Clover Glove

K213729 · Clover Glove Company Limited · LZA · Mar 26, 2022 · General Hospital

Device Facts

• Record ID: K213729
• Device Name: Clover Glove
• Applicant: Clover Glove Company Limited
• Product Code: LZA · General Hospital
• Decision Date: Mar 26, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Clover Glove Nitrile Examination Gloves Powder Free 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

Disposable nitrile examination glove; made from acrylonitrile-butadiene copolymer dispersion; blue color; finger-textured; ambidextrous; non-sterile. Used in clinical settings by healthcare providers to provide a barrier against contamination between patient and examiner. Device functions as a physical barrier; performance verified via ASTM D6319-19 standards for dimensions, physical properties (tensile strength, elongation), and barrier integrity (AQL 2.5).

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D6319-19 for dimensions, physical properties (tensile strength >14 MPa, elongation >500% before aging), and barrier integrity (AQL 2.5). Biocompatibility testing per ISO 10993-1 included skin sensitization, skin irritation, acute systemic toxicity, and material-mediated pyrogenicity, all showing acceptable results.

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer (nitrile). Standards: ASTM D6319-19. Form factor: Ambidextrous, finger-textured, blue, powder-free. Dimensions: Length min 230mm, palm/finger thickness min 0.05mm. Sterilization: Non-sterile. Connectivity: None.

Indications for Use

Indicated for use as a disposable, non-sterile, powder-free nitrile examination glove worn on the examiner's hand to prevent contamination between patient and examiner in medical settings.

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

• Jr Medic Blue Nitrile Examination Gloves Powder Free (K192333)

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: 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 26, 2022

Clover Glove Company Limited % Manoj Zacharias US Agent Liberty Management Group Limited 75 Executive Drive, Suite 114 Aurora, Illinois 60504

Re: K213729

Trade/Device Name: Clover Glove Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: March 02, 2022 Received: March 07, 2022

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.

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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 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.

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) K213729

Device Name

Clover Glove Nitrile Examination Gloves Powder Free

### Indications for Use (Describe)

Clover Glove Nitrile Examination Gloves Powder Free 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)

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Image /page/3/Picture/0 description: The image shows the logo for Clover Glove. The logo consists of a four-leaf clover on the left, with the top two leaves being green and the bottom left leaf being red. The bottom right leaf is also green. To the right of the clover is the word "CLOVER" in gray, with the "V" in red. Below the word "CLOVER" is a horizontal line, and below that is the word "GLOVE" in gray, with the "G" in orange.

# 510(k) SUMMARY (K213729)

[AS REQUIRED BY 21CFR807.92]

#### I. SUBMITTER

| 510(k) Owner's Name | Clover Glove Company Limited |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 1999/8 District Sriwara Village, Ladphrao 94 (Punjamit),<br>Sriwara Rd, Plabphla, Wang Thong Lang, Krung Thep Maha<br>Nakhon, Thailand 10240 |
| Telephone | [phone] |
| Contact person | Mr.Pongsin Pongwachirint |
| Designation | Managing Director |
| Contact Email | [e-mail] |
| Date of Summary Prepared | 25.03.2022 |

#### II. DEVICE

| Device Trade Name | Clover Glove |
|----------------------------|----------------------------------------|
| Device Common Name | Nitrile Examination Gloves Powder Free |
| Device Classification name | Non-powdered patient examination glove |
| Regulation Number | 21 CFR 880.6250 |
| Class | I |
| Product Code | LZA |

# III. PREDICATE DEVICE

| Predicate Device Name | Jr Medic Blue Nitrile Examination Gloves Powder Free |
|-----------------------|------------------------------------------------------|
| 510(k) Number | K192333 |
| Regulation Number | 21 CFR 880.6250 |
| Class | I |
| Product Code | LZA |

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Image /page/4/Picture/0 description: The image shows the logo for Clover Glove. The logo consists of a four-leaf clover on the left, with the top two leaves being green and the bottom left leaf being red. The bottom right leaf is also green. To the right of the clover is the word "CLOVER" in gray letters, except for the "V" which is red. Below the word "CLOVER" is a green line, and below that is the word "GLOVE" in gray letters, except for the "G" which is orange.

## IV. DEVICE DESCRIPTION

Clover Glove Nitrile Examination Gloves Powder Free is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.

