Disposable Nitrile Medical Examination Glove

K210691 · Jiangsu Cureguard Glove Co., Ltd. · LZA · Jul 30, 2021 · General Hospital

Device Facts

• Record ID: K210691
• Device Name: Disposable Nitrile Medical Examination Glove
• Applicant: Jiangsu Cureguard Glove Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jul 30, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Disposable Nitrile Medical Examination Glove 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 nitrile medical examination glove; non-sterile; blue color; ambidextrous design. Worn by healthcare professionals during patient examinations to provide a protective barrier against contamination. Device functions as a physical barrier; no electronic or mechanical components. Used in clinical settings; no specific operator specialty required. Benefits include reduction of cross-contamination risk between patient and examiner.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via ASTM D6319 (physical dimensions, tensile strength, elongation), ASTM D5151 (watertightness/holes), and ASTM D6124 (residual powder). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization).

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, powder-free, blue, non-sterile. Dimensions: Length ≥220mm (XS/S) or ≥230mm (M/L/XL). Thickness ≥0.05mm (finger/palm). Standards: ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands to prevent cross-contamination between patient and examiner.

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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July 30, 2021

Jiangsu Cureguard Glove Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K210691

Trade/Device Name: Disposable Nitrile Medical Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 15, 2021 Received: June 22, 2021

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.

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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 Ouality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K210691

Device Name Disposable Nitrile Medical Examination Glove

Indications for Use (Describe)

The Disposable Nitrile Medical Examination Glove is a disposable device intended for medical 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 (K210691)

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

#### 1.0 Submitter's Information

Name: Jiangsu Cureguard Glove Co., Ltd. Address: No.65 Shenzhen Road, The Economic Development Zone, Sugian , Jiangsu, 223800 China. Phone Number: [phone] Contact: Guo Hua Date of Preparation: Jun.30,2021

#### 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: Disposable Nitrile Medical Examination Glove Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS,S, M, L, XL

#### 3.0 Classification

Production code: LZA Regulation number: 21CFR880.6250 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/ Blue/ Black/ Pink Color 510(k) number: K171422

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### 5.0 Indication for Use

The Disposable Nitrile Medical Examination Glove 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 subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

| Item | Subject Device<br>(K210691) | Predicated Device<br>(K171422) |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | LZA | LZA |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 |
| Class | I | I |
| Intended Use | Disposable Nitrile Medical<br>Examination Glove is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's<br>hands to prevent<br>contamination between<br>patient and examiner. | The Disposable Powder Free<br>Nitrile Examination Glove,<br>White/ Blue/ Black/ Pink Color<br>is a disposable device<br>intended for medical purposes<br>that is worn on the examiner's<br>hands to prevent<br>contamination between patient<br>and examiner. |
| Material | Nitrile | Nitrile |
| Powdered or<br>Powered free | Powdered free | Powdered free |
| Design Feature | Ambidextrous | Ambidextrous |
| Colorant | Blue | White/ Blue/ Black/ Pink |
| Labeling Information | Single-use<br>indication,<br>powder free, device color,<br>device name, glove size and<br>quantity,<br>Non-Sterile | Single-use indication, powder<br>free, device color, device<br>name, glove size and quantity,<br>Non-Sterile |
| Dimensions(mm) | Length:<br>XS/S: $\geq$ 220;<br>M/L/XL: $\geq$ 230;<br>Width:<br>XS: 70 $\pm$ 10;<br>S: 80 $\pm$ 10; | Length: $\geq$ 230;<br>Width:<br>XS: 75 $\pm$ 5;<br>S: 85 $\pm$ 5;<br>M: 95 $\pm$ 5;<br>L: 105 $\pm$ 5; |

