← Product Code [LZA](/productcode/LZA) · K213574

# Nitrile Vinyl Blend Powder Free Examination Gloves (Black) (K213574)

_Grand Work Plastic Products Co., Ltd. · LZA · Jul 12, 2022 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K213574

## Device Facts

- **Applicant:** Grand Work Plastic Products Co., Ltd.
- **Product Code:** [LZA](/productcode/LZA.md)
- **Decision Date:** Jul 12, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

## Device Story

Disposable, non-sterile, ambidextrous patient examination gloves; made of vinyl and oil-based liquid nitrile rubber blend; powder-free. Used in clinical settings by healthcare providers or patients to provide a flexible barrier film to prevent cross-contamination between examiner and patient. Available in sizes XS through XL. Performance verified against ASTM D6319-19 standards for physical dimensions, tensile strength, and freedom from holes.

## Clinical Evidence

No clinical data. Bench testing only. Testing included ASTM D6319-19 (dimensions, tensile strength, elongation, freedom from holes), ASTM D6124-06 (residual powder), and ISO 10993 series (biocompatibility: skin irritation, sensitization, cytotoxicity, and systemic toxicity).

## Technological Characteristics

Materials: vinyl and oil-based liquid nitrile rubber. Form factor: ambidextrous, powder-free, disposable gloves. Dimensions: length min 230mm, thickness min 0.05mm. Standards: ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-5, ISO 10993-10, ISO 10993-11.

## Regulatory 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

- Vinyl Nitrile Co-Polymer Powder Free Examination Gloves (Blue) ([K051662](/device/K051662.md))

## Submission Summary (Full Text)

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July 12, 2022

Grand Work Plastic Products Co., Ltd Donggao Industrial Zone, Zanhuang, Hebei 050000, China % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710

Re: K213574

Trade/Device Name: Nitrile Vinyl Blend Powder Free Examination Gloves (Black) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 14, 2022 Received: June 16, 2022

Dear Kathy Liu:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Bifeng Qian, M.D., Ph.D. Acting 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) K213574

#### Device Name

Nitrile Vinyl Blend Powder Free Examination Gloves (Black)

Indications for Use (Describe)

Nitrile Vinyl Blend Powder Free Examination Gloves (Black) is a disposable device intended for medical purposes that is worn on the examiner's hand 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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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

### K213574

Product: Nitrile Vinyl Blend Powder Free Examination Gloves (Black)

#### 510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR §807.92.

The assigned 510(K) number is: K213574

Date Prepared: July 12, 2022

#### 1. Owner's Identification:

Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: 86-311-66179668

Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611

#### 2. Name of the Device:

Trade Name: Nitrile Vinyl Blend Powder Free Examination Gloves (Black) Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LZA Device Class: Class I

#### 3. Predicate Device Information:

Grand Work Plastic Products Co., Ltd. Vinyl Nitrile Co-Polymer Powder Free Examination Gloves (Blue)- (K051662)

#### 4. Device Description:

Nitrile Vinvl Blend Powder Free Examination Gloves (Black) are Patient Examination Gloves. Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. They are ambidextrous and come in different sizes-XS, S, M, L and XL. The physical and performance characteristics of the devices meet all requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

#### 5. Intended Use of the Device:

A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

#### 6. Comparison of Subject Device and Predicate Device:

Grand Work Plastic Products Co. Ltd.'s Nitrile Vinyl Blend Powder Free Examination Gloves (Black) is safety and effectiveness as the Grand Work Plastic Products Co., Ltd.'s Vinyl Nitrile Co-Polymer Powder Free Examination Gloves (Blue)- (K051662). The subject device and predicate

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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

