Disposable Nitrile Examination Glove

K223250 · Yangzhou Saraguard Medical Supplies Co., Ltd. · LZA · Jan 19, 2023 · General Hospital

Device Facts

• Record ID: K223250
• Device Name: Disposable Nitrile Examination Glove
• Applicant: Yangzhou Saraguard Medical Supplies Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jan 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The disposable nitrile medical examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination glove; non-sterile; ambidextrous; available in blue or white; sizes XS-XL. Used in clinical settings by healthcare providers to prevent cross-contamination between patient and examiner. Device acts as a physical barrier. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated per ASTM D6319-19 (physical dimensions, tensile strength, elongation), ASTM D6124-06 (residual powder), and ASTM D5151-19 (freedom from holes). Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-11 (acute systemic toxicity), and ISO 10993-23 (irritation).

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, non-sterile, powder-free gloves. Sizes: XS, S, M, L, XL. Colors: Blue, White. Standards: ASTM D6319-19, ASTM D6124-06, ASTM D5151-19. Biocompatibility: ISO 10993-5, 10, 11, 23.

Indications for Use

Indicated for use by medical examiners to prevent cross-contamination between patient and examiner. Suitable for use on hands or fingers.

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)

Reference Devices

• Nitrile examination gloves (K203593)

Submission Summary (Full Text)

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January 19, 2023

Yangzhou Saraguard Medical Supplies Co.,Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China

Re: K223250

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: December 20, 2022 Received: December 20, 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.

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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); 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

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### Indications for Use

510(k) Number (if known) K223250

Device Name Disposable Nitrile Examination Glove

Indications for Use (Describe)

The disposable nitrile medical examination glove is a non-sterile disposable device intended for medical purposes that is 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

# K223250

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

#### 1.0 Submitter's Information

Yangzhou Saraguard Medical Supplies Co.,Ltd. Name: Standard Workshop No. 1, Phase I, Comprehensive Bonded Zone, No. 9, Address: Yangtze Jiangnan Road, Yangzhou City, Jiangsu Province, China Phone Number: [phone] Contact: Guo Hua Date of Preparation: Oct.21,2022

#### Designated Submission Correspondent

Mr. Boyle Wanq 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 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

#### Predicate Device#:

| Manufacturer: | Ever Global (Vietnam) Enterprise Corp |
|---------------|----------------------------------------------------------------------------------|
| Device: | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color |

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510(k) number: K171422

#### Reference Device#:

Manufacturer: GUANG DONG KINGFA SCI. & TECH.CO., LTD. Device: Nitrile examination gloves 510(k) number: K203593

#### 5.0 Indication for Use

The disposable nitrile medical examination glove is a non-sterile disposable device intended for medical purposes that is 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 subject device is available in color blue and white, and it provides five specifications: XS,S,M,L and XL. The subject device is non-sterile.

