Violet Nitrile Powder Free Patient Examination Glove, Non Sterile

K210587 · Onetexx Sdn Bhd · LZA · Jun 28, 2021 · General Hospital

Device Facts

• Record ID: K210587
• Device Name: Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
• Applicant: Onetexx Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Jun 28, 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 made of Nitrile latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable patient examination glove; manufactured from nitrile latex; ambidextrous design; non-sterile. Inner surface treated for smooth donning without powder lubricants. Used in clinical settings by healthcare professionals to provide a protective barrier between examiner and patient. Prevents contamination during medical examinations. Device is single-use.

Clinical Evidence

No clinical data. Bench testing only, including physical properties (ASTM D412), dimensions (ASTM D3767), watertightness (ASTM D5151), and residual powder (ASTM D6124). Biocompatibility testing performed per ISO 10993-10 and ISO 10993-11.

Technological Characteristics

Material: Nitrile latex. Form factor: Ambidextrous, powder-free, non-sterile. Standards: ASTM D6319 (physical properties/dimensions), ASTM D5151 (watertightness), ASTM D6124 (residual powder). Biocompatibility: ISO 10993-10 (irritation/sensitization), ISO 10993-11 (acute systemic toxicity).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger 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

• Non-Sterile, Powder Free Nitrile Examination Gloves - Violet Color -LZA (K143289)

Submission Summary (Full Text)

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June 28, 2021

Onetexx SDN BHD % Michael Van der Woude U.S. Agent Emergo Global Representation 2500 Bee Cave Road, Building 1 Suite 300 Austin, Texas 78746

Re: K210587

Trade/Device Name: Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: May 23, 2021 Received: June 1, 2021

Dear Michael Van der Woude:

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

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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,

Ryan Ortega 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) K210587

Device Name VIOLET NITRILE POWDER FREE PATIENT EXAMINATION GLOVE, NON STERILE

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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Image /page/3/Picture/0 description: The image shows the word "onetexx" in a sans-serif font, with the letters in dark blue. To the right of the word is a circular logo in teal and dark blue. The logo is a circle with a square cut out of the upper right quadrant.

#### 1.0 Submitter:

| Name: | Freddy Low |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Onetexx Sdn Bhd<br>No: 73-86, Jalan Logam 5, Perindustrian Kamunting 3,<br>Kamunting Raya Industrial Estate, 34600 Kamunting, Perak<br>Darul Ridzuan, Malaysia. |
| Phone No.: | [phone] |
| Fax No.: | [phone] |

Date of Summary Prepared: 27th May 2021

#### 2.0 Identification of the subject device:

| Trade Name | : Violet Nitrile Powder Free Patient Examination Glove, Non<br>Sterile |
|-----------------------|------------------------------------------------------------------------|
| Common Name | : Patient Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Device Classification | : 1 |
| Regulation Number | : 21 CFR 880.6250 |
| Product Code | : LZA. |

#### 3.0 Predicate Device:

### K143289

Non-Sterile, Powder Free Nitrile Examination Gloves - Violet Color -LZA Company: YTY INDUSTRY (MANJUNG) SDN. BHD.

#### 4.0 Description of The Device:

Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile meets all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.

The powder free nitrile examination glove is manufactured from Nitrile latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

#### Indication for use: 5.0

A patient examination glove is a disposable device made of Nitrile latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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Image /page/4/Picture/0 description: The image shows the logo for the company "onetexx". The word "onetexx" is written in a bold, sans-serif font and is colored in a dark blue. To the right of the word is a circular logo that is partially filled in with dark blue and light blue.

#### 6.0 Summary of the Technological Characteristics of the Device:

The Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1.

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Image /page/5/Picture/0 description: The image shows the logo for "onetexx". The word "onetexx" is written in a dark blue sans-serif font. To the right of the word is a circular logo that is partially dark blue and partially light blue. The dark blue portion of the logo is in the shape of a square.

