Nitrile Examination Gloves (Blue, Violet Blue, White)

K202402 · Jiangsu Tianshuo Medical Products Co., Ltd. · LZA · Mar 1, 2021 · General Hospital

Device Facts

• Record ID: K202402
• Device Name: Nitrile Examination Gloves (Blue, Violet Blue, White)
• Applicant: Jiangsu Tianshuo Medical Products Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Mar 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White) 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 gloves; worn on examiner's hands; barrier protection to prevent cross-contamination between patient and examiner. Available in blue, violet blue, and white; various sizes (XS-XL). Used in clinical settings by healthcare professionals. Physical properties meet ASTM D6319 standards for tensile strength and elongation. Biocompatibility verified via ISO 10993-5 and ISO 10993-10 testing to ensure no irritation or sensitization from colorants.

Clinical Evidence

Bench testing only. Compliance with ASTM D6319-15 (physical properties), ASTM D5151-06 (freedom from holes), and ASTM D6124-17 (residual powder). Biocompatibility testing per ISO 10993-10:2010 (irritation and sensitization) and ISO 10993-5:2009 (in vitro cytotoxicity) confirmed no adverse biological response.

Technological Characteristics

Material: Nitrile. Standards: ASTM D6319-15, ASTM D5151-06, ASTM D6124-17. Biocompatibility: ISO 10993-5, ISO 10993-10. Form factor: Disposable, ambidextrous, powder-free gloves. Thickness: 0.05 mm (finger, palm, cuff). Tensile strength: 15 MPa (before aging), 14 MPa (after aging).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands to prevent 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 GLOVES (White, Cobalt Blue, Black, Ice Blue) (K150340)

Submission Summary (Full Text)

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March 1, 2021

Jiangsu Tianshuo Medical Products Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K202402

Trade/Device Name: Nitrile Examination Gloves (Blue, Violet Blue, White) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: January 28, 2021 Received: February 1, 2021

Dear Ray 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 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.

Ryan Ortega, PhD Acting Assistant Director CDHT4B: 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved : 0MB No. 0910-0120 Expiration Date:06/30/2023 See PRA Statement below.

510(k) Number (if known) K202402

Device Name

NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White)

Indications for Use (Describe)

The NITRILE EXAMINATION GLOVES (Blue, Violet Blue, \Vhite) 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)

D Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: K202402

- 1. Date of Preparation: 08/19/2020
- 2. Sponsor

#### Jiangsu Tianshuo Medical Products Co., Ltd.

No. 78, North Longjin Road, Sucheng Economic Development Area, Suqian City, Jiangsu Province, China Contact Person: Gao Feng Position: Business Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- Submission Correspondent 3.
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401

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

- Proposed Device Identification 4.
Trade Name: NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White) Common Name: NITRILE Patient Examination Gloves (Powder Free)

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

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Indication For Use Statement:

The NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

- 5. Predicate Device Identification
510(k) Number: K150340 Product Name: POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) Manufacturer: HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD

- 6. Device Description
The proposed device, NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed devices are NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White) includes variations of different size and color. The colors of the proposed device are Blue, and White.

| Designation | SIZE | | | | | Tolerance |
|----------------|------|-----|-----|-----|-----|-----------|
| | XS | S | M | L | XL | |
| Length (mm) | 230 | 230 | 230 | 235 | 235 | Min. |
| Width (mm) | 70 | 80 | 95 | 110 | 120 | ±10 (mm) |
| Thickness (mm) | | | | | | |
| Finger | 0.05 | | | | | Min. |
| Palm | 0.05 | | | | | Min. |
| Cuff | 0.05 | | | | | Min. |

#### Table 1 Device Size Specifications

| Before Aging | | After Aging | | Pinhole AQL |
|------------------|---------------------|------------------|---------------------|-------------|
| Tensile Strength | Ultimate Elongation | Tensile Strength | Ultimate Elongation | 1.5 |
| 15 MPa, min | 500 % min | 14 MPa, min | 500 % min | |

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The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319.

- 7. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM D6319-15, Standard Specification for Nitrile Examination Gloves for Medical Application. ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves. ASTM D6124-17, 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.

ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.

