Nitrile Examination Gloves

K222813 · Ecoglove Medical Manufacturing Company Limited · LZA · Mar 16, 2023 · General Hospital

Device Facts

• Record ID: K222813
• Device Name: Nitrile Examination Gloves
• Applicant: Ecoglove Medical Manufacturing Company Limited
• Product Code: LZA · General Hospital
• Decision Date: Mar 16, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Nitrile Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Nitrile Examination Gloves are disposable, non-sterile, ambidextrous, blue nitrile gloves with finger texture. Used by healthcare examiners to prevent cross-contamination between patient and examiner. Device acts as a physical barrier. No electronic, software, or algorithmic components. Used in clinical settings; no special training required for operation.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing including dimensions, physical properties (tensile strength, elongation), barrier properties (AQL 2.5), powder-free residue, and biocompatibility (sensitization, irritation, acute systemic toxicity).

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer (nitrile). Form factor: Ambidextrous, finger-textured, powder-free. Standards: ASTM D6319-19 (dimensions, physical properties), ASTM D5151-19 (barrier), ASTM D6124-06 (residue). Biocompatibility: ISO 10993-5, 10, 11, 23. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-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

• ATM® Glove Powder free Nitrile Examination gloves (K213016)

Submission Summary (Full Text)

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

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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

March 16, 2023

Ecoglove Medical Manufacturing Company Limited % Manoj Zacharias US Agent Liberty Management Group Limited 75 Executive Drive Suite 114 Aurora, Illinois 60504

Re: K222813

Trade/Device Name: Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 13, 2023 Received: February 22, 2023

Dear Manoj Zacharias:

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

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

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,

# Allan Gu

For Bifeng Qian, M.D., Ph.D. 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}------------------------------------------------

# Indications for Use

510(k) Number (if known) K22813

Device Name

Nitrile Examination Gloves

Indications for Use (Describe)

Nitrile Examination Gloves is a disposable device intended for medical purpose 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)

### 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 PRAStaff(@fda.hhs.gov

"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."

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

# 510(k) SUMMARY (K222813)

[AS REQUIRED BY 21CFR807.92]

#### SUBMITTER DETAILS I.

| 510(k) Owner's Name | : | ECOGLOVE MEDICAL MANUFACTURING COMPANY LIMITED |
|---------------------------------------------------------|---|-------------------------------------------------------------------------------------------------------------------------------------|
| Address | : | A part of land plot No. 679, map No. 41, N4 Street, Bau Bang Hamlet, Lai Uyen Town, Bau Bang District, Binh Duong Province, Vietnam |
| Telephone | : | 02743599000 |
| Contact person | : | NGUYEN ANH TU |
| Designation | : | President |
| Contact Email | : | [e-mail] |
| Correspondent Contact Details<br>(US Agent Information) | : | Mr. Manoj Zacharias,<br>Liberty Management Group Limited,<br>75 Executive Drive Suite 114, Aurora, Illinois, 60504, US |
| | | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date of Summary Prepared | : | 03-15-2023 |

## II. DEVICE DETAILS

| Device Name | : | Nitrile Examination Gloves |
|----------------------------|---|----------------------------------------|
| Device Classification Name | : | Non-powdered patient examination glove |
| Regulation Number | : | 21 CFR 880.6250 |
| Class | : | I |
| Product Code | : | LZA |

## III. PREDICATE DEVICE DETAILS

| Predicate Device Name | : ATM® Glove Powder free Nitrile Examination gloves |
|-----------------------|-----------------------------------------------------|
| 510(k) Number | : K213016 |
| Regulation Number | : 21 CFR 880.6250 |
| Class | : I |
| Product Code | : LZA |

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

## IV. DEVICE DESCRIPTION

Nitrile Examination Gloves is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color have Finger Texture, Ambidextrous, single-use, and are powderfree. The product is non-sterile.

