Nitrile Glove Powder Free White

K183068 · Haining Medical Products Co., Ltd. · LZA · Dec 21, 2018 · General Hospital

Device Facts

• Record ID: K183068
• Device Name: Nitrile Glove Powder Free White
• Applicant: Haining Medical Products Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Dec 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Nitrile Glove Powder Free White 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, non-sterile, powder-free nitrile examination glove; ambidextrous design; available in sizes XS, S, M, L, XL. Worn by healthcare examiners to provide a barrier against cross-contamination between patient and examiner. Device is a physical barrier; no electronic or mechanical components. Used in clinical or medical environments. Benefits include protection against contamination during patient examinations.

Clinical Evidence

No clinical data. Bench testing only. Compliance demonstrated with ASTM D6319 (physical properties), ASTM D5151 (freedom from holes), ASTM D6124 (residual powder), and ISO 10993 series (biocompatibility: cytotoxicity, irritation, and sensitization).

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, powder-free, non-sterile. Dimensions: 230mm length; 75-115mm width; 0.05mm min thickness. Standards: ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-5:2009, ISO 10993-10:2010.

Indications for Use

Indicated for use as a disposable, non-sterile, powder-free nitrile examination glove worn on the examiner's hands to prevent contamination between patient and examiner in a medical setting.

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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 21, 2018

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

Re: K183068

Trade/Device Name: Nitrile Glove Powder Free White Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: October 29, 2018 Received: November 5, 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) K183068

Device Name Nitrile Glove Powder Free White

Indications for Use (Describe)

The Nitrile Glove Powder Free White 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 K183068

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

#### 1.0 Submitter's Information

Haining Medical Products Co.,Ltd. Name: Address: West Of Dianchang Road,Luannan County, Tangshan City , Hebei Province , 063500 China Phone Number: [phone] Contact: Zhiming Yao Date of Preparation: Dec.17.2018

#### 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 White Common name: Patient Examination Gloves Regulation name: Non-powdered patient examination glove Model(s): XS, S. M. L. XL

#### 3.0 Classification

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

#### 4.0 Predicate Device Information

Manufacturer: Ever Global (Vietnam) Enterprise Corp Device: Disposable Powder Free Nitrile Examination Glove, White/

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Blue/ Black/ Pink Color 510(k) number: K171422

### 5.0 Indication for Use

The Nitrile Glove Powder Free White 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 white. The proposed device is non-sterile.

#### 7.0 Technological Characteristic Comparison Table

| Table1-General Comparison | | | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Item | Proposed Device<br>(K183068) | Predicated Device<br>(K171422) | Remark |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Nitrile Glove<br>Powder Free white<br>is a disposable<br>device intended<br>for medical<br>purposes that is<br>worn on the<br>examiner's hands<br>to prevent<br>contamination<br>between patient<br>and examiner. | The Disposable<br>Powder Free Nitrile<br>Examination Glove,<br>White/ Blue/ Black/<br>Pink Color 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. | Same |
| Powdered or<br>Powered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single-use<br>indication, powder<br>free, device color,<br>device name,<br>glove size and | Single-use<br>indication, powder<br>free, device color,<br>device name, glove<br>size and quantity | Same |

#### Table1-General Comparison

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| quantity, Nitrile<br>Glove Powder<br>Free White, Non-<br>Sterile | Disposable Powder<br>Free Nitrile<br>Examination Glove,<br>Non-Sterile |
|------------------------------------------------------------------|------------------------------------------------------------------------|
|------------------------------------------------------------------|------------------------------------------------------------------------|

## Table2 Device Dimensions Comparison

| Predicate<br>Device(K171422) | Designation | Size | | | | | |
|------------------------------|----------------|------|-----|-----|-----|-----|-----------|
| | | XS | S | M | L | XL | Tolerance |
| | 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>(K183068) | Designation | Size | | | | | |
| | | XS | S | M | L | XL | Tolerance |
| | 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 |
| Remark | Same | | | | | | |

## Table3 Performance Comparison

| Item | | Proposed device<br>(K183068) | Predicated device<br>(K171422) | Remark |
|------------------------|-----------------|----------------------------------------------|----------------------------------------------|-----------|
| Colorant | | White | White/ Blue/<br>Black/ Pink | Analysis1 |
| Physical<br>Properties | Before<br>Aging | Tensile Strength<br>14MPa, min | 14MPa, min | Same |
| | | Ultimate Elongation<br>500% min | 500% min | Same |
| | After<br>Aging | Tensile Strength<br>14MPa, min | 14MPa, min | Same |
| | | Ultimate Elongation<br>400%min | 400%min | Same |
| | | Comply with ASTM D6319 | Comply with ASTM<br>D6319 | Same |
| Freedom from Holes | | Be free from holes when tested in accordance | Be free from holes when tested in accordance | Same |

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| | with<br>ASTMD5151<br>AQL=2.5 | with<br>ASTMD5151<br>AQL=2.5 | |
|----------------|------------------------------|-------------------------------------|---------|
| Powder Content | 0.47 mg per glove | Meet the requirements of ASTM D6124 | Similar |

Analysis1: The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility test, the test results shown that the color difference do not effect on the safety of proposed device

| Item | | Proposed<br>device<br>(K183068) | Predicated<br>device<br>(K171422) | Remark |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------|---------|
| Material | | Nitrile | Nitrile | Same |
| Biocompatibility | Irritation (ISO<br>10993-10:2010<br>Biological<br>Evaluation of<br>Medical Devices -<br>Part 10: Tests For<br>Irritation And Skin<br>Sensitization) | Under the<br>conditions of<br>the study, not<br>an irritant | | |
| | Sensitization<br>(ISO 10993-<br>10:2010<br>Biological<br>Evaluation of<br>Medical Devices -<br>Part 10: Tests For<br>Irritation And Skin<br>Sensitization) | Under<br>conditions of<br>the study, not<br>a sensitizer. | Comply with<br>ISO10993-<br>10 | Same |
| | Cytotoxicity (ISO<br>10993-5:2009<br>Biological<br>Evaluation of<br>Medical Devices -<br>Part 5: Tests For<br>In Vitro<br>Cytotoxicity) | Under<br>conditions of<br>the study,<br>device<br>extract is not<br>cytotoxic | / | Similar |

#### Table4 Safety Comparison

#### 8.0 Discussion of Non-clinical and Performance Testing

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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.

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

#### 9.0 Discussion of Clinical and Performance Testing

Clinical testing is not needed for this device.

#### 10.0 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.