Disposable Medical Nitrile gloves

K213851 · Guangdong Xingcan Brothers Medical Technology Co.,Ltd · LZA · Mar 9, 2022 · General Hospital

Device Facts

• Record ID: K213851
• Device Name: Disposable Medical Nitrile gloves
• Applicant: Guangdong Xingcan Brothers Medical Technology Co.,Ltd
• Product Code: LZA · General Hospital
• Decision Date: Mar 9, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Disposable Medical Nitrile gloves intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Device Story

Disposable nitrile examination gloves; worn on hands of examiners to prevent cross-contamination between patient and examiner. Device consists of butadiene-acrylonitrile copolymers and blue colorant; features smooth surface and rolled rim at cuff. Available in sizes S, M, L, XL. Used in clinical settings by healthcare professionals. Provides physical barrier protection; benefits patient and examiner by reducing risk of contamination during medical examinations. Non-sterile, single-use.

Clinical Evidence

Bench testing only. No clinical data included. Performance testing demonstrated compliance with ASTM D6319-19 for physical dimensions, tensile strength, ultimate elongation (before/after aging), freedom from holes (AQL 2.5), and residual powder content. Biocompatibility testing per ISO 10993-10 (skin irritation/sensitization) and ISO 10993-11 (acute systemic toxicity) confirmed the device is not an irritant, sensitizer, or toxic.

Technological Characteristics

Material: Butadiene-Acrylonitrile Copolymers (CAS 9003-18-3) and Pigment Blue (CAS 147-14-8). Dimensions and physical properties meet ASTM D6319-19. Non-sterile, powder-free, single-use. Smooth surface with rolled rim cuff.

Indications for Use

Indicated for use by examiners to prevent cross-contamination between patient and examiner. Single-use, powder-free, non-sterile device for general patient examination.

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

• Patient Examination Gloves (K203593)

Submission Summary (Full Text)

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March 9, 2022

Guangdong Xingcan Brothers Medical Technology Co.,Ltd % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3. Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong China

Re: K213851

Trade/Device Name: Disposable Medical Nitrile gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: December 6, 2021 Received: December 10, 2021

Dear Cassie Lee:

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 mediation-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.

For Clarence W. Murray, III, 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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# Indications for Use

510(k) Number (if known) K213851

Device Name Disposable Medical Nitrile gloves

Indications for Use (Describe)

The Disposable Medical Nitrile gloves intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

| 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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## K213851 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

#### 1. Date of the summary prepared: December 6, 2021

#### 2. Submitter's Information

Sponsor Name: Guangdong Xingcan Brothers Medical Technology Co.,Ltd Address: Room B10, 4th Floor, No. 137 (plant A1), Pacific Industrial Zone, Xintang Town, Zengcheng District, Guangzhou Establishment Registration Number: Applying Post Code: 511300 Contact name: Suhai Yin Phone: [phone] Fax: [phone] E-mail: [e-mail]

#### Application Correspondent:

Contact Person: Ms. Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: [phone] Email: [e-mail]

### 3. Subject Device Information

Type of 510(k): Traditional Common Name: Polymer Patient Examination Glove Classification Name: Non-powdered patient examination glove Trade Name: Disposable Medical Nitrile gloves Specifications: Small (S), Medium (M), Large (L), X-large (XL) Review Panel: General Hospital Product Code: LZA Regulation Number: 21 CFR 880.6250 Regulatory Class: Class I

### 4. Predicate Device Information

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Sponsor: Guang Dong Kingfa SCI. & TECH.CO., LTD. Common Name: Polymer Patient Examination Glove Classification Name: Non-Powdered Patient Examination Glove Trade Name: Patient Examination Gloves 510(k) Number: K203593 Review Panel: General Hospital Product Code: LZA Regulation Number: 21 CFR 880.6250 Regulatory Class: Class I

#### 5. Device Description

The proposed devices are powder-free nitrile examination gloves, provided as non-sterile and disposable devices. The proposed devices are mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are composed of Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and blue colorant Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and a rolled rim at the cuff edge.

The Medical nitrile examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

#### 6. Intended Use / Indications for Use

The Disposable Medical Nitrile gloves intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

