Disposable Medical Nitrile Gloves

K211708 · Jiangsu Health-Peace Medical Technology Co., Ltd. · LZA · Aug 17, 2021 · General Hospital

Device Facts

• Record ID: K211708
• Device Name: Disposable Medical Nitrile Gloves
• Applicant: Jiangsu Health-Peace Medical Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 17, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Disposable medical nitrile gloves; worn on examiner's hands; barrier protection to prevent cross-contamination between patient and examiner. Device is non-sterile, powder-free, blue nitrile compound; finger-textured. Used in clinical or general medical settings. No electronic components or software.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D6319-19 (physical dimensions, tensile strength, elongation, hole detection, residual powder) and ISO 10993 (biocompatibility: skin irritation, sensitization, cytotoxicity, acute systemic toxicity).

Technological Characteristics

Nitrile compound; blue; finger-textured; non-sterile; single-use. Dimensions and physical properties comply with ASTM D6319-19. Biocompatibility testing per ISO 10993-5, 10993-10, and 10993-11.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. Suitable for over-the-counter use.

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

• LYDUS NITRILE EXAMINATION GLOVES, POWDER FREE (K203191)

Submission Summary (Full Text)

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August 17, 2021

Jiangsu Health-Peace Medical Technology Co. Ltd % Johnson Lui Consultant CNMED Consultant 31 Archer St Upper MT Gravatt, QLD 4122 Australia

Re: K211708

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: July 30, 2021 Received: August 3, 2021

Dear Johnson Lui:

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)

#### K211708

Device Name Disposable Medical Nitrile Gloves

Indications for Use (Describe)

Disposable Medical Nitrile Gloves are disposable device intended for medical purpose that is worn on the examiner's hand 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) Premarket Notification

# 510(K) Summary

K211708

Disposable Medical Nitrile Gloves

Preparation Date: Aug 18th, 2021

#### 1. SUBMITTER

Company Name: JIANGSU HEALTH-PEACE MEDICAL TECHNOLOGY CO. LTD Company Address: DongAn Youdian Street, Huangli Town, Wujin, Changzhou, CN 213155

Contact Person: Johnson Liu Telephone Number: [phone] Email: [e-mail]

#### 2. NAME OF THE DEVICE

Trade Name / Proprietary Name: Disposable Medical Nitrile Gloves Device Name: Disposable Medical Nitrile Gloves Device Classification Name: Patient Examination Gloves Device Class: Class I Device Classification Number: 21 CFR 880.6250 Product Code: LZA

#### 3. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE

Predicate Device: K203191 Applicant: Nathan Trading Co., Ltd Device Name: LYDUS NITRILE EXAMINATION GLOVES, POWDER FREE Device Classification Name: Patient Examination Gloves Device Classification Number: 21 CFR 880.6250 Device Class: Class I Product Code: LZA Review Panel: General Hospital

#### 4. DEVICE DESCRIPTION

The subject device in this 510(k) Notification is Disposable Medical Nitrile Gloves. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and nonsterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

### 5. INTENDED USE/Indications for Use

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

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### 6. TECHNOLOGICAL CHARACTERISTIC COMPARISON FOR THE PROPOSED AND PREDICATE DEVICES

| | DEVICE PERFORMANCE | | |
|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| CHARACTERISTICS | SUBJECT | PREDICATE | REMARKS |
| 510(k) Number | K211708 | K203191 | - |
| Device Name | Disposable Medical Nitrile Gloves | LYDUS Nitrile Examination<br>Gloves, Powder Free | - |
| Product Code | LZA | LZA | Same |
| Intended Use | Disposable Medical Nitrile Gloves is<br>disposable devices intended for<br>medical purpose that are worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. The device is for over the-<br>counter use. | LYDUS Nitrile Examination<br>Gloves, Powder Free is a<br>disposable device<br>intended for medical purposes<br>that is worn on the examiner's<br>hand or fingers to prevent<br>contamination between patient Same | |
| Materials of Use<br>(ASTM<br>D6910/D6910M-19) | Nitrile compound | Nitrile compound | Same |
| Color | Blue | Blue | Same |
| Texture | Finger Textured | Finger Textured | Same |
| Size<br>(ASTM D6319-19) | Small, Medium, Large, | Small, Medium, Large,<br>Extra Large | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Usage | Single usage | Single usage | Same |
| Dimensions<br>(ASTM D6319-19) | Length Min. 220 min Width Min<br>80+/-10 mm (for small size)<br>Length Min. 230 min Width Min<br>95+/-10 mm (for medium size)<br>Length Min. 230 min Width Min<br>110+/-10 mm (for large size) | Length Min. 220 min Width Min<br>80+/-10 mm (for small size)<br>Length Min. 230 min Width Min<br>95+/-10 mm (for medium size)<br>Length Min. 230 min Width Min<br>110+/-10 mm (for large size) | Same |
| Physical Properties<br>(ASTM D6319-19) | <b>Before Aging</b><br>Tensile Strength<br>Min 14 Mpa Ultimate Elongation<br>Min 500%<br><b>After Aging</b><br>Tensile Strength<br>Min 14 Mpa Ultimate Elongation<br>Min 400% | <b>Before Aging</b><br>Tensile Strength<br>Min 14 Mpa Ultimate<br>Elongation Min 500%<br><b>After Aging</b><br>Tensile Strength<br>Min 14 Mpa Ultimate<br>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 | Same |
| Powder Free<br>(ASTM D6319-19) | <2 mg/glove | <2 mg/glove | Same |
| | | | |
| Freedom from Holes<br>(Water Tight -1000 ml) -<br>ASTM D6319-19 (Cross<br>Reference D5151) | Passed | Passed | Same |
| Biocompatibility -<br>SKIN SENSITIZATION -<br>ISO 10993-10: 2010 (E) | Under the conditions of study not a<br>sensitizer | Under the conditions of study<br>not a sensitizer | Same |
| Biocompatibility -<br>SKIN IRRITATION - ISO<br>10993-10: 2010 (E) | Under the conditions of<br>the study not an irritant | Under the conditions of<br>the study not an irritant | Same |
| Biocompatibility - IN<br>VITRO CYTOTOXICITY<br>- ISO<br>10993-5: 2009(E) | Under the conditions of the<br>cytotoxicity study, mild<br>Systemic cytotoxicity (Grade 2)<br>observed. It complied with the<br>criteria in ISO 10993-5:2009. | Exhibit cytotoxic<br>reactivity at 100%<br>extract concentration<br>(Grade 4 with neat extract).<br>Non-cytotoxic<br>reactivity at 50%, 25%,<br>12.5% and 6.25%<br>extract concentration. | Similar |
| Biocompatibility -<br>ACUTE SYSTEMIC<br>TOXICITY - ISO 10993-<br>11: 2017(E) | Under the conditions of<br>the study no systemic toxicity | No systemic toxicity<br>under the experimental<br>conditions employed | Similar |
| Manufacturer(s) | JIANGSU HEALTH-PEACE<br>MEDICAL TECHNOLOGY CO.<br>LTD | Nathan Trading Co., Ltd | |

