AT

K212645 · At Glove Engineering Sdn. Bhd · LZA · Dec 16, 2021 · General Hospital

Device Facts

• Record ID: K212645
• Device Name: AT
• Applicant: At Glove Engineering Sdn. Bhd
• Product Code: LZA · General Hospital
• Decision Date: Dec 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

AT Nitrile Examination Glove 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; violet blue color; finger-textured; ambidextrous; non-sterile. Worn by healthcare examiners to provide a barrier against contamination between patient and examiner. Device meets ASTM D6319-19 standards for physical properties, dimensions, and barrier integrity. Used in clinical or medical environments. Benefits include protection against cross-contamination during patient examinations.

Clinical Evidence

No clinical data was conducted. Evidence is based on non-clinical bench testing, including physical properties (tensile strength, elongation), barrier integrity (AQL 2.5), residual powder content, and biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogenicity) per ISO 10993 and ASTM standards.

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer. Form: Ambidextrous, finger-textured, powder-free. Dimensions: Length min 230mm, palm/finger thickness min 0.05mm. Standards: ASTM D6319-19 (physical/dimensional), ASTM D5151-19 (barrier), ASTM D6124-06 (powder residue), ISO 10993 (biocompatibility). Non-sterile.

Indications for Use

Indicated for use as a disposable, ambidextrous, 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

• Disposable Nitrile Gloves (K210276)

Submission Summary (Full Text)

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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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bold blue font. Below that is the word "ADMINISTRATION" in a smaller, lighter blue font.

December 16, 2021

AT Glove Engineering SDN. BHD Manoj Zacharias US Agent Liberty Management Group Limited 75 Executive Drive Suite 114 Aurora, Illinois 60504

Re: K212645

Trade/Device Name: At Nitrile Examination Glove Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 15, 2021 Received: November 17, 2021

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.

For Clarence W. Murray, III, 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K212645

Device Name

AT Nitrile Examination Glove Powder Free

### Indications for Use (Describe)

AT Nitrile Examination Glove 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) | <table border="0"><tr><td><input disabled="disabled" type="checkbox"/> Registration Use (Part 21 CFR 201 Subpart D) </td><td><input checked="checked" disabled="disabled" type="checkbox"/> Over-The-Counter Use (21 CFR 201 Subpart C) </td></tr></table> | <input disabled="disabled" type="checkbox"/> Registration Use (Part 21 CFR 201 Subpart D) | <input checked="checked" disabled="disabled" type="checkbox"/> Over-The-Counter Use (21 CFR 201 Subpart C) |
|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| <input disabled="disabled" type="checkbox"/> Registration Use (Part 21 CFR 201 Subpart D) | <input checked="checked" disabled="disabled" type="checkbox"/> Over-The-Counter Use (21 CFR 201 Subpart C) | | |

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

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1// AT GLOVE ENGINEERING SDN. BHD. 202001014272 (1370592-K)

Image /page/3/Picture/1 description: The image shows a logo with the letters 'AI' in a stylized font. The 'A' is red and appears to be leaning slightly to the right, while the 'I' is black and stands upright. The logo has a modern and bold design.

No. 9, Jalan Chepor 11/7, Kawasan Perusahaan Seramik Chepor, 31200, Chemor, Perak, Malaysia Tel : [phone] URL : www.atsys.com.my

# 510(k) SUMMARY (K212645)

[AS REQUIRED BY 21CFR807.92]

### I. SUBMITTER DETAILS

| 510(k) Owner's Name | : | AT GLOVE ENGINEERING SDN. BHD |
|--------------------------|---|----------------------------------------------------------------------------------------------|
| Address | : | No.9, Jalan Chepor 11/7, Kawasan Perusahaan Seramik<br>Chepor, 31200, Chemor Perak, Malaysia |
| Telephone | : | [phone] |
| Fax Number | : | [phone] |
| Contact person | : | Mr. Choong Lee Aun |
| Designation | : | Managing Director |
| Contact Number | : | 00 60 124055026 |
| Contact Email | : | [e-mail] |
| Date of Summary Prepared | : | December 6, 2021 |

### II. DEVICE DETAILS

| Device Trade Name | : AT |
|----------------------------|------------------------------------------|
| Device Common Name | : Nitrile Examination Glove Powder Free |
| 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 | : Disposable Nitrile Gloves |
|-----------------------|-----------------------------|
| 510(k) Number | : K210276 |
| Regulation Number | : 880.6250 |
| Class | : I |
| Product Code | : LZA |

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Image /page/4/Picture/0 description: The image shows a logo with the letters 'AT' in a stylized design. The 'A' is colored in a gradient from red to black, and the 'T' is black with three white lines on the right side. The logo has a modern and sleek appearance.

