Disposable Nitrile Medical Examination Glove

K211131 · Siyang Threeguard Medical Supplies Co., Ltd. · LZA · Jul 29, 2021 · General Hospital

Device Facts

• Record ID: K211131
• Device Name: Disposable Nitrile Medical Examination Glove
• Applicant: Siyang Threeguard Medical Supplies Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jul 29, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Disposable Nitrile Medical 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 on examiner's hands; provides protective barrier; prevents cross-contamination between patient and examiner. Used in medical settings; non-sterile; ambidextrous design; blue color. Manufactured from nitrile material; powder-free. Device serves as physical barrier; performance verified through physical property testing (tensile strength, elongation), watertightness (hole detection), and biocompatibility assessments. No clinical data required; safety and effectiveness established via bench testing against ASTM standards.

Clinical Evidence

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

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, powder-free, blue, non-sterile. Dimensions: Length ≥230mm; Width 75-115mm (size dependent); Thickness ≥0.05mm. Standards: ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-5:2009, ISO 10993-10:2010. No software or electronic components.

Indications for Use

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

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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 29, 2021

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

Re: K211131

Trade/Device Name: Disposable Nitrile Medical Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 23, 2021 Received: June 28, 2021

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 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,

For Clarence W. Murray, III, 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 Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K211131

Device Name Disposable Nitrile Medical Examination Glove

Indications for Use (Describe)

The Disposable Nitrile Medical 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

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 (K211131)

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

#### 1.0 Submitter's Information

Name: Siyang Threeguard Medical Supplies Co.,Ltd. Address: East of Nanhai Road and South of Guilin Road,Economic Development Zone, Siyanq County,Sugian City,Jiangsu,223799 China. Phone Number: [phone] Contact: Guo Hua Date of Preparation: July.29,2021

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

#### 3.0 Classification

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

#### 4.0 Predicate Device Information

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

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510(k) number: K171422

#### 5.0 Indication for Use

The Disposable Nitrile Medical 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. The subject device is non-sterile.

#### 7.0 Technological Characteristic Comparison Table

| Item | Subject Device<br>(K211131) | Predicate Device<br>(K171422) | Remark |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | Disposable Nitrile<br>Medical<br>Examination Glove<br>is a disposable<br>device 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 |
| Labeling Information | Single-use<br>indication, powder<br>free, device color,<br>device name,<br>glove size and<br>quantity | Single-use<br>indication, powder<br>free, device color,<br>device name, glove<br>size and quantity,<br>Non-Sterile | Same |

#### Table1-General Comparison

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| | Non-Sterile | | | |
|--|-------------|--|--|--|
|--|-------------|--|--|--|

| Predicate<br>Device(K171422) | Designation | Size | | | | | Tolerance | |
|------------------------------|-------------|------|-----|-----|-----|-----|-----------|--|
| | | XS | S | M | L | XL | | |
| | Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
| | Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | | | | | | | | |
| | Finger | 0.05 | | | | | min | |
| | Palm | 0.05 | | | | | min | |
| Subject Device<br>(K211131) | Designation | Size | | | | | Tolerance | |
| | | XS | S | M | L | XL | | |
| | Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
| | Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | | | | | | | | |
| | Finger | 0.05 | | | | | min | |
| | Palm | 0.05 | | | | | min | |
| Remark | Same | | | | | | | |

# Table2 Device Dimensions Comparison

# Table3 Performance Comparison

| Table3 Performance Comparison | | | | | |
|-------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------|------------|------|
| Item | Subject device<br>(K211131) | Predicate device<br>(K171422) | Remark | | |
| Colorant | Blue | White/ Blue/<br>Black/ Pink | Same | | |
| 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 |
| | Comply with ASTM D6319 | | Comply with<br>ASTM<br>D6319 | Same | |
| Freedom from Holes | Be free from<br>holes when<br>tested in<br>accordance<br>with<br>ASTMD5151<br>AQL=2.5 | Be free from<br>holes when<br>tested in<br>accordance<br>with<br>ASTMD5151<br>AQL=2.5 | Same | | |