#### 7.0 Technological Characteristic Comparison Table

#### Table1-General Comparison

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| Item | Subject Device | Predicate Device | Reference Device | Remark |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | LZA | LZA | LZA | Same |
| 510(k) Reference | K223250 | K171422 | K203593 | |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | I | Same |
| Intended<br>Use/Indication for Use | The disposable nitrile<br>medical<br>examination<br>glove is a non-sterile<br>disposable<br>device<br>intended for medical<br>purposes that is worn on<br>the examiner's hands or<br>finger to prevent<br>contamination between<br>patient and examiner. | The Nitrile powder free<br>patient examination Glove,<br>is a non-sterile disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hands or finger to prevent<br>contamination between<br>patient and examiner. | The nitrile examination<br>glove is intended to be worn<br>on the hands of examiners<br>to prevent contamination<br>between patient and<br>examiner. This is a single-<br>use, powder-free, non-<br>sterile device. | Same |
| Powdered or Powered<br>free | Powdered free | Powdered free | Powdered free | Same |
| Device material<br>composition | Nitrile | Nitrile | Nitrile | Same |
| Gloves sizes | XS,S,M,L,XL | XS,S,M,L,XL | S,M,L,XL | Same |
| If gloves are single<br>use | Yes | Yes | Yes | Same |
| Design Feature | Ambidextrous | Ambidextrous | Ambidextrous | Same |
| Sterile vs Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Color | Blue/White | White/ Blue/ Black/ Pink | Blue | Similar |
| Dimensions - Length | Complies with ASTM<br>D6319-19:<br>XS/S: ≥220 mm;<br>M/L/XL: ≥230 mm. | Complies with ASTM<br>D6319-19: ≥230 mm. | Complies with ASTM<br>D6319-19:<br>S:≥220;<br>M/L/XL: ≥230 | Similar |
| Dimensions - Width | Complies with ASTM<br>D6319-19:<br>XS: 70±10mm;<br>S:80±10mm;<br>M:95±10mm;<br>L: 110±10mm;<br>XL: 120±10mm; | Complies with ASTM<br>D6319-19:<br>XS: 75±5mm;<br>S:85±5mm;<br>M:95±5mm;<br>L: 105±5mm;<br>XL: 115±5mm; | Complies with ASTM<br>D6319-19:<br>S: 80±10mm;<br>M: 95±10mm;<br>L: 110±10mm;<br>XL: 120±10mm | Similar |
| Dimensions -<br>Thickness | Complies with ASTM<br>D6319-19<br>Palm:≥0.05mm<br>Finger: ≥0.05mm | Complies with ASTM<br>D6319-19<br>Palm:≥0.05mm<br>Finger: ≥0.05mm | Complies with ASTM<br>D6319-19<br>Palm:≥0.05mm<br>Finger: ≥0.05mm | Same |
| Physical Properties -<br>Tensile Strength | Complies with ASTM<br>D6319-19:<br>Before Aging: ≥14MPa<br>After Aging: ≥500% | Complies with ASTM<br>D6319-19:<br>Before Aging: ≥14MPa<br>After Aging: ≥500% | Complies with ASTM<br>D6319-19:<br>Before Aging: ≥14MPa<br>After Aging: ≥500% | Same |
| Physical Properties -<br>Elongation | Complies with ASTM<br>D6319-19:<br>Before Aging: ≥14MPa<br>After Aging: ≥400% | Complies with ASTM<br>D6319-19:<br>Before Aging: ≥14MPa<br>After Aging: ≥400% | Complies with ASTM<br>D6319-19:<br>Before Aging: ≥14MPa<br>After Aging: ≥400% | Same |
| Freedom from Holes | Complies with ASTM<br>D6319-19<br>and ASTM D5151-19 | Complies with ASTM<br>D6319-19<br>and ASTM D5151-19 | Complies with ASTM<br>D6319-19<br>and ASTM D5151-19 | Same |
| | G-1, AQL 2.5 | G-1, AQL 2.5 | G-1, AQL 2.5 | |
| Powder Content | Complies with ASTM D6319-19, < 2 mg per glove | Complies with ASTM D6319-19. | Complies with ASTM D6319-19. | Same |
| Biocompatibility<br>- Irritation Test | ISO 10993-23;<br>Under the conditions of the study, not an irritant | Comply with Comply with ISO10993-10 | ISO 10993-23;<br>Under the conditions of the study, not an irritant | Same |
| Biocompatibility<br>- Sensitization Test | ISO 10993-10;<br>Under the conditions of the study, not a sensitizer | Comply with Comply with ISO10993-10 | ISO 10993-10;<br>Under the conditions of the study, not a sensitizer | Same |
| Biocompatibility<br>- Acute Systemic<br>Toxicity | ISO 10993-11;<br>Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo. | N/A | ISO 10993-11;<br>Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo. | Different |
| Biocompatibility<br>-Cytotoxicity | ISO 10993-5<br>Under conditions of the study, device extract is cytotoxic | Not Publicly Available | ISO 10993-5<br>Under conditions of the study, device extract is cytotoxic | Different |

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#### Analysis:

The color(blue/white) of the subject device is different with those (white/ blue/ black/ pink) of the predicate device, biocompatibility test has been performed on subject device and the test result can meet the requirements of ISO 10993 standards.