#### V. INDICATIONS OF USE

Clover Glove Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose 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 | K213729 | K192333 | - | |
| 2. | Manufacturer | Clover Glove Company Limited | JR Engineering & Medical<br>Technologies (M) SDN.BHD | - | |
| 3. | Classification | I | I | Same | |
| 4. | Regulation number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | |
| 5. | Product Code | LZA | LZA | Same | |
| 6. | Indication For Use | Clover Glove Nitrile Examination<br>Gloves Powder Free is a disposable<br>device intended for medical<br>purpose that is worn on the<br>examiner's hand to prevent<br>contamination between patient<br>and examiner. | Jr Medic Blue Nitrile Examination<br>Gloves Powder Free 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 | Data not available | - | |
| 11. | Size | S, M, L | XS, S, M, L, XL | Similar | |
| 12. | OTC Use | Yes | Yes | Same | |
| SI.<br>No | Features compared | Proposed Device | Predicate Device | Result | |
| 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<br>Mm (for medium size) | Length Min 230 mm<br>Width Min 95±10<br>Mm (for medium size) | Same | |
| 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 1.5 | Similar | |
| 19. | Powder Free Residue | ≤2 mg/glove Max | ≤2 mg/glove Max | Same | |
| 20. | Shelf Life | 3 Years | Data Not Available | - | |
| 21. | Biocompatibility Study | In Vitro Cytotoxicity | Under the conditions of the study,<br>cytotoxic. Additional testing was<br>performed to determine if this was<br>a systemic toxicity concern. | Under the conditions of the study,<br>cytotoxic. Additional testing was<br>performed to determine if this<br>was a systemic toxicity concern. | Same |
| | | Skin Sensitization | Under the condition of the study<br>not a sensitizer | Under the condition of the study<br>not a sensitizer | Same |
| | | Skin Irritation | Under the condition of the study<br>not an irritant | Under the condition of the study<br>not an irritant | Same |
| | | Acute Systemic<br>Toxicity | Under the conditions of study, the<br>device extracts do not pose a<br>systemic toxicity concern | Under the conditions of study, the<br>device extracts do not pose a<br>systemic toxicity concern | Same |
| | | Material Mediated<br>Pyrogenicity | Under the conditions of the study, the<br>device did not demonstrate a<br>material mediated pyrogenicity<br>response. | Under the conditions of the<br>study, the device did not<br>demonstrate a material mediated<br>pyrogenicity response. | Same |

### Table 1: General Comparison

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Image /page/5/Picture/0 description: The image shows the logo for Clover Glove. The logo consists of a four-leaf clover on the left and the words "CLOVER GLOVE" on the right. The clover has two green leaves, one red leaf, and one yellow leaf. The words "CLOVER GLOVE" are in gray, with the "V" in "CLOVER" being red and the "G" in "GLOVE" being yellow. A green line separates the two words.

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Image /page/6/Picture/0 description: The image is a logo for Clover Glove. The logo consists of a four-leaf clover on the left and the words "CLOVER GLOVE" on the right. The clover is made up of four circles, with the top left circle being red, the top right and bottom left circles being green, and the bottom right circle being orange. The word "CLOVER" is in gray, except for the letter "V", which is red. The word "GLOVE" is in gray, except for the letter "G", which is orange.

#### PERFORMANCE DATA VII.

#### A. Non- Clinical Data

### Performance Tests

Clover Glove Nitrile Examination Gloves Powder Free is subjected to the following performance tests according to the requirements of Guidance for Industry and FDA Staff - Medical Glove Guidance Manual and found to be safe and efficient with respect to its intended use:

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

| SI<br>No. | Tests | Proposed Device<br>Actual Data | | | Acceptance Criteria | | | Result |
|-----------|------------------------------------------------------------------------------------------------------|--------------------------------|---------------------|----------------|---------------------|---------------------|----------------|--------|
| 1. | | Size | Length | Width | Size | Length | Width | |
| | Dimension<br>Length, Width and<br>Thickness | S | 245.15mm | 83mm | S | | 80mm±10 | Pass |
| | | M | 247.1 mm | 92.69 mm | M | 230mm Min | 95mm ±10 | |
| | | L | 248.30mm | 108.07mm | L | | 110mm ±10 | |
| | ASTM D6319-19 | Thickness | | | Thickness | | | |
| | Standard Specification for<br>Nitrile Examination Gloves<br>for Medical Application | Size | Palm | Finger | Size | Palm | Finger | |
| | | S | 0.08 mm | 0.123mm | S | 0.05 mm | 0.05 mm | Pass |
| | | M | 0.09 mm | 0.138mm | M | Min | Min | |
| | | L | 0.09 mm | 0.14mm | L | | | |
| 2. | | | Tensile strength | | Tensile strength | | | |
| | Physical property<br>Tensile strength and<br>Ultimate Elongation | Size | Before<br>Aging | After<br>Aging | Size | Before<br>Aging | After<br>Aging | |
| | | S | 30.60 MPa | 30.66 MPa | S | 14 MPa | 14 MPa | Pass |
| | | M | 31.72 MPa | 30.80 MPa | M | Min | Min | |
| | | L | 37.01 MPa | 35.46 MPa | L | | | |
| | ASTM D6319-19<br>Standard Specification for<br>Nitrile Examination Gloves<br>for Medical Application | | Ultimate Elongation | | | Ultimate Elongation | | |
| | | Size | Before<br>Aging | After<br>Aging | Size | Before<br>Aging | After<br>Aging | |
| | | S | 604.61% | 573.84% | S | 500% | 400% | |
| | | M | 575.38% | 580% | M | Min | Min | |
| | | L | 596.92% | 566.15% | L | | | |