| Elements of | Subject Device | Predicate Device | Result |
|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Comparison | | | |
| Company | Guangdong Xingcan Brothers Medical<br>Technology Co.,Ltd | Guang Dong Kingfa SCI. &<br>TECH.CO., LTD. | -- |
| 510 (k) Number | K213851 | K203593 | -- |
| Trade Name | Disposable Medical Nitrile gloves | Patient Examination Gloves | -- |
| Product Code | LZA | LZA | Same |
| Classification<br>Name | Non-Powdered Patient Examination<br>Glove | Non-Powdered Patient<br>Examination Glove | Same |
| Classification | Class I | Class I | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Elements of<br>Comparison | Subject Device | Predicate Device | Result |
| Indications For<br>Use | The Disposable Medical Nitrile gloves<br>intended to be worn on the hands of<br>examiners to prevent contamination<br>between patient and examiner. This is a<br>single-use, powder-free, non-sterile<br>device. | The nitrile examination glove<br>is intended to be worn on the<br>hands of examiners to<br>prevent contamination<br>between patient and<br>examiner. This is a single-<br>use, powder-free, non-sterile<br>device. | Same |
| Material of Use | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Size<br>(ASTM D6319-<br>19) | Small, Medium, Large, X Large | Small, Medium, Large, X<br>Large | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Usage | Single usage | Single usage | Same |
| Dimensions<br>(ASTM D6319-<br>19) | Length:<br>For S: $\ge$ 220 mm<br>For M/L/XL: $\ge$ 230 mm | Length:<br>S (220mm min)<br>M (230mm min)<br>L (230mm min)<br>XL (230mm min)<br><br>Palm width<br>Small (80±10mm)<br>Medium (95±10mm)<br>Large (110±10mm)<br>X large (120±10mm) | Same |
| Physical<br>Properties<br>(ASTM D6319-<br>19) | Meets requirements of the ASTM D6319-<br>19<br><b>Before Aging:</b><br>Tensile Strength: $\ge$ 14Mpa<br>Ultimate Elongation: $\ge$ 500%<br><br>Meets requirements of the ASTM D6319-<br>19<br><b>After Aging:</b> | Meets requirements of the<br>ASTM D6319-19<br><b>Before Aging:</b><br>Tensile Strength: Min 14 Mpa<br>Ultimate Elongation: Min<br>500%<br><br>Meets requirements of the<br>ASTM D6319-19<br><b>After Aging:</b> | Same |
| Elements of<br>Comparison | Subject Device | Predicate Device | Result |
| | Tensile Strength: ≥14Mpa<br>Ultimate Elongation: ≥400% | Tensile Strength: Min 14Mpa<br>Ultimate Elongation: Min 400% | |
| Thickness<br>(ASTM D6319-<br>19) | Palm min. 0.05 mm<br>Finger min. 0.05 mm | Palm min. 0.05 mm<br>Finger min. 0.05 mm | Same |
| Powder Free<br>(ASTM D6319-<br>19) | ≤2 mg/glove | ≤2 mg/glove | Same |
| Freedom from<br>Holes (Water<br>Tight -1000 ml)-<br>ASTM D6319-19<br>(Cross<br>Reference<br>D5151) | Meets requirements of the ASTM D6319-19 | Meets requirements of the ASTM D6319-19 | Same |
| Biocompatibility<br>– Skin<br>Sensitization<br>(ISO 10993-<br>10:2010) | Under the conditions of the study not a<br>sensitizer | Under the conditions of the<br>study not a sensitizer | Same |
| Biocompatibility<br>– Skin Irritation<br>(ISO 10993-<br>10:2010) | Under the conditions of study not an<br>irritant | Under the conditions of study<br>not an irritant | Same |
| Biocompatibility<br>– Acute<br>Systemic<br>Toxicity (ISO<br>10993- 11:<br>2017) | Cytotoxicity is assessed via rationale.<br>Under the condition of acute systemic<br>toxicity test,<br>the test article did not show acute<br>systemic toxicity in vivo. | Cytotoxicity is assessed via<br>rationale. Under the condition<br>of acute systemic toxicity<br>test,<br>the test article did not show<br>acute systemic toxicity in<br>vivo. | Same |

#### 7. Technological Characteristics Comparison

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## 8. Test Summary

# 2.1 Summary of Non-Clinical Performance Testing

# 1) Performance Testing Summary:

| Test Method | Test Purpose | Acceptance Criteria | Test Results | Conclusion |
|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| ASMT D6319-19<br>Standard<br>Specification for<br>Nitrile Examination<br>Gloves for Medical<br>Application -<br>Physical<br>Dimensions Test | To determine<br>the width,<br>length, and<br>thickness of the<br>gloves | Width:<br>For S: $80\pm10$ mm<br>For M: $95\pm10$ mm<br>For L: $110\pm10$ mm<br>For XL: $120\pm10$ mm<br>Length:<br>For S: $\ge220$ mm<br>For M: $\ge230$ mm<br>For L: $\ge230$ mm<br>For XL: $\ge230$ mm | For Lot 20210825B:<br>Width:<br>For S: 83~86mm<br>For M: 91~92mm<br>For L: 104-106mm<br>For XL: 112-114mm<br>Length:<br>For S: 234~236mm<br>For M: 235~237mm<br>For L: 237~239mm<br>For XL: 237~239mm | Passed |
| | | | For Lot 20210827A:<br>Width:<br>For S: 83-85mm<br>For M: 91~93mm<br>For L: 104-106mm<br>For XL: 111-113mm<br>Length:<br>For S: 234~236mm<br>For M: 235~237mm<br>For L: 237~239mm<br>For XL: 237~239mm | |
| | | | For Lot 20210830A:<br>Width:<br>For S: 83-85mm<br>For M: 90~92mm<br>For L: 104-106mm<br>For XL: 112-115mm<br>Length:<br>For S: 234~236mm | |

