Medical nitrile examination gloves (Model: SH001)

K213600 · Jiangxi Sanhao Medical Instruments Co.,Ltd · LZA · Feb 19, 2022 · General Hospital

Device Facts

• Record ID: K213600
• Device Name: Medical nitrile examination gloves (Model: SH001)
• Applicant: Jiangxi Sanhao Medical Instruments Co.,Ltd
• Product Code: LZA · General Hospital
• Decision Date: Feb 19, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Medical nitrile examination gloves (Model: SH001) is 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

Single-use, powder-free, non-sterile nitrile examination glove; worn on hands by healthcare examiners to prevent cross-contamination between patient and examiner. Device features textured fingertips and rolled cuff; available in sizes S, M, L, XL. Manufactured from nitrile rubber with blue colorants (Butadiene-Acrylonitrile Copolymers and Pigment Blue). Used in clinical or general hospital settings. Provides a physical barrier; does not involve electronic processing or clinical decision-making output.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D6319-19, including physical dimensions, tensile strength, ultimate elongation (before/after aging), freedom from holes (ASTM D5151), and residual powder content (ASTM D6124). Biocompatibility testing performed per ISO 10993-10 (skin irritation/sensitization) and ISO 10993-11 (acute systemic toxicity).

Technological Characteristics

Nitrile rubber examination glove; powder-free; non-sterile. Features textured fingertips and rolled rim. Complies with ASTM D6319-19. Materials: Nitrile rubber, Butadiene-Acrylonitrile Copolymers (CAS 9003-18-3), Pigment Blue (CAS 147-14-8). Dimensions and physical properties (tensile strength, elongation) meet ASTM D6319-19 specifications.

Indications for Use

Indicated for use by examiners to prevent cross-contamination between patient and examiner. Suitable for general patient examination 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

• Patient Examination Gloves (K203593)

Submission Summary (Full Text)

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February 19, 2022

Jiangxi SanHao Medical Instruments Co.,Ltd % Cassie Lee Manger Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District, Guangzhou, Guangdong China

Re: K213600

Trade/Device Name: Medical nitrile examination gloves (Model: SH001) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: January 21, 2022 Received: January 24, 2022

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 (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

# Clarence W. Murray III -S

Clarence W. Murray, III, PhD 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) K213600

Device Name

Medical nitrile examination gloves (Model: SH001)

Indications for Use (Describe)

The Medical nitrile examination gloves (Model: SH001) is 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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# 510(k) Summary of K213600

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

#### 1. Date of the summary prepared: January 29, 2022

#### 2. Submitter's Information

Sponsor Name: Jiangxi SanHao Medical Instruments Co.,Ltd Address: Chengxi Industrial Park, Jishui County, Ji'an City, Jiangxi Province. China Post Code: 331699 Contact name: Wanqfenfanq (General Manager) Tel: [phone] Phone: [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, Minije 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: Medical nitrile examination qloves Model Name: SH001 Review Panel: General Hospital Product Code: LZA Requlation Number: 21 CFR 880.6250 Regulatory Class: Class I

#### 4. Predicate Device Information

Sponsor: Guang Dong Kingfa SCI. & TECH.CO., LTD.

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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 subject device is a powder-free nitrile examination glove, provided as a non-sterile and disposable device. The subject device is mainly made from nitrile and there are four sizes, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface with textured fingertips 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 Medical nitrile examination gloves (Model: SH001) is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powderfree, non-sterile device.