### 7.0 Technological Characteristic Comparison Table

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| | M: 95±10; | | XL: 115±5 | | |
|------------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|---------------------------------------------------------------------------|------------|
| | L: 110±10; | | | | |
| | XL: 120±10 | | | | |
| Thickness(mm) | Finger: ≥0.05; | | Finger: ≥0.05; | | |
| | Palm: ≥0.05 | | Palm: ≥0.05 | | |
| Physical<br>Properties | Before<br>Aging | Tensile<br>Strength | 14MPa, min | Tensile<br>Strength | 14MPa, min |
| | | Ultimate<br>Elongation | 500% min | Ultimate<br>Elongation | 500% min |
| | After<br>Aging | Tensile<br>Strength | 14MPa, min | Tensile<br>Strength | 14MPa, min |
| | | Ultimate<br>Elongation | 400%min | Ultimate<br>Elongation | 400%min |
| | Freedom from<br>Holes | Be free from holes when<br>tested in accordance with<br>ASTMD5151 AQL=2.5 | | Be free from holes when tested<br>in accordance with<br>ASTMD5151 AQL=2.5 | |
| | | Powder Content | | Meet the requirements of<br>ASTM D6124 | |
| Biocompatibility | | ISO 10993-10;<br>Under the conditions of the<br>study, not an irritant or a<br>sensitizer<br>ISO 10993-5<br>Under conditions of the<br>study, device extract is not<br>cytotoxic | | Comply with<br>ISO 10993-10<br><br>Comply with ISO 10993-5 | |

## 8.0 Discussion of Non-clinical and Performance Testing

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 D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.

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ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

| Test<br>Methodology | Purpose | Acceptance Criteria | Results |
|---------------------|--------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D6319 | Physical<br>Dimensions<br>Test | Length(mm):<br>XS/S:≥220;<br>M/L/XL: ≥230; | Lot1:<br>Length: >230 |
| | | Width(mm):<br>XS: 70±10;<br>S: 80±10;<br>M: 95±10;<br>L: 110±10;<br>XL: 120±10 | Width:<br>XS: 78-80;<br>S: 85-86<br>M: 95-96<br>L: 105-106<br>XL: 115-116 |
| | | | Lot2:<br>Length: >230<br>Width:<br>XS: 79-80<br>S: 85-86<br>M: 95-96<br>L: 105-106<br>XL: 115-116<br>Lot3:<br>Length: >230<br>Width:<br>XS: 78-80<br>S: 85-86<br>M: 95-96<br>L: 105-106<br>XL: 115-116<br>Pass |
| | | Thickness (mm) :<br>Finger: ≥0.05<br>Palm: ≥0.05 | Lot1:<br>Finger: 0.11-0.13<br>Palm: 0.06-0.07<br>Lot2:<br>Finger: 0.11-0.13<br>Palm: 0.06-0.07<br>Lot3: |

Table 2: Performance Characteristic Comparison

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| | | | | Finger: 0.11-0.13<br>Palm: 0.07<br>Pass | |
|------------|--------------------------------------------|---------------------------------------------|---------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | | Lot1:<br>0/125 leaks<br>Lot2:<br>0/125 leaks<br>Lot3:<br>0/125 leaks<br>Pass | |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | | Lot1:<br>0.09mg/glove;<br>Lot2:<br>0.06mg/glove;<br>Lot3:<br>0.08mg/glove;<br>Pass | |
| ASTM D412 | Physical properties | Before Aging | Tensile Strength | ≥14MPa | Lot 1:<br>28-36<br>Lot2:<br>28-33<br>Lot3:<br>23-33<br>Pass |
| | | | Ultimate Elongation | ≥500% | Lot1:<br>510-570<br>Lot 2:<br>480-565<br>Lot3:<br>515-566<br>Pass |
| | | After Aging | Tensile Strength | ≥14MPa | Lot 1:<br>27-33<br>Lot2:<br>28-33<br>Lot3:<br>28-32<br>Pass |
| | | | Ultimate Elongation | ≥500% | Lot1: |

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| | | Elongation | 485-535 |
|--------------|---------------|-----------------|----------------------------------------------------------------------------------------------------|
| | | | Lot 2: |
| | | | 480-530 |
| | | | Lot3: |
| | | | 485-533 |
| | | | Pass |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions<br>of the study, did not<br>show potential<br>toxicity to L-929<br>cells.<br>Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the<br>conditions of the<br>study, not an<br>irritant.<br>Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions<br>of the study, not a<br>sensitizer.<br>Pass |

# 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 subject device, K210691 is as safe, as effective, and performs as well as or better than the legally marketed predicated device, K171422.