Powder Free Black Nitrile Examination Glove

K201428 · Vietglove Corporation · LZA · Jun 24, 2021 · General Hospital

Device Facts

• Record ID: K201428
• Device Name: Powder Free Black Nitrile Examination Glove
• Applicant: Vietglove Corporation
• Product Code: LZA · General Hospital
• Decision Date: Jun 24, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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.

Device Story

Powder Free Black Nitrile Examination Glove; disposable nitrile (acrylonitrile-butadiene) glove; worn on examiner's hand/finger; prevents cross-contamination between patient and examiner; used in medical settings; over-the-counter use. Device provides physical barrier protection; tested for barrier integrity, physical properties, and biocompatibility. Benefits patient and examiner by reducing risk of contamination during examinations.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified via ASTM D6319-10 (physical properties), ASTM D6124-06 (residual powder), ASTM D5151-06 (freedom from holes), and ISO 10993-10/11 (biocompatibility).

Technological Characteristics

Material: Nitrile (acrylonitrile-butadiene). Design: Ambidextrous, finger-textured, black color. Standards: ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, ISO 10993-10, ISO 10993-11, ISO 2859-1. Non-sterile, powder-free. Physical properties: Tensile strength >14 MPa, ultimate elongation >500% (before aging).

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Suitable for over-the-counter use.

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 Blue Nitrile Examination Glove (K153562)

Submission Summary (Full Text)

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June 24, 2021

Vietglove Corporation Terence Lim Quality Assurance & Regulatory Affairs Manager Cau Sat Hamlet, Lai Hung Commune, Bau Bang District, Binh Duong Province Bingh Duong, Bingh Duong Province 72600 Viet Nam

Re: K201428

Trade/Device Name: Powder Free Black Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: May 25, 2021 Received: May 27, 2021

Dear Terence Lim:

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.

For Ryan Ortega, 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 Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K201428

Device Name POWDER FREE BLACK NITRILE EXAMINATION GLOVE

Indications for Use (Describe)

A 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.

| 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

## K201428

| 1.0 | Submitter | Vietglove Corporation | |
|-----|-----------|----------------------------------|--|
| | | Cau Sat Hamlet, Lai Hung Commune | |

Cau Sat Hamlet, Lai Hung Commune Bau Bang District Binh Duong Province

| Tel: | [phone] |
|------|----------------|
| Fax: | [phone] |

## 2.0

Name of Contact Person: Terence Lim Email Address: limsinkooi@@gmail.com Date of Summary Prepared: May 17, 2021

#### 3.0 Name of Device:

510(k) number K201428 Trade Name: Powder Free Black Nitrile Examination Glove Classification Name: Polymer Patient Examination Glove Device Classification: 21 CFR 880.6250 Regulation Number: General Hospital Panel: Product Code: LZA

#### 4.0 Identification of The Legally Marketed Device

Predicate Device Name: Powder Free Blue Nitrile Examination Glove

Predicate 510(K) Number: K153562

Manufacturer's Name: VIETGLOVE CORPORATION

#### 5.0 Description of Device

Powder Free Black Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

#### 6.0 The Intended Use/Indications for Use

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

#### 7.0 Summary of the Technological Characteristic of the Device compared to the Predicate Device for Substantial Equivalent Discussion.

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## VIETGLOVE CORPORATION

Cau Sat Hamlet, Lai Hung Commune, Bau Bang District ,Binh Duong Province Vietnam

There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-Sterile, Powder Free Blue Nitrile Examination Gloves has the below technological characteristic compared to ASTM or Equivalent standards.

## Comparison On Technological Characteristic Between The Predicate Device And Subject Devices

| Characteristics and<br>Parameters | Proposed Device -<br>Powder Free Nitrile<br>Examination Gloves<br>(K201428) | Predicate Device -<br>Powder Free Blue<br>Nitrile Examination<br>Gloves (K153562 ) | Discussion |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Product Code | LZA | LZA | Same product Code |
| Intended<br>Use<br>/<br>Indications for Use | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that<br>is worn on the hand or<br>finger to prevent<br>contamination between<br>patient and examiner. | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that<br>is worn on the hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner. | Same Intended Use. |
| Classification | Class 1 | Class 1: | Same Class. |
| Raw Rubber Material | Nitrile (Acrylonitrile-<br>butadiene) | Nitrile (Acrylonitrile-<br>butadiene) | Same synthetic rubber<br>material. |
| Surface Appearance | 1.Black<br>2. Ambidextrous<br>3.Finger Textured | 1.Blue<br>2. Ambidextrous<br>3.Finger Textured | 1. Different color<br>2. Same ambidextrous<br>design<br>3. Same texture area. |
| Freedom of Holes<br>Meet AQL 2.5 at G1 | Meet AQL 1.5 with<br>G1 | Meet AQL 1.5 with<br>G1. | Similar |
| Overall Length<br>Minimum 230mm | Average : 242mm | More than 230mm | Similar |
| Width<br>S : 75mm - 95mm<br>M: 85mm - 105mm<br>L: 100mm – 120mm | Average :<br>S : 85 mm<br>M : 95 mm<br>L : 104 mm | Meeting<br>specification | Similar |
| Palm Thickness<br>(Minimum 0.05mm) | Average : 0.06mm | More than 0.05mm | Similar |
| Finger Thickness<br>(Minimum 0.05mm) | Average : 0.11mm | More than 0.05mm | Similar |
| Tensile Strength<br>(before age)<br>Minimum 14 MPa | Average : 17.44 MPa | More than 14 MPa | Similar |
| Tensile Strength<br>(After Age)<br>Minimum 14 MPa | Average : 16.37 MPa | More than 14 MPa | Similar |
| Characteristics and<br>Parameters | Proposed Device -<br>Powder Free Nitrile<br>Examination Gloves<br>(K201428) | Predicate Device -<br>Powder Free Blue<br>Nitrile Examination<br>Gloves (K153562 ) | Discussion |
| Ultimate Elongation<br>before age<br>(Minimum 500%) | Average : 559% | Minimum 500% | Similar |
| Ultimate Elongation<br>after age<br>(Minimum 400%) | Average : 508% | Minimum 400% | Similar |
| Residual powder test<br>(Less than<br>2mg/glove) | Average powder<br>residue for each size:<br>S : 0.43 mg/glove<br>M : 0.31 mg/glove<br>L : 0.47 mg/glove | Contained less than<br>2mg/glove | Similar |
| Primary Skin Irritation | Under the conditions<br>of study, not an<br>irritant | Under the conditions<br>of study, not an<br>irritant | Similar |
| Dermal Sensitization | Under the conditions<br>of study, not a<br>sensitizer. | Under the conditions<br>of study, not a<br>sensitizer. | Similar |
| Cytotoxicity | Cytotoxic | N/A | Different |
| Acute Systemic<br>Toxicity | Not induce systemic<br>toxicity | N/A | Meeting the requirements<br>per ISO 10993-11 |

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## VIETGLOVE CORPORATION

Cau Sat Hamlet, Lai Hung Commune, Bau Bang District ,Binh Duong Province Vietnam

## Summary of Non-Clinical Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. 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.
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic . toxicitv
- ASTM D6124-06, Standard Test Method for Residual Powder on Medical Gloves .
- ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves. ●
- ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application .
- ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes Part I: Sampling Plans ● Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.

## Clinical Test Conclusion

No clinical test is included in this submission.

### Conclusion

The conclusion drawn from the nonclinical tests demonstrates the subject device in 510(K) submission K201428, Powder Free Black Nitrile Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153562.