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| Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | Meet the requirements of ASTM D6124 | Same |
|----------------|---------------------------------------------|-------------------------------------|------|
|----------------|---------------------------------------------|-------------------------------------|------|

#### Table4 Safety Comparison

| Item | | Subject<br>device<br>(K211131) | Predicate<br>device<br>(K171422) | Remark |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------|---------|
| Material | | Nitrile | Nitrile | Same |
| Biocompatibility | Irritation (ISO<br>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 | | |
| | 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<br>a sensitizer. | Comply with<br>ISO10993-<br>10 | Same |
| | Cytotoxicity (ISO<br>10993-5:2009<br>Biological<br>Evaluation of<br>Medical Devices -<br>Part 5: Tests For<br>In Vitro<br>Cytotoxicity) | Under<br>conditions of<br>the study,<br>device<br>extract is not<br>cytotoxic | / | Similar |

#### 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 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

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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.

| Test<br>Methodology | Purpose | Acceptance Criteria | Results |
|---------------------|-----------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| ASTM D6319 | Physical<br>Dimensions<br>Test | Length(mm):<br>≥230; | Length:>230 |
| | | Width(mm):<br>XS: 75±5;<br>S: 85±5;<br>M: 95±5;<br>L: 105±5;<br>XL: 115±5 | Width:<br>XS: 77-79;<br>S: 82-86<br>M: 95-97<br>L: 104-106<br>XL: 115-117<br>Pass |
| | | Thickness (mm):<br>Finger: ≥0.05<br>Palm: ≥0.05 | XS:<br>Finger: 0.10-0.12<br>Palm: 0.06-0.10 |
| | | | S:<br>Finger: 0.09-0.12<br>Palm: 0.07-0.09 |
| | | | M:<br>Finger: 0.08-0.12<br>Palm: 0.06-0.09 |
| | | | L:<br>Finger: 0.09-0.13<br>Palm: 0.06-0.09 |
| | | | XL:<br>Finger: 0.11-0.12<br>Palm: 0.06-0.08<br>Pass |
| ASTM D5151 | Watertightness<br>Test for<br>Detection of<br>Holes | Meet the requirements of<br>ASTM D5151 AQL 2.5 | XS:<br>0/125 leaks<br>S:1/125 leaks<br>M:0/125 leaks |

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| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | | | XS:0.01mg/glove;<br>S:0.02mg/glove;<br>M:0.03mg/glove;<br>L:0.01mg/glove;<br>XL:0.02mg/glove;<br>Pass | | | | |
|------------|---------------------|---------------------------------------------|---------------------|---------------------|-------------------------------------------------------------------------------------------------------|---------------|--|--|----------------------------------------------------------------------------------------|
| ASTM D412 | Physical properties | Before Aging | Tensile Strength | ≥14MPa | XS:15.3-16.3<br>S:15.6-19.2<br>M:15.9-17.3<br>L:15.3-17.2<br>XL:15.3-17.1<br>Pass | | | | |
| | | | Ultimate Elongation | ≥500% | XS: 525-579<br>S:518-571<br>M:515-575<br>L:521-562<br>XL:523-568<br>Pass | | | | |
| | | | After Aging | Tensile Strength | ≥14MPa | | | | |
| | | | | Ultimate Elongation | ≥400% | | | | |
| | | | | ISO 10993-5 | Cytotoxicity | Non-cytotoxic | | | Under conditions of the study, did not show potential toxicity to L-929 cells.<br>Pass |

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| ISO 10993-10 | Irritation | Non-irritating | Under the<br>conditions of the<br>study, not an irritant.<br>Pass |
|--------------|---------------|-----------------|-------------------------------------------------------------------|
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of<br>the study, not a<br>sensitizer.<br>Pass |

## 9.0 _Summary of Clinical 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.