Black Nitrile Powder Free Patient Examination Glove, Non Sterile

K210588 · Onetexx Sdn Bhd · LZA · Oct 31, 2021 · General Hospital

Device Facts

• Record ID: K210588
• Device Name: Black Nitrile Powder Free Patient Examination Glove, Non Sterile
• Applicant: Onetexx Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Oct 31, 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 intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, ambidextrous patient examination glove; manufactured from synthetic nitrile rubber latex. Designed for use by healthcare professionals or in over-the-counter settings to provide a barrier against contamination between examiner and patient. Features a smooth inner surface treatment to facilitate donning without the use of powder lubricants. Device is single-use. Provides physical barrier protection during medical examinations.

Clinical Evidence

No clinical data. Bench testing only, including physical properties (ASTM D412), dimensions (ASTM D3767), watertight integrity (ASTM D5151), residual powder (ASTM D6124), and biocompatibility (ISO 10993-5, 10993-10, 10993-11).

Technological Characteristics

Material: Nitrile synthetic rubber latex. Form factor: Ambidextrous, powder-free, non-sterile. Standards: ASTM D6319 (physical properties/dimensions), ASTM D5151 (watertight), ASTM D6124 (residual powder). Biocompatibility: ISO 10993-5 (cytotoxicity), 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

• Disposable Powder Free Nitrile Examination Glove, Black Color (K190942)

Submission Summary (Full Text)

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October 31, 2021

Onetexx SDN BHD Wava Truscott Consultant 189 Burkemeade Ct. Roswell, Georgia 30075

Re: K210588

Trade/Device Name: Black 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: September 25, 2021 Received: September 29, 2021

Dear Wava Truscott:

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 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.

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) K210588

Device Name BLACK 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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#### 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: 20th February 2021

#### 2.0 Identification of the subject device:

| Trade Name | : Black 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:

### K190942

Disposable Powder Free Nitrile Examination Glove, Black Color Company: Ever Growth (Vietnam) Co. Ltd.

#### 4.0 Description of The Device:

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

The powder free nitrile examination glove is manufactured from synthetic rubber 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.

#### 5.0 Indication for use:

A patient examination qlove is a disposable device made of synthetic rubber 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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#### 6.0 Summary of the Technological Characteristics of the Device:

The Black 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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### Table 1

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS | |
|-----------------------------------------------------------|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| | | PREDICATE<br>BLACK | CURRENT<br>BLACK | | |
| 510(k) Number | - | K190942 | | | |
| Manufacturer(s) | - | Ever Growth Enterprise<br>Corporation | Onetexx Sdn Bhd | Same | |
| Material | ASTM D6319 | Nitrile | Nitrile | Same | |
| Color | - | Black | Black | Same | |
| Physical Properties | ASTM D6319 | | | | |
| Before Aging<br>Tensile Strength:<br>Ultimate Elongation: | | 14Mpa, min<br>500% min | 32.35Mpa<br>568% | Different but<br>within the ASTM<br>standard | |
| After Aging<br>Tensile Strength:<br>Ultimate Elongation: | | 14Mpa, min<br>400% min | 36.10Mpa<br>551% | Different but<br>within the ASTM<br>standard | |
| Thickness:<br>- Finger<br>- Palm | ASTM D6319 | 0.05mm min<br>0.05mm min | 0.10mm<br>0.07mm | Different but<br>within the ASTM<br>standard | |
| Powder Free | ASTM D6124 | < 2mg per glove | 0.24 mg/glove | Different but<br>within the ASTM<br>standard | |
| | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE<br>PREDICATE<br>BLACK | CURRENT<br>BLACK | COMPARISON ANALYSIS |
| | | Primary Skin Irritation<br>- ISO 10993-10:2010<br>(E) & Consumer<br>Product Safety<br>Commission Title 16.<br>Chapter II, Part 1500 | Passes | The test material 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) | Passes | The test material did not<br>produce a skin sensitization<br>effect in the guinea pigs. | Similar |
| | Biocompatibility | Cytotoxicity - MEM<br>Elution, ISO 10993-5:<br>2009 (E) | Passes | The test material<br>demonstrated a cytotoxic<br>effect under the condition of<br>this study. Additional test i.e.<br>Acute Systemic Toxicity was<br>tested. | Different - but<br>additional test of<br>Acute Systemic<br>Toxicity is<br>conducted. |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS | |
| | | PREDICATE<br>BLACK | CURRENT<br>BLACK | | |
| Biocompatibility | Acute Systemic Toxicity, ISO 10993-11:2017 (E) | Not Applicable | The test item did not induce any systemic toxicity. | Different. | |
| Watertight (1000ml) | ASTM D5151:2019 | In accordance with ASTM D6319-10 and ASTM D5151-06 (reapproved 2011), G-1, AQL 2.5 | Gloves passed AQL 1.5 | Different, but within the ASTM standard. | |
| Intended use | - | The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. | A patient examination glove is a disposable device made of synthetic rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Same | |
| Size | Medical Glove Guidance Manual - Labeling | X Small<br>Small<br>Medium<br>Large<br>X Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Same | |
| Single use | Medical Glove Guidance Manual - Labeling | Yes | Single Use | Same | |

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

### 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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| Test<br>Method | Standard | Purpose of Testing | Acceptance Criteria | | Results | | Status | |
|------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------|--------------|--------------|-------------|----------|------|
| | | | Before aging | After aging | Before aging | After aging | | |
| Physical<br>Properties | ASTM D412<br>(Standard Test<br>Method for<br>Vulcanized Rubber<br>and Thermoplastic<br>Elastomers-Tension) | To evaluate the<br>tensile (tension)<br>properties of glove. | Tensile<br>strength | Min 14.0 MPa | Min 14.0 MPa | 32.35Mpa | 36.10Mpa | Pass |
| | | | Ultimate<br>elongation | Min 500% | Min 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 | 249mm | Pass |
| | | | Width | $95 \pm 10$ mm | Width | 98.0mm | Pass |
| | | | Thickness | Finger – min 0.05mm<br>Palm - min 0.05mm | Thickness | 0.10mm<br>0.07mm | Pass |

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| 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 |

| 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 :0.24mg/glove | Pass |

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#### 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 Black 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 K190942.