### Table 2: Performance Testing Summary

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Image /page/7/Picture/0 description: The image shows the logo for Clover Glove. The logo has a four-leaf clover on the left side, with the top two leaves being green and the bottom left leaf being red and the bottom right leaf being green. To the right of the clover is the word "CLOVER" in gray, with the "V" in red. Below the word "CLOVER" is a green line, and below that is the word "GLOVE" in gray, with the "G" in orange.

| SI<br>No. | Tests | Proposed Device<br>Actual Data | | Acceptance Criteria | | Result |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|-------------------------|-----------------------|-------------------------|--------|
| 3. | Barrier property tests<br>Detection of Holes in<br>Medical Gloves<br>ASTM D6319-19<br>ASTM D5151-19<br>Standard Test Method for<br>Detection of Holes in Medical<br>Gloves | AQL 2.5 for all sizes | | AQL 2.5 for all sizes | | Pass |
| 4. | Powder Free Residue | Size | Residual powder content | Size | Residual powder content | |
| | ASTM D6124-06<br>(Reapproved 2017) | S | 0.42mg | S | | Pass |
| | Standard Test Method for | M | 0.34mg | M | ≤2Mg/ Glove Max | |
| | Residual Powder on Medical<br>Gloves | L | 0.20mg | L | | |

#### Biocompatibility B.

The materials used in the Clover Glove Nitrile Examination Gloves Powder Free are biocompatible based on the biocompatibility tests mentioned in the Guidance for Industry and FDA Staff - Medical Glove Guidance Manual:

- In Vitro Cytotoxicity
- Skin Sensitization
- Skin Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity

These tests were performed according to ISO 10993-1:2018, Biological Evaluation of Medical Devices -Part 1, Evaluation and Testing within a Risk Management Process.

| | Table 3: Biocompatibility Test Summary | |
|--|----------------------------------------|--|
|--|----------------------------------------|--|

| SI.<br>No | Test Performed | Proposed Device | Acceptance Criteria | Result |
|-----------|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-----------|
| 1. | In Vitro Cytotoxicity | Under the conditions of the study,<br>cytotoxic.<br>Additional<br>testing<br>was<br>performed to determine if this was a<br>systemic toxicity concern. | Under the conditions of the<br>study, non-cytotoxic. | Different |
| 2. | Skin Sensitization | Under the conditions of the study not<br>a sensitizer | Under the conditions of the<br>study not a sensitizer | Pass |
| 3. | Skin Irritation | Under the condition of study not an<br>irritant | Under the condition of study<br>not an irritant | Pass |

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Image /page/8/Picture/0 description: The image shows the logo for Clover Glove. The logo has a four-leaf clover on the left side, with the top two leaves being green and the bottom left leaf being red. The bottom right leaf is also green. To the right of the clover is the word "CLOVER" in gray letters, except for the "V" which is red. Below the word "CLOVER" is a green line, and below that is the word "GLOVE" in gray letters, except for the "G" which is yellow.

| 4. | Acute Systemic Toxicity | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Pass |
|----|--------------------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------|
| 5. | Material<br>Mediated<br>Pyrogenicity | Under the condition of the study, The device did not demonstrate a Material mediated pyrogenicity response | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. | Pass |

- * Since the cytotoxic study showing positive cytotoxic response, additional testing for acute systemic toxicity is conducted to determine if this was a systemic toxicity concern and it showed that the subject glove did not induce systemic toxicity in the test animals, which demonstrated that the cytotoxicity reactivity observed is not a significant concern in clinical settings.
#### C. Clinical Test Data

Clinical study was not conducted as clinical data is not needed for Clover Glove Nitrile Examination Gloves Powder Free.

### VIII. CONCLUSION

The conclusion drawn from the non-clinical tests demonstrate that the subject device in 510(k) submission, Clover Glove Nitrile Examination Gloves Powder free is as effective, and performs as well as or better than the legally marketed predicate device, K192333.