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| | | For M: 235~237mm<br>For L: 237~240mm<br>For XL: 237~239mm |
|--|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| | Thickness:<br>Finger: ≥0.05mm<br>Palm: ≥0.05mm | For Lot 20210825B:<br>Finger:<br>For S/M: Pass at<br>0.11mm<br>For L/XL: Pass at<br>0.12mm<br>Palm:<br>For S/M/L/XL: Pass<br>at 0.08mm |
| | | For Lot 20210827A:<br>Finger:<br>For S: Pass at<br>0.11mm<br>For M/L/XL: Pass at<br>0.12mm<br>Palm:<br>For S/M/L/XL: Pass<br>at 0.08mm |
| | | For Lot 20210830A:<br>For S/M/L: Pass at<br>0.11mm<br>For XL: Pass at<br>0.12mm<br>Palm:<br>For S/M/L/XL: Pass<br>at 0.08mm |

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| ASMT D6319-19<br>Standard<br>Specification for<br>Nitrile Examination<br>Gloves for Medical<br>Application –<br>Physical<br>Dimensions Test | To determine<br>the tensile<br>strength and<br>ultimate<br>elongation<br>before and after<br>acceleration<br>aging | <b>Before Aging:</b><br>Tensile Strength:<br>$≥14Mpa$<br>Ultimate<br>Elongation: $≥500%$<br><b>After Aging:</b><br>Tensile Strength:<br>$≥14Mpa$<br>Ultimate<br>Elongation: $≥400%$ | <b>For all three lots:</b><br><b>Before Aging:</b><br>Tensile Strength:<br>$≥14Mpa$<br>Ultimate Elongation:<br>$≥500%$<br><b>After Aging:</b><br>Tensile Strength:<br>$≥14Mpa$ Ultimate<br>Elongation: $≥400%$ | Passed |
|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| ASTM D6319-19<br>(ASTM D5151-11)<br>Standard Test<br>Method for<br>Detection of Holes<br>in Medical Gloves | To determine<br>the holes in the<br>gloves | AQL 2.5 | For all three lots:<br>Pass at AQL 2.5 | Passed |
| ASMT D6319-19<br>(ASTM D6124-11)<br>Standard Test<br>Method for<br>Residual Powder<br>on Medical Gloves | To determine<br>the residual<br>powder in the<br>gloves | < 2.0 mg/glove | For Lot 20210825B:<br>For S/M/L/XL: Pass<br>at 0.22 mg/glove<br><br>For Lot 20210827A:<br>For S/M/L/XL: Pass<br>at 0.19 mg/glove<br><br>For Lot 20210830A:<br>For S/M/L/XL: Pass<br>at 0.20 mg/glove | Passed |

#### 2) Biocompatibility Testing Summary:

| Test Method | Test Purpose | Acceptance<br>Criteria | Test Results | Conclusion |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------|------------|
| ISO 10993-10<br>Biological evaluation<br>of medical devices -<br>Part 10: Tests for | To evaluate the<br>potential<br>intracutaneous<br>reactivity caused<br>by | Under the conditions<br>of study not an<br>irritation | Under the<br>conditions of<br>study not an<br>irritation | Passed |

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| skin irritation and<br>skin sensitization | intracutaneously<br>inject the extract to<br>rabbits | | | |
|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------|
| ISO 10993-10<br>Biological evaluation<br>of medical devices –<br>Part 10: Tests for<br>skin irritation and<br>skin sensitization | To determine the<br>skin sensitization<br>potential in guinea<br>pigs. | Under the conditions<br>of the study not a<br>sensitization | Under the<br>conditions of<br>the study not a<br>sensitization | Passed |
| ISO 10993-11:2017<br>Biological evaluation<br>of medical devices –<br>Part 11: Tests for<br>acute systemic<br>toxicity | The test item was<br>evaluated for<br>acute systemic<br>toxicity in ICR<br>mouse | Under the conditions<br>of the study no<br>systemic toxicity | Under the<br>condition of<br>acute systemic<br>toxicity test,<br>the test article<br>did not show<br>acute systemic<br>toxicity in vivo. | Passed |

## 2.1 Summary of Clinical Performance Test

No clinical study is included in this submission.

## 9. Final Conclusion:

The subject device is a safe, as effective, and perform as well as or better than the legally marketed predicated K203191.