| Elements of<br>Comparison | Subject Device | Predicate Device | Result |
|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Company | Jiangxi SanHao Medical<br>Instruments Co.,Ltd | Guang Dong Kingfa SCI. &<br>TECH.CO., LTD. | -- |
| 510 (k) Number | K213600 | K203593 | -- |
| Trade Name | Medical nitrile examination gloves | Patient Examination Gloves | -- |
| Product Code | LZA | LZA | -- |
| Classification Name | Non-Powdered Patient<br>Examination 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 |
| Indications For Use | The Medical nitrile examination<br>Gloves (Model: SH001) is intended<br>to be worn on | The nitrile examination glove is<br>intended to be worn on the hands | Similar |
| Elements of<br>Comparison | Subject Device | Predicate Device | Result |
| | the hands of examiners to prevent<br>contamination between patient and<br>examiner. This is a single-use,<br>powder-free, non-sterile device. | of examiners to prevent<br>contamination between patient<br>and examiner. This is a single-<br>use, powder-free, non-sterile<br>device. | |
| Material of Use | Nitrile rubber | Nitrile rubber | Same |
| Color | Blue | Blue | Same |
| Texture | Finger Textured | Finger Textured | Same |
| Size<br>(ASTM D6319-19) | Small, Medium, Large, X Large | Small, Medium, Large, X Large | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Usage | Single usage | Single usage | Same |
| Dimensions<br>(ASTM D6319-19) | Length:<br>For S: ≥220 mm<br>For M/L/XL: ≥230 mm | Length:<br>S (220mm min)<br>M (230mm min)<br>L (230mm min)<br>XL (230mm min) | Same |
| | Width:<br>For S: 80±10mm<br>For M: 95±10 mm<br>For L: 110±10 mm<br>For XL: 120±10 mm | Palm width<br>Small (80±10mm)<br>Medium (95±10mm)<br>Large (110±10mm)<br>X large (120±10mm) | |
| Physical Properties<br>(ASTM D6319-19) | Meets requirements of the ASTM<br>D6319-19 | Meets requirements of the ASTM<br>D6319-19 | Same |
| | | | |
| | After Aging:<br>Tensile Strength: ≥14Mpa<br>Ultimate Elongation: ≥400% | After Aging:<br>Tensile Strength: Min 14Mpa<br>Ultimate Elongation: Min 400% | Same |
| | Thickness<br>(ASTM D6319-19) | Palm min. 0.05 mm<br>Finger min. 0.05 mm | Palm min. 0.05 mm<br>Finger min. 0.05 mm |
| Elements of<br>Comparison | Subject Device | Predicate Device | Result |
| Powder Free<br>(ASTM D6319-19) | ≤2 mg/glove | ≤2 mg/glove | Same |
| Freedom from Holes<br>(Water Tight -1000<br>ml)-ASTM D6319-19<br>(Cross Reference<br>D5151) | Meets requirements of the ASTM<br>D6319-19 | Meets requirements of the ASTM<br>D6319-19 | Same |
| Biocompatibility -<br>Skin Sensitization<br>(ISO 10993-10:2010) | Under the conditions of the study<br>not a sensitizer | Under the conditions of the study<br>not a sensitizer | Same |
| Biocompatibility -<br>Skin Irritation (ISO<br>10993-10:2010) | Under the conditions of study not<br>an irritant | Under the conditions of study not<br>an irritant | Same |
| Biocompatibility -<br>Acute Systemic<br>Toxicity (ISO 10993-<br>11: 2017) | Cytotoxicity is assessed via<br>rationale. Under the condition of<br>acute systemic toxicity test,<br>the test article did not show acute<br>systemic toxicity in vivo. | Cytotoxicity is assessed via<br>rationale. Under the condition of<br>acute systemic toxicity test,<br>the test article did not show acute<br>systemic toxicity in vivo. | Same |

#### 7. Comparison to predicate device and conclusion

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## 8. Test Summary

# 8.1 Summary of Non-Clinical Performance Testing

#### Performance Testing Summary: 1)

| Test Method | Test Purpose | Acceptance<br>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 the<br>width, length,<br>and thickness of<br>the 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: $\geq220$ mm<br>For M: $\geq230$ mm<br>For L: $\geq230$ mm<br>For XL: $\geq230$ mm | Lot Batch of<br>20210723C1:<br>Width:<br>For S: 79~84mm<br>For M: 93~97mm<br>For L: 104-107mm<br>For XL: 112-115mm<br>Length:<br>For S: 231~235mm<br>For M: 234~238mm | Passed |

