Disposable Medical Examination Nitrile Gloves

K232008 · Raxwell Industrial, LLC · LZA · Aug 8, 2023 · General Hospital

Device Facts

• Record ID: K232008
• Device Name: Disposable Medical Examination Nitrile Gloves
• Applicant: Raxwell Industrial, LLC
• Product Code: LZA · General Hospital
• Decision Date: Aug 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

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

Device Story

Disposable nitrile examination glove; worn on examiner's hands; prevents cross-contamination between patient and examiner. Available in sizes XS, S, M, L, XL, XXL; black color; non-sterile; ambidextrous design. Used in clinical settings by healthcare professionals. Provides physical barrier protection. Benefits patient and examiner by reducing risk of contamination during medical examinations.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ASTM D6319-19 (physical dimensions/properties), ASTM D5151 (watertightness), ASTM D6124 (powder content), and ISO 10993 (biocompatibility: cytotoxicity, irritation, sensitization, systemic toxicity) demonstrated.

Technological Characteristics

Nitrile material; non-powdered; ambidextrous; black color. Dimensions and physical properties meet ASTM D6319-19. Biocompatibility per ISO 10993-5, 10, and 11. Mechanical barrier principle. No energy source or software.

Indications for Use

Indicated for use as a disposable medical examination glove worn on the examiner's hands to prevent cross-contamination between patient and examiner. Suitable for use 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 Examination Glove (K213121)

Submission Summary (Full Text)

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August 8, 2023

Raxwell Industrial LLC % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

August 8, 2023 Re: K232008 Trade/Device Name: Disposable Medical Examination Nitrile Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 3, 2023 Received: July 6, 2023

Dear Dave Yungvirt:

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.

# Bifeng Qian -S

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

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K232008

Device Name

Disposable Medical Examination Nitrile Gloves

Indications for Use (Describe)

The Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands 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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# 510(k) SUMMARY

The assigned 510(K) number: K232008 Date Prepared: August 01, 2023

#### 1 Correspondent Contact Information

Bruce Cai (Contact Person) Humiss Inc. Tel: [phone] E-mail: [e-mail]

#### ଧ Submitter (Applicant)

Company name: Raxwell Industries LLC. Address: 0323 Bristol Bluff Ln, Richmond TX 77407, USA Contact Name: Xianda Yao Title: General manager Tel: [phone] E-mail: [e-mail]

* This is our first 510(k) submission for the below product, and there were no prior submissions for the subject device.

#### 3 Manufacturer information

Company name: Longgang City Ailiya Arts Crafts Co., Ltd. Address: 1st Floor Building 3, No. 999 Haijing Road, Longgang City, Wenzhou City, Zhejiang Province, 325810, China Contact Name: Youhai Lin Title: Plant director Phone: [phone] Fax: [phone] E-mail: [e-mail]

#### 4 DEVICE

| Name of Device | Disposable Medical Examination Nitrile Gloves |
|---------------------|-----------------------------------------------|
| Common Name | Medical examination gloves |
| Classification Name | Non-powdered Patient Examination Glove |
| Classification | Class I |
| Regulation Number | 21 CFR 880.6250 |
| Regulation Number | LZA |
| Review Panel: | General Hospital |

#### 5 PREDICATE DEVICE

Predicate Device 510k number: K213121

Predicate Device Manufacturer: Jiangsu Cureguard Glove Co., Ltd.

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#### 6 Device Description

#### 6.1 Indications for use of the device:

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

#### Device Description: 6.2

Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove is in black color, non-sterile and can be available in six specifications: XS, S, M, L, XL, XXL. It meets all of the requirements of ASTM standard D6319-19.

#### 7 Predicate Comparison

| Item | Subject Device | Predicated Device<br>(K213121) | Remark |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable Medical<br>Examination Nitrile Gloves<br>is a disposable device<br>intended for medical<br>purposes that is worn on<br>the examiner's hands to<br>prevent contamination<br>between patient and<br>examiner. | The Disposable Nitrile<br>Examination Glove is a<br>disposable device intended<br>for medical purposes that<br>is worn on the examiner's<br>hands to prevent<br>contamination between<br>patient and examiner. | Same |
| Material | Nitrile | Nitrile | Same |
| Powder or powder<br>free | Powder free | Powder free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Colorant | Black | Black/ Lavender/ Navy<br>Blue/Burgundy | Different<br>Analysis 1 |
| Labeling Information | Single-use indication,<br>powder free, device color,<br>device name, glove size<br>and quantity, non-sterile. | Single-use indication,<br>powder free, device color,<br>device name, glove size<br>and quantity, non-sterile. | Same |

