Synguard Nitrile Exam Glove

K220442 · Tianjin Aoshang Outdoor Equipment Co., Ltd. · LZA · May 12, 2022 · General Hospital

Device Facts

• Record ID: K220442
• Device Name: Synguard Nitrile Exam Glove
• Applicant: Tianjin Aoshang Outdoor Equipment Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: May 12, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Synguard Nitrile Exam 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.

Device Story

Disposable, non-sterile, blue nitrile examination glove; worn by clinicians or examiners on hands/fingers. Acts as physical barrier to prevent contamination between patient and examiner. Used in clinical settings. Provides protection during patient examinations. Manufactured from acrylonitrile and butadiene; available in sizes S, M, L, XL. Meets ASTM D6319-19 standards for physical dimensions, tensile strength, and elongation. Single-use device.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified via ASTM D6319-19 (physical dimensions, tensile strength, elongation), ASTM D5151-19 (freedom from holes), ASTM D6124-06 (residual powder), and ISO 10993-10/11 (biocompatibility: irritation, sensitization, systemic toxicity).

Technological Characteristics

Material: Acrylonitrile, Butadiene. Non-sterile, single-use, blue, powder-free. Dimensions/Physical properties per ASTM D6319-19, ASTM D3767-03, ASTM D412-16. Freedom from holes per ASTM D5151-19. Biocompatibility per ISO 10993-10:2010 and ISO 10993-11:2017.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger 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

• Powder Free Nitrile Examination Gloves, Blue (colored) (K172015)

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.

May 12, 2022

Tianjin Aoshang Outdoor Equipment Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd. P.O.box 120-119 Shanghai. 200120 China

Re: K220442

Trade/Device Name: Synguard Nitrile Exam Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 11, 2022 Received: February 16, 2022

Dear Diana Hong:

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,

Clarence W. Murray, III, PhD 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K220442

Device Name Synguard Nitrile Exam Glove

Indications for Use (Describe)

Synguard Nitrile Exam 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.

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

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K220442

- 1. Date of Preparation: 02/11/2022
- 2. Sponsor Identification

Tianjin Aoshang Outdoor Equipment Co., Ltd. C-1-106, No.23 Xiangtan Road, Hongqiao District, Tianjin

Contact Person: Xiaoning Zhang Position: QS Engineer Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

## Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

#### 4. Identification of Proposed Device

Trade Name: Synguard Nitrile Exam Glove Common Name: POWDER FREE NITRILE EXAMINATION GLOVES

Regulatory Information

Classification Name: polymer patient examination glove

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Classification: I; Product Code: LZA; Regulation Number: 21CFR 880.6250 Review Panel: General Hospital;

Indication for Use:

Synguard Nitrile Exam 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.

Device Description

The proposed device is a powder free medical glove. The device is blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in four sizes, which are S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.

- ડ. Identification of Predicate Device
510(k) Number: K172015

Product Name: Powder Free Nitrile Examination Gloves, Blue (colored)

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#### 6. Technological Characteristics Comparison