Product: Nitrile Vinyl Blend Powder Free Examination Gloves (Black)

device use a similar plastic flexible barrier film to achieve a device for the intended use. And the properties between the subject device and the predicate device are compared in the following table:

| #                        | Proposed Device<br>K213574                                                                                                                                                                                                   | Predicate Device<br>K051662                                                                                                                                                                                                                | Remark    |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Trade Name               | Nitrile Vinyl Blend Powder Free<br>Examination Gloves (Black)                                                                                                                                                                | Vinyl Nitrile Co-<br>Polymer Powder Free<br>Examination Gloves<br>(Blue)                                                                                                                                                                   | Similar   |
| Product Code             | LZA                                                                                                                                                                                                                          | LZA                                                                                                                                                                                                                                        | Same      |
| Regulation Number        | 21 CFR 880.6250                                                                                                                                                                                                              | 21 CFR 880.6250                                                                                                                                                                                                                            | Same      |
| Class                    | I                                                                                                                                                                                                                            | I                                                                                                                                                                                                                                          | Same      |
| Indications for Use      | Nitrile Vinyl Blend Powder Free<br>Examination Gloves (Black) is a<br>disposable device intended for<br>medical purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. | Vinyl Nitrile Co-<br>Polymer Powder Free<br>Examination Gloves<br>(Blue) is a disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hand to prevent<br>contamination between<br>patient and examiner. | Same      |
| Powder or Powder<br>Free | Powder Free                                                                                                                                                                                                                  | Powder Free                                                                                                                                                                                                                                | Same      |
| Materials                | vinyl and oil-based liquid nitrile<br>rubber                                                                                                                                                                                 | vinyl and oil-based<br>liquid nitrile rubber                                                                                                                                                                                               | Same      |
| Design Feature           | Ambidextrous                                                                                                                                                                                                                 | Ambidextrous                                                                                                                                                                                                                               | Same      |
| Color                    | Black                                                                                                                                                                                                                        | Blue                                                                                                                                                                                                                                       | Different |
| Labeling Information     | Single-use, powder free glove size, quantity, Examination Gloves, Non<br>Sterile                                                                                                                                             | Single-use, powder free<br>glove size, quantity,<br>Examination Gloves,<br>Non Sterile                                                                                                                                                     | Same      |

General Comparison Table:

Dimensions and Performance Comparison Table:

| Technological<br>Characteristics | Proposed Device | Predicate Device | Remark |
|----------------------------------|-----------------|------------------|--------|
| Length                           | Minimum 230mm   | Minimum 230mm    | Same   |
| Palm Width (size) (mm)           |                 |                  |        |
| XS                               | $70\u00b110$    | $70\u00b110$     | Same   |
| S                                | $80\u00b110$    | $80\u00b110$     | Same   |
| M                                | $95\u00b110$    | $95\u00b110$     | Same   |

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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

| L                                                    | 110±10                                                                                       | 110±10                                                                      | Same   |
|------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------|
| XL                                                   | 120±10                                                                                       | 120±10                                                                      | Same   |
| Thickness(mm)                                        |                                                                                              |                                                                             |        |
| Finger                                               | Minimum 0.05                                                                                 | Minimum 0.05                                                                | Same   |
| Palm                                                 | Minimum 0.05                                                                                 | Minimum 0.05                                                                | Same   |
| Tensile Strength, Before<br>Aging                    | 14MPa, min                                                                                   | 14MPa, min                                                                  | Same   |
| Ultimate Elongation,<br>Before Aging                 | 500%, min                                                                                    | 500%, min                                                                   | Same   |
| Tensile Strength, After<br>Accelerated Aging         | 14MPa, min                                                                                   | 14MPa, min                                                                  | Same   |
| Ultimate Elongation, After<br>Accelerated Aging      | 400%, min                                                                                    | 400%, min                                                                   | Same   |
| Freedom from holes                                   | In accordance with ASTM D 5151-19,<br>following ASTM D6319-19, G-I, AQL 2.5                  | In accordance with ASTM D 5151-19,<br>following ASTM D6319-19, G-I, AQL 2.5 | Same   |
| Powder-Content                                       | ≤2 mg per glove                                                                              | ≤2 mg per glove                                                             | Same   |
| 10993-10:2010 Skin<br>Irritation Study               | Under the conditions of the<br>study,<br>not an irritant                                     | Under the conditions of the<br>study,<br>not an irritant                    | Same   |
| 10993-10:2010<br>Maximization<br>Sensitization Study | Under the conditions of the<br>study,<br>not a sensitizer                                    | Under the conditions of the<br>study,<br>not a sensitizer                   | Same   |
| 10993-5:2009 In Vitro<br>Cytotoxicity Test           | Under the conditions of this<br>study, the test article extract<br>showed potential toxicity | /                                                                           | Exceed |
| ISO 10993 Part 11<br>Acute Systemic Toxicity<br>Test | Under the conditions of this<br>study, there was no evidence<br>of systemic toxicity.        | /                                                                           | Exceed |