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The physical dimensions are little different with that of the predicate, but they all meet the requirements of ASTM D6319. Therefore, the differences will not raise any safety and effectiveness issues.

For the Biocompatibility- Cytotoxicity and Acute Systemic Toxicity, at the neat extraction, the current device is considered cytotoxic, but the acute systemic toxicity results demonstrate the device will not cause a systemic effect, this situation is same with the reference device. So there is no effect on the substantial equivalence to the predicate device.

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#### 8.0 Summary of Non-Clinical Testing

#### Biocompatibility Testing

The biocompatibility evaluation for Nitrile Powder Free Examination Gloves, was conducted in accordance with the following standards:

ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: T Part 10: Tests for skin sensitization.

ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation;

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

ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

| Test Method | Purpose | Acceptance Criteria | Results |
|--------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-23:2021 Tests<br>For Irritation | To determine if device is a<br>skin irritant | The device must be a<br>non-irritant | Pass |
| ISO 10993-10:2021 Tests<br>For Skin Sensitization | To determine if device is a<br>skin sensitizer | The device must be a<br>non- sensitizer | Pass |
| ISO 10993-5:2009<br>Tests For In Vitro<br>Cytotoxicity | To determine if the device<br>is potential toxicity to L-929<br>cells. | The device must be a<br>non toxicity. | Cytotoxic |
| ISO 10993-11:2017 Tests<br>for Acute systemic toxicity | To determine if the device<br>will cause acute systemic<br>toxicity in vivo | The device must be a<br>Non- acute systemic<br>toxicity | Pass |
| Test<br>Method | Purpose | Acceptance Criteria | Results |
| ASTM<br>D6319 | Physical<br>Dimensions<br>Test | Length(mm):<br>S:≥220;<br>M/L/XL:≥230;<br>Width(mm):<br>XS: 70±10mm;<br>S:80±10mm;<br>M:95±10mm;<br>L: 110±10mm;<br>XL: 120±10mm | Length:<br>> 240/Pass;<br>Width:<br><b>Blue color:</b><br>XS: 74-76 /Pass<br>S: 82-86 /Pass<br>M: 95-97/ Pass<br>L: 104-106/ Pass<br>XL:115-117/ Pass<br><b>White Color:</b><br>XS: 73-76 /Pass<br>S: 80-87 /Pass<br>M: 100-103/ Pass<br>L: 104-106/ Pass<br>XL:114-117/ Pass |
| | | Thickness (mm):<br>Finger: ≥0.05<br>Palm: ≥0.05 | <b>Blue color:</b><br>XS:<br>Finger:0.10-0.12/Pass<br>Palm: 0.06-0.10/Pass<br>S:<br>Finger: 0.09-0.12/Pass<br>Palm:0.07-0.09/Pass<br>M:<br>Finger: 0.08 -0.12/Pass<br>Palm: 0.07-0.09/Pass<br>L:<br>Finger: 0.09-0.12/Pass<br>Palm: 0.06-0.09/Pass<br>XL:<br>Finger: 0.11-0.12/Pass<br>Palm: 0.06-0.09/Pass<br><b>White Color:</b><br>XS: |

#### Table 2 Biocompatibility Testing

#### Performance Testing (Bench)

Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.

In summary, 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 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 -

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Medical Application.

## Table 3 Non-Clinical Testing

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| | After<br>Aging | Tensile<br>Strength | $\geq$ 14MPa | Blue color:<br>20-30/Pass.<br>White Color:<br>16-35/Pass. |
|--|----------------|------------------------|--------------|--------------------------------------------------------------|
| | | Ultimate<br>Elongation | $\geq$ 400% | Blue color:<br>511-565/Pass<br>White Color:<br>436-521/Pass. |

#### 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 is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K171422.