Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)

K202356 · Kanglongda Vietnam Protection Technology Company Limited · LZA · Mar 2, 2021 · General Hospital

Device Facts

• Record ID: K202356
• Device Name: Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)
• Applicant: Kanglongda Vietnam Protection Technology Company Limited
• Product Code: LZA · General Hospital
• Decision Date: Mar 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder free Nitrile Examination Gloves (Blue, White, Cobalt Blue) 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 by clinicians/examiners to prevent cross-contamination between patient and examiner. Device is non-sterile; available in multiple sizes (XS-XL) and colors (Blue, Violet Blue, White, Cobalt Blue). Physical properties include tensile strength and elongation meeting ASTM D6319 standards. Used in clinical settings; provides a physical barrier. Benefits include protection against contamination during medical examinations.

Clinical Evidence

Bench testing only. Testing included physical properties (tensile strength, elongation), pinhole detection (ASTM D5151), residual powder content (ASTM D6124), and biocompatibility (ISO 10993-10 for irritation/sensitization and ISO 10993-5 for cytotoxicity). Results confirm compliance with ASTM D6319 specifications.

Technological Characteristics

Material: Nitrile. Form factor: Disposable examination glove. Sizes: XS-XL. Thickness: 0.05-0.14mm depending on location. Standards: ASTM D6319 (specifications), ASTM D5151 (pinholes), ASTM D6124 (powder), ISO 10993-5/10 (biocompatibility). Non-sterile. No energy source or software.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands to prevent contamination between patient and examiner. No specific age or gender restrictions.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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.

March 2, 2021

Kanglongda Vietnam Protection Technology Company Limited % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District, Beijing 102401 China

Re: K202356

Trade/Device Name: Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 1, 2021 Received: February 4, 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.

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

{1}------------------------------------------------

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 (OS) 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 mediation-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, PhD 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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K202356

### Device Name

Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)

Indications for Use (Describe)

The Powder free Nitrile Examination Gloves (Blue, White, Cobalt Blue) 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)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

{3}------------------------------------------------

# 510(k) Summary

The assigned 510(k) Number: K202356

- 1. Date of Preparation: 01/29/2021
- 2. Sponsor

### KANGLONGDA Vietnam Protection Technology Company Limited

Lot CN 05, Viglacera - Phong Dien Industrial Park, Phong Hoa Commune, Phong Dien District, Thua Thien Hue Province, Vietnam 535041 Contact Person: Lu Lingfeng Position: 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: Powder free Nitrile Examination Gloves (Blue, White, Cobalt Blue) Common Name: NITRILE Patient Examination Gloves (Powder Free)

Regulatory Information: Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250

Product Name: Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) Manufacturer: KANGLONGDA Vietnam Protection Technology Company Limited

Indication For Use Statement:

{4}------------------------------------------------

The Powder free Nitrile Examination Gloves (Blue, White, Cobalt Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

- Predicate Device Identification 5.
510(k) Number: K150340 Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250

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, Powder Free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) 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 Powder Free Nitrile Examination Gloves and includes variations of different size and color. The colors of the proposed device are Blue, Violet Blue, White, and Cobalt Blue.

The proposed device is not provided as sterilized

| REF | Cuff<br>Thickness<br>( $\pm$ 0.01mm) | Palm<br>Thickness<br>( $\pm$ 0.01mm) | Finger<br>Thickness<br>( $\pm$ 0.01mm) | Length<br>(mm) | Width<br>(mm) | Color |
|------|--------------------------------------|--------------------------------------|----------------------------------------|----------------|-----------------|---------------|
| KF30 | 0.05 | 0.06 | 0.08 | $\ge$ 230 | XS:70 $\pm$ 10 | Blue / |
| KF35 | 0.06 | 0.07 | 0.09 | | S: 80 $\pm$ 10 | Violet Blue / |
| KF40 | 0.06 | 0.08 | 0.11 | | M:95 $\pm$ 10 | White / |
| KF45 | 0.07 | 0.09 | 0.12 | | L:110 $\pm$ 10 | Cobalt Blue |
| KF50 | 0.07 | 0.09 | 0.13 | | XL:120 $\pm$ 10 | |
| KF55 | 0.08 | 0.10 | 0.14 | | | |