Product: Nitrile Vinyl Blend Powder Free Examination Gloves (Black)

Grand Work Plastic Products Co., Ltd.'s Nitrile Vinyl Blend Powder Free Examination Gloves (Black) shares the same or comparable technology characteristics compared to the predicate device. The subject device performs according to the glove performance standards ASTM D6319-19, biocompatibility requirement and FDA requirements and the labeling claims for the product. It performs as well as the legally marketed predicate device.

#### 7. Non-Clinical Performance Data

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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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

Product: Nitrile Vinyl Blend Powder Free Examination Gloves (Black)

- 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 ●
- 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 method                            | Purpose                                         | Acceptance Criteria        | Results                                                                         |
|----------------------------------------|-------------------------------------------------|----------------------------|---------------------------------------------------------------------------------|
| ASTM D6319- 19                         | Length                                          | All size:<br>Minimum 230mm | XS: 230-245mm<br>S: 230-245mm<br>M: 230-245mm<br>L: 230-245mm<br>XL: 230-247 mm |
| ASTM D6319- 19                         | Palm Width                                      | XS: 70±10mm                | 76-78mm                                                                         |
|                                        |                                                 | S: 80±10mm                 | 86-88 mm                                                                        |
|                                        |                                                 | M:95±10mm                  | 96 -98mm                                                                        |
|                                        |                                                 | L:110±10mm                 | 106-110 mm                                                                      |
|                                        |                                                 | XL: 120±10mm               | 116-118 mm                                                                      |
| ASTM D6319- 19                         | Thickness                                       | Finger: 0.05mm (min)       | 0.06-0.08mm                                                                     |
|                                        |                                                 | Palm: 0.05mm (min)         | 0.07-0.09mm                                                                     |
| ASTM D6319-19<br>ASTN D412-16          | Tensile Strength, Before<br>Aging               | 14MPa, min                 | 14.2-16.9 MPa                                                                   |
| ASTM D6319-19<br>ASTN D412-16          | Tensile Strength, After<br>Accelerated Aging    | 14MPa, min                 | 14.1-16.2MPa                                                                    |
| ASTM D6319-19<br>ASTN D412-16          | Ultimate Elongation,<br>Before Aging            | 500%, min                  | 500-520%                                                                        |
| ASTM D6319-19<br>ASTN D412-16          | Ultimate Elongation, After<br>Accelerated Aging | 400%, min                  | 400-480%                                                                        |
| ASTM D 5151-19<br>ASTM D6319- 19       | Freedom from holes                              | G-I, AQL 2.5               | XS: 0/125<br>S:0/125<br>M: 0/125<br>L:1/125<br>XL: 1/125                        |
| ASTM D 6124-06(2017)<br>ASTM D6319- 19 | Powder-Content                                  | ≤ 2 mg per glove           | XS:0.35mg<br>S: 0.41mg<br>M: 0.47mg<br>L: 0.55mg                                |

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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

|                   |                                     |                                                                                        | XL: 066mg                                                                              |
|-------------------|-------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| ISO 10993-10:2010 | Skin Irritation Study               | Under the conditions of the study, not an irritant                                     | Under the conditions of the study, not an irritant                                     |
| ISO 10993-10:2010 | Maximization<br>Sensitization Study | Under the conditions of the study, not a sensitizer                                    | Under the conditions of the study, not a sensitizer                                    |
| ISO 10993-5:2009  | Cytotoxicity Test                   | Under the conditions of this study, the test article extract showed potential toxicity | Under the conditions of this study, the test article extract showed potential toxicity |
| ISO 10993-11:2017 | Systemic toxicity                   | Under the conditions of this study, there was no evidence of systemic toxicity.        | Under the conditions of this study, there was no evidence of systemic toxicity.        |

Product: Nitrile Vinyl Blend Powder Free Examination Gloves (Black)

### 8. Clinical Performance Data

N/A

### 9. Conclusion:

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

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**Source:** [https://fda-staging.innolitics.com/device/K213574](https://fda-staging.innolitics.com/device/K213574)

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