S: 80±10; | S: 85±5; | |
| | | M: 95±10; | M: 95±5; | |
| | | L: 110±10; | L: 105±5; | |
| | | XL: 120±10 | XL: 115±5 | |
| | Thickness(mm) | Finger: ≥0.05;<br>Palm: ≥0.05 | Finger: ≥0.05;<br>Palm: ≥0.05 | Same |
| | | | | |
| Physical<br>Properties | Before<br>Aging | Tensile<br>Strength | Tensile<br>Strength | Same |
| | | $14MPa$ , min | $14MPa$ , min | |
| | | Ultimate<br>Elongation | Ultimate<br>Elongation | |
| | | 500% min | 500% min | Same |
| | After<br>Aging | Tensile<br>Strength | Tensile<br>Strength | Same |
| | | $14MPa$ , min | $14MPa$ , min | |
| | | Ultimate<br>Elongation | Ultimate<br>Elongation | |
| | | 400%min | 400%min | Same |
| Freedom from Holes | | Be free from holes when<br>tested in accordance with<br>ASTMD5151 AQL=2.5 | Be free from holes when<br>tested in accordance with<br>ASTMD5151 AQL=2.5 | Same |
| Powder Content | | Meet the requirements of<br>ASTM D6124 | Meet the requirements of<br>ASTM D6124 | Same |
| Biocompatibility | | ISO 10993-10;<br>Under the conditions of the<br>study, not a sensitizer<br>ISO 10993-23<br>Under the conditions of the<br>study, not an irritant<br>ISO 10993-5<br>Under conditions of the study,<br>device extract is cytotoxic<br>ISO 10993-11;<br>Under the<br>condition of acute<br>systemic toxicity test,<br>the test article did not<br>show acute systemic<br>toxicity in vivo | ISO 10993-10;<br>Under the conditions of the<br>study, not an irritant or a<br>sensitizer | Different<br>Analysis 3 |
| | | / | / | |
| | | | | |
| | | / | / | |
| | | | | |

#### Table1-General Comparison

{5}------------------------------------------------

Analysis 1: The subject device (Blue) has different color to the predicate device (White/ Blue/ Black/ Pink), but all proposed devices are conducted the biocompatibility test.

Analysis 2: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319.

{6}------------------------------------------------

Analysis 3: The subject device conducted the irritation test under the ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation, while the predicate device conducted the irritation test under the old edition ISO 10993-10. But under the conditions of the study, both of the devices are not irritant.

### 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 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.

ISO 10993-10 Fourth edition 2021-11, Biological evaluation of medical devices - Part 10: Tests for skin sensitization.

ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation.

ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

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>Method | Purpose | Acceptance Criteria | Results |
|----------------|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM<br>D6319 | Physical<br>Dimensions<br>Test | Length (mm):<br>XS/S: ≥220;<br>M/L/XL: ≥230;<br>Width (mm):<br>XS: 70±10;<br>S: 80±10;<br>M: 95±10;<br>L: 110±10;<br>XL: 120±10.<br>Thickness (mm):<br>Finger: ≥0.05 | Length(mm):<br>> 230/Pass;<br>Width(mm):<br>XS: 74-77 / Pass<br>S: 85-86 / Pass<br>M: 94-97 / Pass<br>L: 103-108 / Pass<br>XL:114-118 / Pass<br>Thickness (mm):<br>Finger: |

Table 2 - Summary of non-clinical performance testing

{7}------------------------------------------------

| | | | Palm: ≥0.05 | | 0.08-0.09/Pass |
|-----------------|--------------------------------------------------|---------------------------------------------|---------------------|--------|--------------------------------------------------------------------------------------|
| | | | | | Palm: |
| | | | | | 0.06-0.07/Pass |
| ASTM<br>D5151 | Watertightness Test for<br>Detection of<br>Holes | Meet the requirements of ASTM D5151 AQL 2.5 | | | 0/125/Pass |
| ASTM<br>D6124 | Powder<br>Content | Meet the requirements of ASTM D6124 < 2.0mg | | | 0.29-0.33mg/Pass; |
| ASTM<br>D412 | Physical<br>properties | Before Aging | Tensile Strength | ≥14MPa | 14-30 MPa/Pass; |
| | | | Ultimate Elongation | ≥500% | 509-586 %/Pass; |
| | | After Aging | Tensile Strength | ≥14MPa | 14-25 MPa/Pass; |
| | | | Ultimate Elongation | ≥400% | 418-533 %/Pass; |
| ISO<br>10993-5 | Cytotoxicity | Non-Toxicity | | | Under conditions of the study, device extract is cytotoxic. |
| ISO<br>10993-11 | Acute<br>systemic<br>toxicity | Non-acute systemic<br>toxicity | | | Under conditions of` the study, did not show acute systemic toxicity in vivo. / Pass |
| ISO<br>10993-23 | Irritation | Non-irritating | | | Under the conditions of the study, not an irritant. / Pass |
| ISO<br>10993-10 | Sensitization | Non-sensitizing | | | Under conditions of the study, not a sensitizer. / Pass |

### 9.0 _Summary of Clinical Testing

Clinical testing is not needed for this device.

{8}------------------------------------------------

#### 10.0 Conclusion

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