Vinyl Co-Polymer Powder-free Examination Gloves, Black

K220240 · Grand Work Plastic Products Co., Ltd. · LYZ · Mar 31, 2022 · General Hospital

Device Facts

• Record ID: K220240
• Device Name: Vinyl Co-Polymer Powder-free Examination Gloves, Black
• Applicant: Grand Work Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Mar 31, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

Vinyl Co-Polymer 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.

Device Story

Disposable, non-sterile patient examination gloves; made of vinyl and oil-based liquid nitrile rubber. Worn by clinicians on hands/fingers to provide barrier protection against contamination between patient and examiner. Ambidextrous design; powder-free. Subject device is black; predicate is blue. Used in clinical/medical settings. Benefits include reduced risk of cross-contamination during examinations.

Clinical Evidence

No clinical data included. Bench testing only. Compliance with ASTM D5250-19, ASTM D412-16, ASTM D5151-19, and ASTM D6124-06(2017) verified. Biocompatibility testing per ISO 10993-10:2010 (skin irritation/sensitization), ISO 10993-5:2009 (cytotoxicity), and ISO 10993-11 (acute systemic toxicity) confirmed safety.

Technological Characteristics

Materials: Vinyl and oil-based liquid nitrile rubber. Ambidextrous, powder-free, non-sterile. Dimensions: Length ≥230mm; thickness ≥0.08mm. Performance standards: ASTM D5250-19, ASTM D412-16, ASTM D5151-19, ASTM D6124-06(2017). Biocompatibility: ISO 10993-5, ISO 10993-10, ISO 10993-11.

Indications for Use

Indicated for use as a disposable, non-sterile patient examination glove worn on the examiner's hand or finger 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

• Vinyl Co-Polymer Powder-free Examination Gloves, Blue color (K142409)

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 31, 2022

Grand Work Plastic Products Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710

Re: K220240

Trade/Device Name: Vinyl Co-Polymer 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: LYZ Dated: January 25, 2022 Received: January 28, 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.

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 Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K220240

#### Device Name

Vinyl Co-Polymer Powder-free Examination Gloves, Black

Indications for Use (Describe)

Vinyl Co-Polymer 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

Product: Vinyl Co-Polymer Powder-free Examination Gloves, Black

#### 510(K) SUMMARY

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

The assigned 510(K) number is: K220240 Date Prepared: March 24, 2022

#### 1. Owner's Identification:

Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: [phone]

Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: [phone]

#### 2. Name of the Device:

Trade Name: Vinyl Co-Polymer Powder-free Examination Gloves, Black Common Name: Patient Examination Glove Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LYZ Device Class: Class I

#### 3. Predicate Device Information:

Grand Work Plastic Products Co., Ltd. Vinyl Co-Polymer Powder-free Examination Gloves, Blue color - (K142409)

#### 4. Device Description:

Vinyl Co-Polymer 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. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-19 Standard Specification for Vinyl 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:

The subject device will be known as Vinyl Co-Polymer Powder-free Examination Gloves, Black.

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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

Product: Vinyl Co-Polymer Powder-free Examination Gloves, Black

The following tables are a comparison of the technological characteristics, biocompatibility of the subject and predicate devices.

General Comparison Table:

| # | Subject Device<br>(K220240) | Predicate Device<br>(K142409) | Comparison |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Trade Name | Vinyl Co-Polymer Powder-free Examination Gloves, Black | Vinyl Co-Polymer Powder-free Examination Gloves, Blue color | Similar |
| Product Code | LYZ | LYZ | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | Proposed Device 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. | Predicate device 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. | Same |
| Powder or Powder Free | Powder Free | Powder Free | Same |
| Materials | vinyl and oil-based liquid nitrile rubber | vinyl and oil-based liquid nitrile rubber | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Color | Black | Blue | Different |
| Single use | Single use | Single use | Same |