## IV. DEVICE DESCRIPTION

AT Nitrile Examination Glove 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 Violet blue in color having Finger Texture and Ambidextrous and are powder free. The product is non-sterile.

#### INDICATIONS FOR USE V.

AT Nitrile Examination Glove 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.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE

| SI.<br>No | Features compared | Proposed Device | Predicate Device | Result | | | | | |
|-----------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|--|--|--|--|--|
| | General Information | | | | | | | | |
| 1. | 510(k) Number | K212645 | K210276 | - | | | | | |
| 2. | Manufacturer | AT GLOVE ENGINEERING SDN.<br>BHD | FUJIAN ERCON MEDICAL<br>MANAGEMENT CO., LTD. | - | | | | | |
| 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 | AT<br>Nitrile<br>Examination<br>Glove<br>Powder Free is a disposable device<br>intended for medical purpose that<br>is worn on the examiner's hand to<br>prevent contamination<br>between<br>patient and examiner. | The Disposable Nitrile Gloves are<br>intended for medical purposes<br>that is worn on the examiner's<br>hands to prevent contamination<br>between patient and examiner. | Same | | | | | |
| 7. | Material | Nitrile | Nitrile | Same | | | | | |
| 8. | Color | Violet Blue | Blue | Different | | | | | |
| 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 | | | | | |

### Table 1: General Comparison

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Image /page/5/Picture/0 description: The image shows a logo with the letters 'AT' in a stylized design. The 'A' is larger and shaded from red to black, while the 'T' is black with three vertical lines to the right. The overall design is modern and suggests a company or organization with the initials 'AT'.

| SI.<br>No | Features compared | Proposed Device | Predicate Device | Result | |
|-----------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-----------|
| 14. | Sterility | Non- sterile | Non- sterile | Same | |
| 15. | Dimensions | Length Min 230 m<br>Width Min 95±10<br>Mm (for medium size) | Length Min 230 m<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 2.5 | Same | |
| 19. | Powder Free Residue | ≤2 mg/glove | ≤2 mg/glove | Same | |
| 20. | Biocompatibility Study | In Vitro<br>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<br>study, non-cytotoxic. | Same |
| | | Skin Sensitization | Under the conditions of the study<br>not a sensitizer | Under the conditions of the study<br>not a sensitizer | Same |
| | | Skin Irritation | Under the condition of study not<br>an irritant | Under the condition of study not<br>an irritant | Same |
| | | Acute Systemic<br>Toxicity | Under the condition of study, the<br>device extracts do not pose a<br>systemic toxicity. | Data not available | Different |
| | | Material Mediated<br>Pyrogenicity | Under the conditions of the study,<br>the device demonstrate a non-<br>pyrogenic response. | Data not available | Different |

# DISCUSSION OF DIFFERENCES:

Different: The color of the proposed device is violet blue whereas predicate device is blue. The color variation of the proposed device and predicate devices doesn't affect the safety and efficiency of the device.

The Performance Tests and Biocompatibility Tests demonstrated that AT Nitrile Examination Glove Powder Free met all acceptance criteria and has the similar indications for use, design, materials, technical characteristics and performance properties as compared to the predicate device. No new safety or effectiveness issues were raised during the testing program and therefore, this device may be considered substantially equivalent to the predicate device.

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Image /page/6/Picture/0 description: The image shows a logo with the letters 'AT' in a stylized design. The 'A' is colored with a gradient from red to black, and it has an arched shape. The 'T' is black and has three diagonal lines at the top right. The logo has a modern and corporate feel.

### PERFORMANCE DATA VII.

#### A. Non- Clinical Data

## Performance Tests

AT Nitrile Examination Glove 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