| ITEM | Subject Device<br>K220442 | Predicate Device<br>K172015 | Comparison | | |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|------------|-----------|
| Product Code | LZA | LZA | Same | | |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | | |
| Class | I | I | Same | | |
| Indication for use | Synguard Nitrile Exam Glove is a<br>disposable device intended for<br>medical purposes that is worn on the<br>examiner's hand or finger to prevent<br>contamination between patient and<br>examiner. | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn on the<br>examiner's hand or finger to prevent<br>contamination between patient and<br>examiner. | Same | | |
| Material | Acrylonitrile, Butadiene | Nitrile | Different | | |
| Color | Blue | Blue | Same | | |
| Sterility | Non-sterile | Non-sterile | Same | | |
| Single-use | Yes | Yes | Same | | |
| Size | S, M, L, XL | XS, S, M, L, XL | | | |
| | Width | | | | |
| | / | XS | $70\pm10mm$ | | |
| | S | $84\pm5mm$ | $80\pm10mm$ | | |
| | M | $94\pm5mm$ | $95\pm10mm$ | | |
| | L | $110\pm5mm$ | $110\pm10mm$ | | |
| | XL | $120\pm5mm$ | $120\pm10mm$ | | |
| | Length | | | | |
| Dimensions<br>(ASTM D6319-19) | / | XS | 220mm min | Different | |
| | S | 230mm | 220mm min | | |
| | M | 230mm | 230mm min | | |
| | L | 240mm | 230mm min | | |
| | XL | 240mm | 230mm min | | |
| | Thickness | | | | |
| | Palm | 0.05mm min | Palm | 0.05mm min | |
| | Finger | 0.05mm min | Finger | 0.05mm min | |
| | Before Aging | | | | |
| Physical Properties<br>(ASTM D6319-19<br>and ASTM<br>D412-16) | Tensile Strength | 14MPa min | Tensile Strength | 14MPa min | Same |
| | Ultimate Elongation | 500% min | Ultimate Elongation | 500% min | |
| | After Aging | | | | |
| | Tensile Strength | 14MPa min | Tensile Strength | 14MPa min | |
| | Ultimate Elongation | 400% min | Ultimate Elongation | 400% min | |
| Power free residue<br>(ASTM D6319-19<br>and ASTM<br>D6124-06) | Less than 2mg per glove | | Less than 2mg per glove | | Same |
| Freedom from<br>Holes (ASTM<br>D5151-19) | No water leakage occurs. | | Before aging: Meet AQL 1.5<br>After aging: Meet AQL 2.5 | | Different |
| Biocompatibility | | | | | |
| Skin Irritation | No Irritation | | No Irritation | | |
| Sensitization | No Sensitization | | No Sensitization | | Different |
| Systemic Toxicity | No Toxicity | | / | | |

## Table 1 Comparison of Technology Characteristics

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### Different- Material

The material of the proposed device is different from predicate device.

### Different- Size& Dimensions

The size and dimension of the proposed device is not exactly same as the predicate device.

### Different- Freedom from Holes

The performance description of freedom from holes of the proposed device is different from predicate device.

#### Different- Biocompatibility

The biocompatibility test item of the proposed device is different from the predicate device.

#### 7. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the performance of the proposed device met all design specifications of the applicable and current standards. The test results demonstrated that the proposed device complies with the following standards:

- > ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- > ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- > ASTM D3767-03 (2020) Standard Practice for Rubber-Measurement of Dimensions
- > ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- > ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- > ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;

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

| Test Methodology | Purpose | Acceptance Criteria | | Results<br>(Pass/Fail) | |
|-------------------------------------------|------------------------|---------------------|------------------------|------------------------|------|
| ASTM D6319-19,<br>ASTM D3767-03<br>(2020) | Physical<br>Dimensions | Width | S | 84±5mm | Pass |
| | | | M | 94±5mm | |
| | | | L | 110±5mm | |
| | | | XL | 120±5mm | |
| | | Length | S | 230mm | |
| | | | M | 230mm | |
| | | | L | 240mm | |
| | | | XL | 240mm | |
| | | Thickness | Palm | 0.05mm min | |
| | | | Finger | 0.05mm min | |
| ASTM D6319-19,<br>ASTM D412-16 | Physical Properties | Before Aging | Tensile<br>Strength | 14MPa min | Pass |
| | | | Ultimate<br>Elongation | 500% min | |
| | | After Aging | Tensile<br>Strength | 14MPa min | |
| | | | Ultimate | 400% min | |

### Table 2 Summary of non-clinical performance testing

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| | | Elongation | |
|-------------------|-----------------------|--------------------------------------------------------------------------------------------------------------|------|
| ASTM D5151-19 | Freedom from<br>Holes | Be free from holes when tested in accordance<br>with ASTM D5151 | Pass |
| ASTM D6124-06 | Powder free residue | Less than 2mg per glove | Pass |
| ISO 10993-10:2010 | Irritation | The polar and nonpolar device extracts did not<br>cause an irritation response in the animal<br>model. | Pass |
| ISO 10993-10:2010 | Sensitization | The polar and nonpolar device extracts did not<br>cause a sensitizing response in the animal<br>model. | Pass |
| ISO 10993-11:2009 | System toxicity | The polar and nonpolar device extracts did not<br>cause a systemic toxicity response in the<br>animal model. | Pass |

#### 8. Clinical Test Conclusion

No clinical study is included in this submission.

#### 9. Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K172015.