#### Dimensions and Performance Comparison Table:

| Technological<br>Characteristics | Subject Device<br>(K220240) | Predicate Device<br>(K142409) | Comparison |
|----------------------------------|--------------------------------|--------------------------------|------------|
| Length | Minimum 230mm for all<br>sizes | Minimum 230mm for<br>all sizes | Same |
| Palm Width (size) (mm) | | | |
| XS | $75\pm5$ | Not Applicable | Different |
| S | $85\pm5$ | $85\pm5$ | Same |
| M | $95\pm5$ | $95\pm5$ | Same |
| L | $105\pm5$ | $105\pm5$ | Same |
| XL | $115\pm5$ | $115\pm5$ | Same |
| Thickness(mm) | | | |
| Finger | Minimum 0.08 | Minimum 0.05 | Different |

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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

| Palm | Minimum 0.08 | Minimum 0.08 | Same |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-----------|
| Tensile Strength, Before<br>Aging | 11MPa, min | 11MPa, min | Same |
| Ultimate<br>Elongation, Before<br>Aging | 300%, min | 300%, min | Same |
| Tensile Strength, After<br>Accelerated Aging | 11MPa, min | 11MPa, min | Same |
| Ultimate Elongation,<br>After Accelerated<br>Aging | 300%, min | 300%, min | Same |
| Freedom from holes | G-I, AQL 2.5 | 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<br>the study, not an irritant | Under the conditions of<br>the study, not an irritant | Same |
| 10993-10:2010<br>Maximization<br>Sensitization Study | Under the conditions of<br>the study, not a sensitizer | Under the conditions of<br>the study, 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 no potential<br>cytotoxicity to L929 cells. | / | Different |
| ISO 10993 Part 11<br>Acute Systemic Toxicity<br>Test | It is concluded that the<br>extracts (polar and non-<br>polar) of the product did not<br>show any systemic toxicity | / | Different |

Product: Vinyl Co-Polymer Powder-free Examination Gloves, Black

There are no significant differences between the two products and are identical in terms of intended use and have similar materials, design, and manufacturing methods.

#### 7. Non-Clinical Performance Data

Non-clinical tests were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device complies with the following standards. The performance test data of the non-clinical tests for this glove are summarized below.

| Test method | Purpose | Acceptance Criteria | Results |
|----------------|------------|---------------------|---------------|
| ASTM D5250- 19 | Length | Minimum 230mm | All size ≥230 |
| ASTM D5250- 19 | Palm Width | XS: $75\pm5$ mm | XS: 76-78mm |
| | | S: $85\pm5$ mm | S: 86-88mm |
| | | M: $95\pm5$ mm | M:96-98mm |
| | | L: $105\pm5$ mm | L:106-108mm |
| | | XL: $115\pm5$ mm | XL: 116-118mm |

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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China

| ASTM D5250- 19 | Thickness | Finger: 0.08mm (min) | 0.08mm |
|-------------------------------------------|-------------------------------------------------|----------------------|------------------------------|
| | | Palm: 0.08mm (min) | 0.08-0.10mm |
| ASTM D5250-19<br>ASTN D412-16 | Tensile Strength, Before<br>Aging | 11MPa, min | 13.5-17.8 MPa |
| ASTM D5250-19<br>ASTN D412-16 | Tensile Strength, After<br>Accelerated Aging | 11MPa, min | 13.1-17.6 MPa |
| ASTM D5250-19<br>ASTN D412-16 | Ultimate Elongation, Before<br>Aging | 300%, min | 320-430% |
| ASTM D5250-19<br>ASTN D412-16 | Ultimate Elongation, After<br>Accelerated Aging | 300%, min | 310-420% |
| ASTM D 5151-19<br>ASTM D65250- 19 | Freedom from holes | G-I, AQL 2.5 | Meets AQL2.5<br>requirements |
| ASTM D 6124-<br>06(2017)<br>ASTM D5250 19 | Powder-Content | ≤2 mg per glove | 0.35-0.68 mg |

Product: Vinyl Co-Polymer Powder-free Examination Gloves, Black

#### 8. Clinical Performance Data

No Clinical study is included in this submission.

#### 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 K142409.