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| | For L: 237~240mm<br>For XL: 238~243mm | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Lot Batch of<br><b>20210719A1:</b><br>Width:<br>For S: 80~83mm<br>For M: 93~96mm<br>For L: 104~107mm<br>For XL: 112~116mm<br>Length:<br>For S: 231~235mm<br>For M: 235~238mm<br>For L: 237~240mm<br>For XL: 239~243mm | |
| | Lot Batch of<br><b>20210726A0:</b><br>Width:<br>For S: 79~83mm<br>For M: 94~97mm<br>For L: 104~107mm<br>For XL: 112~116mm<br>Length:<br>For S: 232~235mm<br>For M: 235~238mm<br>For L: 237~240mm<br>For XL: 238~243mm | |
| Thickness:<br>Finger: ≥0.05mm<br>Palm: ≥0.05mm | For all three lots:<br>For S/M/L/XL:<br>Finger min: 0.13mm | |

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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 the<br>tensile strength<br>and ultimate<br>elongation<br>before and after<br>acceleration<br>aging | Before Aging:<br>Tensile Strength:<br>$\geq$ 14Mpa<br>Ultimate Elongation:<br>$\geq$ 500%<br>After Aging:<br>Tensile Strength:<br>$\geq$ 14Mpa<br>Ultimate Elongation:<br>$\geq$ 400% | For all three lots:<br>Before Aging:<br>Tensile Strength:<br>$\geq$ 14Mpa<br>Ultimate Elongation:<br>$\geq$ 500%<br>After Aging:<br>Tensile Strength:<br>$\geq$ 14Mpa Ultimate<br>Elongation: $\geq$ 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 the<br>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 the<br>residual powder<br>in the gloves | < 2.0 mg/glove | Lot Batch of<br>20210723C1:<br>For S/M/L/XL: Pass at<br>0.17 mg/glove<br><br>Lot Batch of<br>20210719A1:<br>For S/M/L/XL: Pass at<br>0.23 mg/glove<br><br>Lot Batch of<br>20210726A0:<br>For S/M/L/XL: Pass at<br>0.18 mg/glove | Passed |

# 2) Biocompatibility Testing Summary:

| Test Method | Test Purpose | Acceptance Criteria | Test Results | Conclusion |
|-------------|--------------|---------------------|--------------|------------|
|-------------|--------------|---------------------|--------------|------------|

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| ISO 10993-10<br>Biological evaluation<br>of medical devices -<br>Part 10: Tests for skin<br>irritation and skin<br>sensitization | To evaluate the<br>potential<br>intracutaneous<br>reactivity caused by<br>intracutaneously inject<br>the extract to rabbits | Under the<br>conditions of the<br>study not an<br>irritant | Under the<br>conditions of<br>study not an<br>irritant | Passed |
|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------|
| ISO 10993-10<br>Biological evaluation<br>of medical devices -<br>Part 10: Tests for skin<br>irritation and skin<br>sensitization | To determine the skin<br>sensitization potential<br>in guinea pigs. | Under the<br>conditions of study<br>not a sensitizer | Under the<br>conditions of the<br>study not a<br>sensitizer | Passed |
| ISO 10993-11:2017<br>Biological evaluation<br>of medical devices -<br>Part 11: Tests for<br>acute systemic toxicity | The test item was<br>evaluated for acute<br>systemic toxicity in<br>ICR mouse | Under the<br>conditions of the<br>study no systemic<br>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 |

### 8.2 Summary of Clinical Performance Test

No clinical study is included in this submission.

### 9. Final Conclusion:

The conclusions drawn from the non-clinical testing demonstrate that the Medical nitrile examination gloves (Model: SH001) are as safe, as effective, and perform as well as or better than the legally marketed predicate (K203593).