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There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319-19.

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## 7. NON-CLINICAL TESTING SUMMARY

#### PERFORMANCE DATA

| Test Method | Purpose | Acceptance Criteria | Result |
|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| ASMT D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application - Physical<br>Dimensions Test | To determine the<br>width, length, and<br>thickness of the<br>gloves | Width:<br>80 ± 10 mm (for small size)<br>95 ± 10 mm (for medium size)<br>110 ± 10 mm (for large size)<br>Length: (Minimum)<br>220 mm (for small size)<br>230 mm (for medium, large size)<br>Thickness: (Minimum)<br>Finger -0.05 mm (for all sizes)<br>Palm -0.05 mm (for all sizes) | Passed |
| ASMT D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application - Physical<br>Requirements Test | To determine the<br>tensile strength and<br>ultimate elongation<br>before and after<br>acceleration aging | Before Acceleration Aging:<br>Tensile Strength (MPa):14 (Minimum)<br>Ultimate Elongation (%): 500 (Minimum)<br>After Acceleration Aging:<br>Tensile Strength (MPa): 14 (Minimum)<br>Ultimate Elongation (%): 400 (Minimum) | Passed |
| ASTM D6319-19<br>(ASTM D5151-11)<br>Standard Test Method<br>for Detection of Holes in<br>Medical Gloves | To determine the<br>holes in the gloves | (Mean)<br>AQL 2.5 | Passed |
| ASMT D6319-19<br>(ASTM D6124-11)<br>Standard Test Method<br>for Residual Powder on<br>Medical Gloves | To determine the<br>residual powder in<br>the gloves | ≤ 2.0 mg/glove | 0.1<br>mg/glove,<br>Passed |

### BIO-COMPATIBILITY DATA

| Test Method | Purpose | Acceptance<br>Criteria | Result |
|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------|
| ISO 10993-10 Biological evaluation<br>of medical devices — Part 10: Tests<br>for skin irritation and skin<br>sensitization | To determine the potential of the<br>material under test to produce skin<br>irritation in rabbits | Under the<br>condition of<br>study not an<br>irritant | Under the condition of<br>study not an irritant |

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| ISO 10993-10 Biological evaluation<br>of medical devices — Part 10: Tests<br>for skin irritation and skin<br>sensitization | To determine the skin<br>sensitization potential of the<br>material both in terms of<br>induction and elicitation in<br>guinea pigs. | Under the<br>conditions of the<br>study not a<br>sensitizer. | Under the conditions of<br>the study not a sensitizer. |
|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------|
| ISO 10993-5 Biological evaluation of<br>medical devices — Part 5: Tests for<br>in vitro cytotoxicity | To evaluate the in vitro cytotoxic<br>potential of the test item (both<br>inner and outer surface) Extracts<br>in L-929 mouse fibroblasts cells<br>using elution method | Under the<br>conditions of<br>study, no more<br>than grade 2<br>cytotoxic<br>reaction | Mild (Grade 2)<br>cytotoxicity reaction<br>observed. |
| ISO 10993-11:2017 Biological<br>evaluation of medical devices—<br>Part 11: Tests for acute systemic<br>toxicity | The test item was evaluated for<br>acute systemic toxicity in ICR<br>Mice | Under the<br>conditions of the<br>study no systemic<br>toxicity | Under the conditions of<br>the study no systemic<br>toxicity |

### 8. CLINICAL TESTING SUMMARY

Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

#### 9. CONCLUSION

The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(k) submission, the Disposable Medical Nitrile Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device K203191- LYDUS Nitrile Examination Gloves, Powder Free.