Table 1 Device Size Specifications

Table 2 Performance and Physical Specifications

| Before Aging | | After Aging | | Pinhole AQL |
|---------------------|------------------------|---------------------|------------------------|-------------|
| Tensile<br>Strength | Ultimate<br>Elongation | Tensile<br>Strength | Ultimate<br>Elongation | 1.5 |
| 14 MPa, min | 500 % min | 14 MPa, min | 400 % min | |

{5}------------------------------------------------

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

# 7. Technological Comparison Table

| Table 1 General Comparison | | | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| ITEM | Proposed Device (K202356) | Predicate Device (K150340) | Remark |
| | Powder free Nitrile Examination Gloves<br>(Blue, Violet Blue, White, Cobalt Blue) | POWDER FREE Nitrile GLOVES (White,<br>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 (Blue, Violet Blue, White, Cobalt<br>Blue) is a disposable device intended for<br>medical purposes that is worn on the<br>examiner's hands to prevent contamination<br>between 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 |
| Powdered or<br>Powered free | Powdered free | Powdered free | SAME |

Table 1 General Comparison

{6}------------------------------------------------

| Proposed Device | | Size | | | | | |
|-----------------------------------------------------------------------------------|-------------|----------------|-----------|-----|-----|-----|------------|
| Powder free Nitrile Examination Gloves<br>(Blue, Violet Blue, White, Cobalt Blue) | Designation | XS | S | M | L | XL | Tolerance |
| | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
| | Width, mm | 70 | 80 | 95 | 110 | 120 | $\pm$ 10 |
| | | Thickness, mm: | | | | | |
| | | Finger | 0.08-0.14 | | | | $\pm$ 0.01 |
| | | Palm | 0.06-0.10 | | | | $\pm$ 0.01 |
| | | Cuff | 0.05-0.08 | | | | $\pm$ 0.01 |
| 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 | $\pm$ 10 |
| | | Thickness, mm: | | | | | |
| | | Finger | 0.10-0.12 | | | | $\pm$ 0.03 |
| | | Palm | 0.08-0.10 | | | | $\pm$ 0.03 |
| | | Cuff | 0.06-0.09 | | | | $\pm$ 0.03 |

Table 2 Device Dimensions Comparison

Table 3 Performance Comparison

| | | | Proposed Device | Predicate Device (K150340) | |
|------------------------|-----------------|------------------------|--------------------------------------------------------------------------------------|------------------------------------------------------------------------|-----------|
| ITEM | | | Powder free Nitrile Examination<br>Gloves (Blue, Violet Blue, White,<br>Cobalt Blue) | POWDER FREE Nitrile GLOVES<br>(White, Cobalt Blue, Black, Ice<br>Blue) | Remark |
| Colorant | | | Blue, Violet Blue, White, Cobalt Blue | White, Cobalt Blue, Black, Ice Blue | Different |
| Physical<br>Properties | Before<br>Aging | Tensile<br>Strength | 14 MPa, min | 15 MPa, min | Similar |
| | | Ultimate<br>Elongation | 500 % min | 500 % min | SAME |
| | | | | | |
| | After<br>Aging | Tensile<br>Strength | 14 MPa, min | 14 MPa, min | SAME |
| | | Ultimate<br>Elongation | 400 % min | 400 % min | SAME |
| | | | | | |
| | | | 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 | Meet the requirements of ASTM | SAME |

{7}------------------------------------------------

| | in accordance with ASTM D6124 | 6319 |
|--|-------------------------------|------|
|--|-------------------------------|------|

| ITEM | Proposed Device | Predicate Device (K150340) | Remark | |
|------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------|
| | Powder free Nitrile Examination<br>Gloves (Blue, Violet Blue, White,<br>Cobalt Blue) | POWDER FREE Nitrile GLOVES<br>(White, Cobalt Blue, Black, Ice<br>Blue) | | |
| Material | Nitrile | Nitrile | SAME | |
| Biocompatibility | Irritation and<br>Sensitization | Under the conditions of the study,<br>not an irritant and not a sensitizer | Under the conditions of the study,<br>not an irritant and not a sensitizer. | SAME |
| | Cytotoxicity | Under conditions of the study, not<br>cytotoxic. | N/A | Different |
| | Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | SAME |

#### Table 4 Safety Comparison

#### 8. Non-Clinical Test

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.

- 9. Conclusion
The conclusions drawn from the nonclinical test that the device is as safe, as effective, and performs as well as or better than the predicate device.