Nitrile Glove Powder Free Black

K182528 · Haining Medical Products Co., Ltd. · LZA · Nov 15, 2018 · General Hospital

Device Facts

• Record ID: K182528
• Device Name: Nitrile Glove Powder Free Black
• Applicant: Haining Medical Products Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Nov 15, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Nitrile Glove Powder Free Black 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

Nitrile examination glove; disposable; non-sterile; ambidextrous; black color. Worn by healthcare examiners to provide a barrier against contamination between patient and examiner. Device functions as a physical barrier; material properties (tensile strength, elongation) and freedom from holes ensure protective integrity. Used in clinical settings. Benefits include reduced risk of cross-contamination during patient examinations.

Clinical Evidence

Bench testing only. No clinical data. Compliance verified via ISO 10993-10 (irritation/sensitization), ISO 10993-5 (cytotoxicity), ASTM D6124 (residual powder), ASTM D5151 (freedom from holes), and ASTM D6319 (physical properties).

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, disposable, non-sterile. Standards: ASTM D6319 (specification), ASTM D6124 (residual powder), ASTM D5151 (hole detection), ISO 10993-5/10 (biocompatibility).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands to prevent 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, White/Blue/ Black/ Pink Color (K171422)

Submission Summary (Full Text)

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November 15, 2018

Haining Medical Products Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, 200120 Cn

Re: K182528

Trade/Device Name: Nitrile Glove Powder Free Black Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: September 7, 2018 Received: September 14, 2018

Dear Boyle Wang:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Clarence W. Murray lii III -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K182528

Device Name Nitrile Glove Powder Free Black

Indications for Use (Describe)

The Nitrile Glove Powder Free Black is a disposable device intended 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 K182528

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

#### 1.0 Submitter's Information

Name: Haining Medical Products Co.,Ltd. Address: West Of Dianchang Road,Luannan County, Tangshan City , Hebei Province , 063500 China Phone Number: [phone] Contact: Zhiming Yao Date of Preparation: Nov.7, 2018

## Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: [phone] Email: [e-mail]

#### 2.0 Device information

Trade name: Nitrile Glove Powder Free Black Common name: Patient Examination Glove Classification name: Non-powdered patient examination glove Model(s): XS, S, M, L, XL

#### 3.0 Classification

Production code: LZA Regulation number: 21 CFR 880.6250 Classification: Class I Panel: General Hospital

#### 4.0 Predicate device information

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| Manufacturer: | Ever Global (Vietnam) Enterprise Corp |
|----------------|-------------------------------------------------------------------------------------|
| Device: | Disposable Powder Free Nitrile Examination Glove, White/<br>Blue/ Black/ Pink Color |
| 510(k) number: | K171422 |

#### 5.0 Indication for Use

The Nitrile Glove Powder Free Black is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

#### 6.0 Device description

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is black. The proposed device is non-sterile.

#### 7.0 Technological Characteristic Comparison Table

| Item | Proposed device | Predicated device | Comparison |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) number | K182528 | K171422 | |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Nitrile Glove<br>Powder Free<br>Black is a<br>disposable device<br>intended for<br>medical purposes<br>that is worn on the<br>examiner's hands<br>to prevent<br>contamination<br>between patient<br>and examiner. | The Disposable<br>Powder Free<br>Nitrile<br>Examination<br>Glove, White/<br>Blue/ Black/ Pink<br>Color is a<br>disposable<br>device intended<br>for medical<br>purposes that is<br>worn on the<br>examiner's<br>hands to prevent<br>contamination<br>between patient<br>and examiner. | Same |
| Powdered or | Powdered free | Powdered free | Same |

#### Table 1-General Comparison

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| Powered free | | | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Nitrile Glove Powder Free Black, Non-Sterile | Single-use indication, powder free, device color, device name, glove size and quantity, Disposable Powder Free Nitrile Examination Glove, Non-Sterile | Same |

# Table 2 Device Dimensions Comparison

| Predicate<br>Device(K171422) | Designation | Size | | | | | Tolerance |
|------------------------------|----------------|------|-----|-----|-----|-----|-----------|
| | | XS | S | M | L | XL | |
| | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
| | Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | | min |
| | Palm | 0.05 | | | | | min |
| Proposed Device<br>(K182528) | Designation | Size | | | | | Tolerance |
| | | XS | S | M | L | XL | |
| | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
| | Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | | min |
| | Palm | 0.05 | | | | | min |
| Comparison | SAME | | | | | | |

# Table 3 Performance Comparison

| Item | Proposed device (K182528) | Predicated device (K171422) | Comparison | | |
|---------------------|---------------------------|-----------------------------|------------|------------|------|
| Colorant | Black | White/ Blue/ Black/ Pink | Analysis 1 | | |
| Physical Properties | Before Aging | Tensile Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate | 500% min | 500% min | Same |

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| | | Elongation<br>Tensile<br>Strength | 14MPa, min | 14MPa, min | Same |
|--|------------------------|-----------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------|
| | After<br>Aging | Ultimate<br>Elongation | 400% min | 400% min | Same |
| | Comply with ASTM D6319 | | Comply with ASTM D6319 | Comply with ASTM D6319 | Same |
| | Freedom from Holes | | Be free from<br>holes when<br>tested in<br>accordance<br>with<br>ASTMD5151<br>AQL=2.5 | Be free from<br>holes when<br>tested in<br>accordance<br>with<br>ASTMD5151<br>AQL=2.5 | Same |
| | Powder Content | | 0.48 mg per<br>glove | Meet the<br>requirements<br>of ASTM<br>D6124 | Similar |

Analysis 1: The proposed device has different color to the predicate device.

| Table 4 Safety Comparison | |
|---------------------------|--|
|---------------------------|--|

| Item | | Proposed<br>device<br>(K182528) | Predicated<br>device<br>(K171422) | Remark |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|--------|
| Material | | Nitrile | Nitrile | Same |
| Biocompatibility | Irritation (ISO<br>10993-<br>10:2010<br>Biological<br>Evaluation of<br>Medical<br>Devices -<br>Part 10:<br>Tests For<br>Irritation And<br>Skin<br>Sensitization) | Under the<br>conditions of the<br>study, not an<br>irritant | Under the<br>conditions of<br>the study, not<br>an irritant | Same |
| | Sensitization<br>(ISO 10993-<br>10:2010<br>Biological<br>Evaluation of<br>Medical<br>Devices - | Under<br>conditions of the<br>study, not a<br>sensitizer. | Under<br>conditions of<br>the study, not<br>a sensitizer. | |

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| Part 10:<br>Tests For<br>Irritation And<br>Skin<br>Sensitization) | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|---|---------|
| Cytotoxicity<br>(ISO 10993-<br>5:2009<br>Biological<br>Evaluation of<br>Medical<br>Devices -<br>Part 5: Tests<br>For In Vitro<br>Cytotoxicity) | Under<br>conditions of the<br>study, did not<br>show potential<br>toxicity to L-929<br>cells. | / | Similar |

#### 8.0 Discussion of non-clinical and clinical test performed

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

ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

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

ASTM D5151-06 (Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves.

D6319-10(Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application.

Clinical testing is not needed for this device.

#### 9.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.