#### V. INDICATIONS FOR USE

Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| SI.<br>No | Features compared | Proposed Device | Predicate Device | Result |
|---------------------|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| General Information | | | | |
| 1. | 510(k) Number | K222813 | K213016 | - |
| 2. | Manufacturer | ECOGLOVE Medical Manufacturing<br>Company Limited | PHU DUC HUY Production Trading<br>Services Corporation | - |
| 3. | Classification | I | I | - |
| 4. | Regulation number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| 5. | Product Code | LZA | LZA | Same |
| 6. | Indication For Use | Nitrile Examination Gloves is a<br>disposable device intended for<br>medical purpose that is worn on<br>the examiner's hand to prevent<br>contamination between patient<br>and examiner. | ATM® Glove Powder free Nitrile<br>Examination gloves are intended<br>for medical purposes that is worn<br>on the examiner's hands to<br>prevent contamination between<br>patient and examiner. | Same |
| 7. | Material | Nitrile | Nitrile | Same |
| 8. | Color | Blue | Blue | Same |
| 9. | Texture | Finger Texture | Finger texture | Same |
| 10. | Ambidextrous | Yes | Yes | Same |
| 11. | Size | S, M, L, XL | S, M, L, XL | Same |
| 12. | OTC Use | Yes | Yes | Same |
| 13. | Reusability | Single use | Single use | Same |
| 14. | Sterility | Non- sterile | Non- sterile | Same |
| 15. | Dimensions | Length Min 230 mm<br>Width Min 95±10 mm (for<br>medium size) | Length Min 230 mm<br>Width Min 95±10 mm (for<br>medium size) | Same |

## Table 1: General Comparison

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

| Sl.<br>No | Features compared | Proposed Device | Predicate Device | Result | |
|-----------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------|
| 16. | Thickness | Palm min 0.05 mm<br>Finger min 0.05 mm | Palm min 0.05 mm<br>Finger min 0.05 mm | Same | |
| 17. | Physical Properties | Before Aging<br>Tensile Strength min 14 MPa<br>Ultimate Elongation Min 500%<br>After Aging<br>Tensile Strength min 14 MPa<br>Ultimate Elongation Min 400% | Before Aging<br>Tensile Strength min 14 MPa<br>Ultimate Elongation Min 500%<br>After Aging<br>Tensile Strength min 14 MPa<br>Ultimate Elongation Min 400% | Same | |
| 18. | Detection of Holes | Passes AQL 2.5 | Passes AQL 2.5 | Same | |
| 19. | Powder Free Residue | ≤2 mg/glove | ≤2 mg/glove | Same | |
| 20. | Biocompatibility Study | In vitro Cytotoxicity | Under the conditions of the study, cytotoxic. | Under the conditions of the study non- cytotoxic to L-929 cells. | Different<br>Refer Note1 |
| | | Skin Sensitization | Under the condition of the study not a sensitizer | Under the condition of the study not a sensitizer | Same |
| | | Skin Irritation | Under the condition of the study not an irritant | Under the condition of the study not an irritant | Same |
| | | Acute systemic toxicity | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the conditions of the study, the device extracts do not pose a systemic toxicity concern | Same |

| | | | Note1: Additional testing was performed to determine if this was a systemic toxicity concern. | |
|--|--|--|-----------------------------------------------------------------------------------------------|--|
|--|--|--|-----------------------------------------------------------------------------------------------|--|

There are no significant differences between the two products and are similar in terms of intended use, materials, design, and manufacturing methods. Both devices met the performance standards.

# VII. PERFORMANCE DATA

#### A. Non-Clinical Data

#### Performance Tests ਜ

Nitrile Examination Gloves are subjected to the following performance tests according to the requirements of Guidance for Industry and FDA Staff - Medical Glove Guidance Manual

- . Dimension.
- Physical property .
- . Barrier property tests
- > Detection of Holes in Medical Gloves
- . Powder-Free Residue