Table 7.1 Disposable Medical Examination Nitrile Gloves Predicate Comparison

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| Dimensions (mm) | | Length (mm):<br>XS/S: ≥220;<br>M/L/XL/XXL: ≥230;<br>Width(mm):<br>XS: 70±10mm; S:<br>80±10mm; M: 95±10mm;<br>L: 110±10 mm; XL:<br>120±10 mm; XXL: 130±10 mm | | Length:<br>XS/S: ≥220; M/L/XL:<br>≥230;<br>Width:<br>XS: 70±10; S: 80±10; M:<br>95±10; L: 110±10; XL:<br>120±10. | | Different<br>Analysis 2 |
|------------------------|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-------------------------|
| Thickness (mm) | | Finger: ≥0.05; Palm: ≥0.05 | | Finger: ≥0.05; Palm: ≥0.05 | | Same |
| Physical<br>Properties | Before<br>Aging | Tensile<br>Strength | 14MPa,<br>min | Tensile<br>Strength | 14MPa,<br>min | Same |
| | | Ultimate<br>Elongation | 500% min | Ultimate<br>Elongation | 500% min | Same |
| | After<br>Aging | Tensile<br>Strength | 14MPa,<br>min | Tensile<br>Strength | 14MPa,<br>min | Same |
| | | Ultimate<br>Elongation | 400%min | Ultimate<br>Elongation | 400%min | Same |
| Freedom from Holes | | Be free from holes when<br>tested in accordance with<br>ASTMD5151 AQL=2.5 | | Be free from holes when<br>tested in accordance with<br>ASTMD5151 AQL=2.5 | | Same |
| Powder Content | | Meet the requirements of<br>ASTM D6124 | | Meet the requirements of<br>ASTM D6124 | | Same |
| Biocompatibility | | ISO 10993-5, under<br>conditions of the study,<br>device extract is cytotoxic | | ISO 10993-5, under<br>conditions of the study,<br>device extract is cytotoxic | | Same |
| | | ISO 10993-10, under the<br>conditions of the study, not<br>an irritant or a sensitizer | | ISO 10993-10, under the<br>conditions of the study, not<br>an irritant or a sensitizer | | Same |
| | | ISO 10993-11, under the<br>condition of acute systemic<br>toxicity test, the test article<br>did not show acute<br>systemic toxicity in vivo. | | ISO 10993-11, under the<br>condition of acute<br>systemic toxicity test, the<br>test article did not show<br>acute systemic toxicity in<br>vivo. | | Same |

Difference Analysis 1: The subject device (black) is a different color than the predicate devices (Black/ Lavender/ Navy Blue).

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Difference Analysis 2: The physical dimensions are different as compared to the predicate device. The subject device (black) has an additional XXL size which was not presented in the predicate device. All proposed device sizes meet the requirements of ASTM D6319-19.

#### 8 Summary of Non-clinical Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.

ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves

ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

ASTM D412-16e1, Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension

ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems ANSI ASQ Z1.4-2003 (R2018), Sampling Procedures and Tables for Inspection by Attributes

| Test Method | Purpose | Acceptance Criteria | Results |
|------------------|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM<br>D6319-19 | Physical<br>Dimensions<br>Test | Length (mm):<br>XS/S: ≥220;<br>M/L/XL/XXL: ≥230;<br>Width (mm):<br>XS: 70±10 mm; S: 80±10 mm; M:<br>95±10 mm; L: 110±10 mm; XL:<br>120±10 mm; XXL: 130±10 mm<br><br>Thickness (mm):<br>Finger: >0.05<br>Palm: >0.05 | Length(mm): Pass<br>XS/S: ≥220; Pass<br>M/L/XL: ≥230;<br>Width(mm): Pass<br>XS: 74-77mm; S:<br>83-87 mm; M: 96-<br>98 mm; L: 103-<br>107 mm; XL: 112-<br>115 mm; XXL:<br>120-123 mm;<br><br>Thickness (mm):<br>Finger: 0.123-<br>0.182/Pass<br>Palm: 0.112-<br>0.140/Pass |

Table 8 1 Summary of non-clinical performance testing

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| ASTM D5151 | Watertightness<br>Test for<br>Detection of<br>Holes | Meet the requirements of ASTM D5151, AQL2.5 | 0/125/Pass | | |
|--------------|-----------------------------------------------------|----------------------------------------------------|-----------------------------------------------------------------------------------------|--------|----------------------------|
| ASTM D6124 | Powder<br>Content | Meet the requirements of ASTM D6124 < 2.0 mg/glove | ≤0.23mg/Pass; | | |
| ASTM D412 | Physical<br>properties | Before<br>Aging | Tensile<br>Strength | ≥14MPa | 19.4-55.9 MPa<br>/Pass; |
| | | | Ultimate<br>Elongation | ≥500% | 502.367-682.033%<br>/Pass; |
| | | After<br>Aging | Tensile<br>Strength | ≥14MPa | 22.4-58.6MPa<br>/Pass; |
| | | | Ultimate<br>Elongation | ≥400% | 504.365-663.243%<br>/Pass; |
| ISO 10993-5 | Cytotoxicity | Non cytotoxic | Under conditions<br>of the study,<br>device extract is<br>cytotoxic. | | |
| ISO 10993-11 | Acute systemic<br>toxicity | Non- acute systemic toxicity | Under conditions<br>of the study, did<br>not show acute<br>systemic toxicity<br>in vivo | | |
| ISO 10993-10 | Irritation | Non-irritating | Under the<br>conditions of the<br>study, not an<br>irritant | | |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions<br>of the study, not a<br>sensitizer. | | |

#### 9 Summary of Clinical Testing

Clinical testing is not needed for this device.

## 10 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device Disposable Medical Examination Nitrile Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicated device in K213121.