Disposable Medical Nitrile Examination Gloves (Non-Sterile)

K211075 · Jiangsu Cherish Medical Technology Co., Ltd. · LZA · Aug 5, 2021 · General Hospital

Device Facts

• Record ID: K211075
• Device Name: Disposable Medical Nitrile Examination Gloves (Non-Sterile)
• Applicant: Jiangsu Cherish Medical Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 5, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Disposable nitrile examination gloves; worn on examiner's hands; barrier protection to prevent cross-contamination between patient and examiner. Device is non-sterile, powder-free, blue, and finger-textured. Used in clinical or general medical settings. Provides physical barrier; protects both patient and healthcare provider from potential contaminants. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D6319-19 for physical dimensions, tensile strength, elongation, freedom from holes, and residual powder. Biocompatibility testing performed per ISO 10993-5, 10993-10, and 10993-11.

Technological Characteristics

Nitrile compound; finger-textured; blue; non-sterile; single-use. Dimensions and physical properties comply with ASTM D6319-19. Biocompatibility per ISO 10993 series. No energy source, connectivity, or software.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-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 5, 2021

Jiangsu Cherish Medical Technology Co., Ltd % Johnson Liu Consultant Cnmed Consultant 31 Archer St Upper MT Gravatt, QLD 4122 Australia

Re: K211075

Trade/Device Name: Disposable Medical Nitrile Examination Gloves (Non-Sterile) Regulatory Class: 21 CFR 880.6250 Product Code: LZA Dated: July 20, 2021 Received: July 26, 2021

Dear Johnson Liu:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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, 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)

K211075

Device Name

Disposable Medical Nitrile Examination Gloves (Non-Sterile)

Indications for Use (Describe)

Disposable Medical Nitrile Examination 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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Image /page/3/Picture/1 description: The image shows the word "Cherish" in a blue, sans-serif font. The word is written in all lowercase letters except for the first letter, which is capitalized. There is a small "TM" symbol in the upper right corner of the word. The word is the main focus of the image and is centered.

# 510(K) Summary (K211075)

#### DISPOSABLE MEDICAL NITRILE EXAMINATION GLOVES, NON-STERILE

Preparation Date: August 5th, 2021

#### 1. SUBMITTER

Company Name: JIANGSU CHERISH MEDICAL TECHNOLOGY CO., LTD Company Address: No. 55 Maqianan Chaoyang Road, Jiaoxi Centralized Industrial Zone Changzhou. CN 213000

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

#### 2. NAME OF THE DEVICE

Trade Name / Proprietary Name: Cherish Nitrile Examination Gloves Device Name: Disposable Medical Nitrile Examination Gloves (Non-Sterile) 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 Examination Gloves, Non-sterile. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (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. Indications for Use