- 8. Technology Comparison Table

| | Proposed Device (K202402) | Predicate Device (K150340) | |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| ITEM | NITRILE EXAMINATION GLOVES | POWDER FREE Nitrile GLOVES (White, | Remark |
| | (Blue, Violet Blue, White) | Cobalt Blue, Black, Ice Blue) | |
| Product Code | LZA | LZA | SAME |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME |
| Class | I | I | SAME |
| Intended Use | The Powder free Nitrile Examination<br>Gloves NITRILE EXAMINATION<br>GLOVES (Blue, Violet Blue, White) is a<br>disposable device intended for medical<br>purposes that is worn on the examiner's<br>hands to prevent contamination between<br>patient and examiner. | The POWDER FREE Nitrile GLOVES<br>(White, Cobalt Blue, Black, Ice Blue) is a<br>disposable device intended for medical<br>purposes that is worn on the examiner's<br>hands to prevent contamination between<br>patient and examiner. | SAME |
| Powered free | Powdered free | Powdered free | SAME |

#### Table 3 General Comparison

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| | | Size | | | | | |
|---------------------------------------------------------------------|----------------|-----------|-----|-----|-----|-----|-----------|
| Proposed Device | Designation | XS | S | M | L | XL | Tolerance |
| NITRILE EXAMINATION GLOVES<br>(Blue, Violet Blue, White) | Length, mm | 230 | 230 | 230 | 235 | 235 | min |
| | Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | | Min. |
| | Palm | 0.05 | | | | | Min. |
| | Cuff | 0.05 | | | | | Min. |
| Predicate Device (K150340) | | Size | | | | | |
| POWDER FREE Nitrile GLOVES<br>(White, Cobalt Blue, Black, Ice Blue) | Designation | XS | S | M | L | XL | Tolerance |
| | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
| | Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 |
| | Thickness, mm: | | | | | | |
| | Finger | 0.10-0.12 | | | | | ±0.03 |
| | Palm | 0.08-0.10 | | | | | ±0.03 |
| | Cuff | 0.06-0.09 | | | | | ±0.03 |

Table 4 Device Dimensions Comparison

Table 5 Performance Comparison

| ITEM | Proposed Device<br>NITRILE EXAMINATION GLOVES<br>(Blue, Violet Blue, White) | Predicate Device (K150340)<br>POWDER FREE Nitrile GLOVES<br>(White, Cobalt Blue, Black, Ice Blue) | Remark | |
|------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------|---------|
| Colorant | Blue, Violet Blue, White | White, Cobalt Blue, Black, Ice Blue | Similar | |
| Physical<br>Properties | Before Aging | | | |
| | Tensile Strength | 15 MPa, min | 15 MPa, min | SAME |
| | Ultimate Elongation | 500 % min | 500 % min | SAME |
| | After Aging | | | |
| | Tensile Strength | 14 MPa, min | 14 MPa, min | SAME |
| | Ultimate | 500 % min | 400 % min | Similar |

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| | | Elongation | | | |
|--------------------|--|-----------------------------------------------------------------------|--|-----------------------------------------------------------------|------|
| | | Comply with ASTM D6319 | | Comply with ASTM D6319 | SAME |
| Freedom from Holes | | Be free from holes when tested in<br>accordance with ASTM D5151 | | Be free from holes when tested in<br>accordance with ASTM D5151 | SAME |
| | | | | | |
| Powder Content | | Less than 2 mg per glove when tested<br>in accordance with ASTM D6124 | | Meet the requirements of ASTM<br>6319 | SAME |
| | | | | | |

The proposed device has different color to the predicate device, this different may causes potential biocompatibility risk, for this risk we conducted the biocompatibility test according to the ISO 10993-10 and ISO 10993-5, the test results showed that the proposed devices with blue colorant did not induce skin irritation and showed no significant evidence of causing skin sensitization.

The proposed device has different Tensile Strength before aging specification to the predicate device, but all proposed device meets the specification requirements of ASTM D 6319.

| ITEM | Proposed Device(K202402) | Predicate Device (K150340) | Remark | |
|------------------|-------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------|------|
| | NITRILE<br>EXAMINATION<br>GLOVES (Blue, Violet Blue, White) | POWDER FREE Nitrile GLOVES<br>(White, Cobalt Blue, Black, Ice Blue) | | |
| Material | Nitrile | Nitrile | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study,<br>not an irritant | Under the conditions of the study,<br>not an irritant | SAME |
| | Sensitization | Under conditions of the study, not a<br>sensitizer. | Under conditions of the study, not a<br>sensitizer. | |
| | Acute<br>Systemic<br>Toxicity | Under conditions of the study, not<br>toxic | Not Available | |

## Table 6 Safety Comparison

## 9. 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 predicate device.