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

| SI<br>No. | Tests | Proposed Device actual Data | | | Acceptance Criteria | | |
|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------------|-------------|---------------------|-----------------------------|-----------------------------|
| | | Size | Length | Width | Size | Length | Width |
| 1. | Dimension<br>Length, Width and<br>Thickness<br>ASTM D6319-19<br>Standard<br>Specification for<br>Nitrile Examination<br>Gloves for Medical<br>Application | S | 243 mm | 84.92 mm | S | 220mm min | 80 mm±10 |
| | | M | 242.30 mm | 95.30 mm | M | | 95 mm ±10 |
| | | L | 243.30 mm | 110.53 mm | L | 230mm min | 110 mm ±10 |
| | | XL | 243.07 mm | 120.62 mm | XL | | 120 mm ±10 |
| | | Thickness | | | Thickness | | |
| | | Size | Palm | Finger | Size | Palm | Finger |
| | | S | 0.086 mm | 0.115 mm | S | | |
| | | M | 0.086 mm | 0.110 mm | M | 0.05 mm min | 0.05 mm min |
| | | L | 0.085 mm | 0.115 mm | L | | |
| | | XL | 0.085 mm | 0.115 mm | XL | | |
| | | Tensile strength | | | Tensile strength | | |
| | | Size | Before aging | After aging | Size | Before aging | After aging |
| 2. | Physical property<br>Tensile strength<br>and Ultimate<br>Elongation<br>ASTM D6319-19<br>Standard<br>Specification for<br>Nitrile Examination<br>Gloves for Medical<br>Application | S | 17.44 MPa | 16.52 MPa | S | | |
| | | M | 17.60 MPa | 16.79 MPa | M | 14 MPa Min for all<br>sizes | 14 MPa Min for all<br>sizes |
| | | L | 16.75 MPa | 15.48 MPa | L | | |
| | | XL | 16.03 MPa | 15.07 MPa | XL | | |
| | | Ultimate elongation | | | Ultimate elongation | | |
| | | Size | Before aging | After aging | Size | Before aging | After aging |
| | | S | 519% | 511% | S | | |
| | | M | 521% | 511% | M | 500% Min for all<br>sizes | 400%Min for all<br>sizes |
| | | L | 565% | 510% | L | | |
| | | XL | 550% | 514% | XL | | |
| 3. | Detection of Holes<br>in Medical Gloves<br>ASTM D6319-19<br>/ASTM D5151-19<br>Standard Test<br>Method for<br>Detection of Holes<br>in Medical Gloves | Size | AQL 2.5 | | Size | AQL 2.5 | |
| | | S | | | S | | |
| | | M | | | M | | |
| | | L | | | L | | |
| | | XL | | | XL | | |
| 4. | Powder-Free<br>Residue<br>ASTM D6124-06<br>(Reapproved 2017)<br>Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves | Size | Residual powder content | | Size | Residual powder content | |
| | | S | 0.02 Mg/glove | | S | | |
| | | M | 0.01 Mg/glove | | M | ≤ 2 mg/Glove Max | |
| | | L | 0.01 Mg/glove | | L | | |
| | | XL | 0.01 Mg/glove | | XL | | |

## Table 2: Performance Testing Summary

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

#### 2 Biocompatibility Tests

The Biocompatibility Tests performed are:

- . In vitro Cytotoxicity
- . Skin Sensitization
- Skin Irritation ●
- Acute Systemic Toxicity ●

## Table 3: Biocompatibility Test Summary

| SL<br>no | Title of Test | Purpose of<br>Test | Reference<br>Source | Acceptance<br>Criteria | Result |
|----------|-------------------------|---------------------------------------------|---------------------|------------------------|--------|
| 1 | In Vitro Cytotoxicity | To ensure the<br>device is<br>biocompatible | ISO 10993-5:2009 | Non-cytotoxic | Fail |
| 2 | Skin Sensitization | | ISO 10993-10:2021 | Non-sensitizer | Pass |
| 3 | Skin Irritation | | ISO 10993-23:2021 | Non-irritant | Pass |
| 4 | Acute Systemic Toxicity | | ISO 10993-11:2017 | Nontoxic | Pass |

#### 3 Sterilization

A sterilization study was not conducted as Nitrile Examination Gloves is provided non-sterile.

#### C Clinical Test Data

The clinical study was not conducted as clinical data is not needed for Nitrile Examination Gloves.

## VII. CONCLUSION

The conclusions drawn from the non-clinical tests demonstrate that the subject device, Nitrile Examination Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicate device in K213016.