Disposable Medical Nitrile Examination Gloves, Non-sterile 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 | K211075 | K203191 | - |
| Device Name | Disposable Medical Nitrile<br>Examination Gloves<br>Powder Free, Non sterile | LYDUS Nitrile Examination<br>Gloves, Powder Free | - |
| Product Code | LZA | LZA | Same |
| Intended Use/Indications for<br>Use | Disposable Nitrile Examination<br>Gloves Non-sterile is disposable<br>devices intended for medical purpose<br>that are worn on the examiner's hand<br>to prevent contamination between<br>patient and examiner. The device is<br>for over the-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<br>and examiner. | 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,<br>Extra 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. 230 min Width Min<br>95+/-10 mm (for medium size) | Length Min. 230 min Width<br>Min 95+/-10 mm (for medium<br>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<br>an irritant | Under the conditions of study<br>not an irritant | Same |
| Biocompatibility -<br>SKIN IRRITATION - ISO<br>10993-10: 2010 (E) | Under the conditions of<br>the study not a sensitizer | Under the conditions of<br>the study not a<br>sensitizer | Same |
| Biocompatibility - IN<br>VITRO CYTOTOXICITY<br>- ISO<br>10993-5: 2009(E) | Under the condition of the study,<br>the test article showed no<br>cytotoxicity to L-929 cells and<br>cytotoxic level was 0. | 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 Cherish Medical<br>Technology Co., 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 for<br>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: (for Small size)<br>$80\pm10$ mm | Width: (for small size)<br>82mm (Minimum)<br>82 mm (Mean)<br>85 mm (Maximum) |
| | | Length: (for Small size)<br>220 mm (Minimum) | Length: (for small size)<br>232 mm (Mean)<br>230 mm (Minimum) |
| | | Thickness: (for Small size)<br>Finger –<br>0.05 mm (Minimum)<br>Palm –<br>0.05 mm (Minimum) | Thickness: (for small size)<br>Finger –<br>0.13 mm (Mean)<br>0.12 mm (Minimum)<br>Palm –<br>0.08 mm (Mean)<br>0.08 mm (Minimum) |
| | | | Passed |
| | | Width: (for Medium size)<br>$95\pm10$ mm | Width: (for medium size)<br>91 mm (Minimum)<br>92 mm (Mean)<br>93 mm (Maximum) |
| | | Length: (for Medium size)<br>230 mm (Minimum) | Length: (for medium size)<br>242 mm (Mean)<br>240 mm (Minimum) |
| | | Thickness: (for Medium size)<br>Finger –<br>0.05 mm (Minimum)<br>Palm–<br>0.05 mm (Minimum) | Thickness: (for medium size)<br>Finger –<br>0.14 mm (Mean)<br>0.13 mm (Minimum)<br>Palm –<br>0.09 mm (Mean)<br>0.08 mm (Minimum) |
| | | | Passed |
| | | Width: (for Large size)<br>$110\pm10$ mm | Width: (for large size)<br>108 mm (Minimum)<br>109 mm (Mean)<br>110 mm (Maximum) |
| | | Length: (for large size)<br>230 mm (Minimum) | Length: (for large size)<br>239 mm (Mean)<br>237 mm (Minimum) |
| | | Thickness: (for Large size)<br>Finger–<br>0.05 mm (Minimum)<br>Palm<br>0.05 mm (Minimum) | Thickness: (for large size)<br>Finger –<br>0.14 mm (Mean)<br>0.13 mm (Minimum)<br>Palm –<br>0.09 mm (Mean)<br>0.09 mm (Minimum) |
| | | | Passed |
| ASMT D6319-19<br>Standard Specification for<br>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: (for Extra-large size)<br>120±10 mm<br>Length: (for Extra-large size)<br>230 mm (Minimum)<br>Thickness: (for Extra-large size)<br>Finger -<br>0.05 mm (Minimum)<br>Palm -<br>0.05 mm (Minimum) | Width: (for extra-large size)<br>121 mm (Minimum)<br>122 mm (Mean)<br>125 mm (Maximum)<br>Length: (for extra-large size)<br>243 mm (Mean)<br>240 mm (Minimum)<br>Thickness: (for extra- large size)<br>Finger -<br>0.14 mm (Mean)<br>0.13 mm (Minimum)<br>Palm -<br>0.09 mm (Mean)<br>0.08 mm (Minimum)<br>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):<br>14 (Minimum)<br>Ultimate Elongation (%):<br>500 (Minimum)<br>After Acceleration Aging:<br>Tensile Strength (MPa):<br>14 (Minimum)<br>Ultimate Elongation (%):<br>400 (Minimum) | Before Acceleration Aging:<br>Tensile Strength (MPa):<br>31 (Mean)<br>17 (Minimum)<br>Ultimate Elongation (%):<br>563 (Mean)<br>520 (Minimum)<br>After Acceleration Aging:<br>Tensile Strength (MPa):<br>41 (Mean)<br>28 (Minimum)<br>Ultimate Elongation (%):<br>555 (Mean)<br>524 (Minimum)<br>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 | 1.02 mg/glove, Passed |

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## 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<br>of medical devices - Part 5: Tests<br>for 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 non<br>cytotoxic | Under the condition of the<br>study, the test article<br>showed no cytotoxicity to<br>L-929 cells and cytotoxic<br>level was 0. |
| 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 Swiss<br>Albino 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 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 Examination Gloves Non sterile 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.