Table 1

| CHARACTERISTICS | | STANDARDS | DEVICE PERFORMANCE | | COMPARISON<br>ANALYSIS |
|----------------------|---|------------|--------------------------------|-------------------|----------------------------------------------|
| | | | PREDICATE<br>VIOLET | CURRENT<br>VIOLET | |
| 510(k) Number | - | | K143289 | K210587 | |
| Manufacturer(s) | - | | YTY Industry (Manjung) Sdn Bhd | Onetexx Sdn Bhd | Same |
| Material | | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | | Violet | Violet | Same |
| Product Code | - | | LZA | LZA | Same |
| Physical Properties | | ASTM D6319 | | | |
| Before Aging | | | | | |
| Tensile Strength: | | | 23.22-29.11Mpa | 32.35Mpa | Different but |
| Ultimate Elongation: | | | 520-580% | 568% | within the ASTM<br>standard |
| After Aging | | | | | |
| Tensile Strength: | | | 27.39-30.82 | 36.10Mpa | Different but |
| Ultimate Elongation: | | | 440-500% | 551% | within the ASTM<br>standard |
| Thickness: | | ASTM D6319 | | | |
| - Finger | | | 0.09-0.11mm | 0.10mm | Different but |
| - Palm | | | 0.06-0.07mm | 0.07mm | within the ASTM<br>standard |
| - Finger | | | 0.05-0.06mm | | Different but<br>within the ASTM<br>standard |
| Length: | | ASTM D6319 | 240 - 244mm | 246 - 255mm | Different but<br>within the ASTM<br>standard |
| Powder Free | | ASTM D6124 | 0.14mg/glove | 0.24 mg/glove | Different but<br>within the ASTM<br>standard |

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Image /page/6/Picture/0 description: The image shows the logo for "onetexx". The word "onetexx" is written in a dark blue sans-serif font. To the right of the word is a circular logo that is partially dark blue and partially light blue. The dark blue portion of the logo is in the shape of a square.

| | | DEVICE PERFORMANCE | | |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISON<br>ANALYSIS |
| | | VIOLET | VIOLET | |
| Biocompatibility | Primary Skin Irritation<br>- ISO 10993-10:2010<br>(E) & Consumer<br>Product Safety<br>Commission Title 16.<br>Chapter II, Part 1500 | Under the condition of the study<br>the device is non-irritant and<br>non-sensitizer | Under the conditions of this<br>study the device did not cause<br>an irritant response. The<br>Primary Irritant Response<br>Category is deemed 'Negligible' | Similar |
| | Dermal Sensitization-<br>ISO 10993-10: 2010<br>(E) & Consumer<br>Product Safety<br>Commission, Title 16,<br>Chapter II, Part<br>1500.3 (c) (4) | Under the condition of the study<br>the device is non-irritant and<br>non-sensitizer | Under the conditions of this<br>study the device did not<br>produce a skin sensitization<br>effect in the guinea pigs. | Similar |
| | Acute Systemic<br>Toxicity, ISO 10993-<br>11:2017 (E) | Not Tested | Under conditions of this study<br>the device did not induce any<br>systemic toxicity. | Different |

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Image /page/7/Picture/0 description: The image shows the logo for "onetexx". The text is in a dark blue color and is in a sans-serif font. To the right of the text is a circular icon that is partially dark blue and partially light blue.

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON<br>ANALYSIS |
|---------------------|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| | | PREDICATE<br>VIOLET | CURRENT<br>VIOLET | |
| Watertight (1000ml) | ASTM D5151:2019 | AQL 2.5<br>Result: 0 | Gloves passed AQL 1.5 | Different but<br>within the ASTM<br>standard |
| Indication for Use | - | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand or finger to<br>prevent contamination between<br>patient and examiner. | A patient examination glove is a<br>disposable device made of<br>synthetic rubber latex intended<br>for medical purposes that is<br>worn on the examiner's hand or<br>finger to prevent contamination<br>between patient and examiner. | Same |
| Size | Medical Glove<br>Guidance Manual -<br>Labeling | Medium | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Similar |
| Single use | Medical Glove<br>Guidance Manual -<br>Labeling | Single Use | Single Use | Same |

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Image /page/8/Picture/0 description: The image shows the onetexx logo. The word "onetexx" is written in a dark blue sans-serif font. To the right of the word is a circular logo in a light blue color with a dark blue square in the upper right quadrant.