## Table 2: Performance Testing Summary

| | Tests | Proposed Device<br>Actual Data | | Acceptance Criteria | | Result | | |
|----|------------------------------------------------------------------------------------------------------|--------------------------------|-----------------|---------------------|---------------------|-----------------|----------------|-------|
| | | Size | Length | Width | Size | | Length | Width |
| 1. | Dimension<br>Length, Width and Thickness | S | 247.76 mm | 84.84 mm | S | 230 mm | 80±10 mm | |
| | | M | 249.53 mm | 94.46 mm | M | | 95±10 mm | |
| | | L | 253.46 mm | 105 mm | L | | 110±10 mm | |
| | | XL | 243.53 mm | 113.15 mm | XL | | 120±10 mm | |
| | | | | | | | | |
| | ASTM D6319-19<br>Standard Specification for<br>Nitrile Examination Gloves for<br>Medical Application | Thickness | | | Thickness | | | |
| | | Size | Palm | Finger | Size | Palm | Finger | |
| | | S | 0.06 mm | 0.09 mm | S | | | |
| | | M | 0.06 mm | 0.09 mm | M | 0.05 mm | 0.05 mm | |
| | | L | 0.07 mm | 0.10 mm | L | | | |
| | | XL | 0.06 mm | 0.09 mm | XL | | | |
| | | Tensile Strength | | | Tensile Strength | | | |
| | | Size | Before<br>Aging | After<br>Aging | Size | Before<br>Aging | After<br>Aging | |
| 2. | Physical property<br>Tensile strength and<br>Ultimate Elongation | S | 31.57 MPa | 29.38 MPa | S | | | |
| | | M | 27.33 MPa | 29.92 MPa | M | 14 MPa | 14 MPa | |
| | | L | 30.58 MPa | 29.91 MPa | L | | | |
| | | XL | 28.06 MPa | 30.40 MPa | XL | | | |
| | | | | | | | | |
| | ASTM D6319-19<br>Standard Specification for<br>Nitrile Examination Gloves for<br>Medical Application | Ultimate Elongation | | | Ultimate Elongation | | | |
| | | Size | Before<br>Aging | After<br>aging | Size | Before<br>Aging | After<br>aging | |
| | | S | 534.61% | 544.61% | S | | | |
| | | M | 561.53% | 550.76% | M | | | |
| | | L | 521.53% | 499.23% | L | 500% | 400% | |
| | | XL | 546.15% | 517.69% | XL | | | |

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Image /page/7/Picture/0 description: The image shows a logo with the letters 'AT' in a stylized design. The 'A' is in red and transitions to black, forming an arch shape. The 'T' is in black and has three diagonal lines above it on the right side. The logo has a modern and corporate feel.

| Barrier property tests<br>Detection of Holes in<br>Medical Gloves | S<br>M | | S<br>M | | |
|-------------------------------------------------------------------------------------------------------------------------------------|--------|-------------------------|--------|-------------------------|------|
| 3.<br>ASTM D6319-19 /ASTM D5151-<br>19<br>Standard Test Method for<br>Detection of Holes in Medical<br>Gloves | | AQL 2.5 | | AQL 2.5 | Pass |
| | XL | | XL | | |
| | Size | Residual Powder Content | Size | Residual Powder Content | |
| 4.<br>Powder Free Residue<br>ASTM D6124-06<br>(Reapproved 2017)<br>Standard Test Method for<br>Residual Powder on Medical<br>Gloves | S | 0.22 mg/glove | S | | |
| | M | 0.36 mg/glove | M | ≤2 Mg/glove | Pass |
| | L | 0.10 mg/glove | L | | |

### B. Biocompatibility

The materials used in the AT Nitrile Examination Glove 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.

| SI.<br>No | Test Performed | Standard | Proposed Device | Result |
|-----------|--------------------------------------|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| 1. | In Vitro Cytotoxicity | ISO 10993-5:2009 | Under<br>the conditions of the<br>study, cytotoxic. Additional Testing<br>was performed to determine if this<br>was a systemic toxicity concern. | Pass |
| 2. | Skin Sensitization | ISO 10993-10:2010 | Under the conditions of the study not a<br>sensitizer | Pass |
| 3. | Skin Irritation | ISO 10993-10:2010 | Under the condition of study not an<br>irritant. | Pass |
| 4. | Acute systemic Toxicity | ISO 10993-11:2017 | Under the condition of study, the<br>device extracts do not pose a systemic<br>toxicity concern | Pass |
| 5. | Material<br>Mediated<br>Pyrogenicity | ISO 10993-11:2017 | Under the conditions of the study, the<br>device demonstrate a non-pyrogenic<br>response. | Pass |

## Table 3: Biocompatibility Test Summary

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Image /page/8/Picture/0 description: The image shows a logo with the letters 'AT' in a stylized design. The 'A' is represented by a red arc that fades from dark to light, while the 'T' is in black with three vertical lines on the right side. The logo has a modern and corporate feel.

### C. Clinical Test Data

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

# VIII. CONCLUSION

The conclusion drawn from the non-clinical tests demonstrate that the subject device, AT Nitrile Examination Glove Powder Free are as safe, as effective and perform as well as or better than legally marketed predicated device in K210276