There are no significant differences between the two products and are identical in terms of intended use, materials design, physical properties, color, thickness and biocompatibility.

#### 7.0 Summary of Non-Clinical Testing

The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below.

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Image /page/9/Picture/0 description: The image shows the logo for "onetexx". The word "onetexx" is written in a dark blue sans-serif font. To the right of the word is a circular logo that is partially dark blue and partially light blue. The dark blue portion of the logo is in the upper right corner, and the light blue portion is in the lower left corner.

| | | | Acceptance Criteria | | | Results | | |
|------------------------|----------------------------------------------------------------|--------------------------------------------------------------|------------------------|-----------------|-----------------|-----------------|----------------|--------|
| Test<br>Method | Standard | Purpose of Testing | | Before<br>aging | After<br>aging | Before<br>aging | After<br>aging | Status |
| Physical<br>Properties | ASTM D412<br>(Standard Test<br>Method for<br>Vulcanized Rubber | To evaluate the<br>tensile (tension)<br>properties of glove. | Tensile<br>strength | Min 14.0<br>MPa | Min 14.0<br>MPa | 32.35Mpa | 36.10Mpa | Pass |
| | and Thermoplastic<br>Elastomers-Tension) | | Ultimate<br>elongation | Min<br>500% | Min<br>400% | 568% | 551% | Pass |

| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | | Results | | Status |
|----------------|--------------------------------------------------------------------------------|--------------------------------------------------------------|---------------------|---------------------|-----------|--------|--------|
| Dimension | ASTM D3767<br>Standard Practice for<br>Rubber–<br>Measurement of<br>Dimensions | To measure the<br>length, width and<br>thickness of<br>glove | Length | Min 240 mm | Length | 249 mm | Pass |
| | | | Width | $95 \pm 10$ mm | Width | 98 mm | Pass |
| | | | Thickness | Finger - min 0.05mm | Thickness | 0.10mm | Pass |
| | | | | Palm - min 0.05mm | | 0.07mm | |

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Image /page/10/Picture/0 description: The image shows the logo for "onetexx". The text "onetexx" is written in a dark blue sans-serif font. To the right of the text is a circular graphic that is partially filled in with dark blue and light blue.

| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results | Status |
|----------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Watertight | ASTM D5151<br>(Standard Test<br>Method for<br>Detection of Holes<br>in Medical Gloves) | To detect holes<br>that leak water<br>and thereby<br>compromise the<br>usefulness of the<br>glove. | Sample size: 500 pcs<br>Inspection level: G1<br>AQL: 1.5, Acceptance No. 10 | The batch size for this<br>sampling is 150,001 to<br>500,000. Hence,<br>according to the single<br>sampling plan GI, the<br>sample to be drawn is<br>under code M<br>equivalent to 315<br>pieces with accept 10<br>and reject 11 to be<br>accepted under AQL<br>1.5. During the test, 0<br>piece was found with<br>leaks. Hence it falls<br>within the acceptance<br>criteria. | Pass |

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Image /page/11/Picture/0 description: The image shows the onetexx logo. The word "onetexx" is written in a bold, sans-serif font. To the right of the word is a circular icon that is partially filled in with a darker color. The logo is simple and modern.

| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results | Status |
|--------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------|---------------------------------------------------------------------------------|--------|
| Residual<br>Powder | ASTM D6124<br>(Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves) | To determine the<br>amount of<br>residual powder<br>and non-powder<br>solids found on<br>gloves. | Less than 2 mg per glove | Sample size : 5 pcs<br>Requirement : <2mg/glove<br>Result<br>:0.24mg/glove | Pass |

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Image /page/12/Picture/0 description: The image shows the logo for "onetexx". The word "onetexx" is written in a bold, sans-serif font in a dark color, likely black or a very dark shade of gray. To the right of the word "onetexx" is a stylized graphic element in a lighter color, possibly teal or cyan. The graphic element appears to be a partial or stylized representation of a circle or a "C" shape, with a portion of it filled in with a darker shade, creating a sense of depth or dimension.

#### 8.0 Summary of Clinical Testing:

No clinical study is included in this submission.

#### 9.0 Conclusion

The conclusion drawn from the non-clinical tests demonstrate that the subject Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K143289.