Blue Nitrile Exam Glove, Powder Free

K210057 · Real Star Medical Technology Co., Ltd. · LZA · Mar 31, 2021 · General Hospital

Device Facts

• Record ID: K210057
• Device Name: Blue Nitrile Exam Glove, Powder Free
• Applicant: Real Star Medical Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Mar 31, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Blue Nitrile Exam Glove, Powder Free is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Story

Blue Nitrile Exam Glove, Powder Free; non-sterile, disposable, ambidextrous nitrile glove. Used by healthcare professionals in clinical settings to provide a protective barrier on hands or fingers. Prevents cross-contamination between patient and examiner. Device functions as a physical barrier; no active components or software. Manufactured to meet ASTM D6319-19 specifications for physical dimensions and properties. Provides protection during medical examinations.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified via ASTM D6319-19 (physical properties), ASTM D5151-06 (freedom from holes), ASTM D6124-06 (residual powder), and ISO 10993-5/10 (biocompatibility/cytotoxicity/irritation/sensitization).

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, powder-free, blue, non-sterile. Standards: ASTM D6319-19 (specifications), ASTM D5151-06 (holes), ASTM D6124-06 (powder), ISO 10993-5/10 (biocompatibility). No energy source, connectivity, or software.

Indications for Use

Indicated for use as a non-sterile, disposable patient examination glove worn on the hands or fingers of healthcare examiners to prevent cross-contamination between the patient and the 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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 31, 2021

Real Star Medical Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K210057

Trade/Device Name: Blue Nitrile Exam Glove, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: January 4, 2021 Received: January 11, 2021

Dear Boyle Wang:

We have reviewed vour 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

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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.

Jiangsong Jiang -S (Affiliate)

For Ryan Ortega, Ph D. Acting 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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# 510(k) Summary (K210057)

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

#### 1.0 Submitter's Information

Real Star Medical Technology Co., Ltd. Name: Address: Youdi Industry Park in Dongying District, Dongying City 257100, Shandong, China. Phone Number: [phone] Contact: Nie Jian Date of Preparation: Jan.04,2021

#### 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: Blue Nitrile Exam Glove, Powder Free Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): 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 Blue Nitrile Exam Glove, Powder Free is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger 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.

# 7.0 Technological Characteristic Comparison Table

| Item | Subject Device<br>(K210057) | Predicated Device<br>(K171422) | Remark |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | | | Same |
| Intended Use | The Blue Nitrile<br>Exam Glove,<br>Powder Free is a<br>non-sterile<br>disposable device<br>intended for<br>medical purposes<br>that is worn on the<br>examiner's hands<br>or finger to prevent<br>contamination<br>between patient<br>and examiner. | The Nitrile Powder<br>Free patient<br>examination glove<br>is a non-sterile<br>disposable device<br>intended for<br>medical purposes<br>that is worn on the<br>examiner's hands<br>or finger to prevent<br>contamination<br>between patient<br>and examiner. | Same |
| Powdered or<br>Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Labeling Information | Single-use<br>indication, powder<br>free, device color,<br>device name,<br>glove size and<br>quantity, Nitrile<br>Glove Powder | Single-use<br>indication, powder<br>free, device color,<br>device name, glove<br>size and quantity,<br>Disposable Powder<br>Free Nitrile | Same |

#### Table1-General Comparison

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| | Free Blue, Non-<br>Sterile | Examination Glove,<br>Non-Sterile | |
|--|----------------------------|-----------------------------------|--|
|--|----------------------------|-----------------------------------|--|

| | Designation | Size | | | | Tolerance | |
|------------------------------|----------------|-----------|----------|----------|-----------|-----------|------------|
| Predicate<br>Device(K171422) | Length, mm | XS<br>230 | S<br>230 | M<br>230 | L<br>230 | XL<br>230 | min |
| | Width, mm | 75 | 85 | 95 | 105 | 115 | $\pm 5$ |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | | min |
| | Palm | 0.05 | | | | | min |
| | Designation | Size | | | | Tolerance | |
| Subject Device<br>(K210057) | Length, mm | S<br>230 | M<br>230 | L<br>230 | XL<br>230 | | $\pm 10$ |
| | Width, mm | 80 | 95 | 110 | 120 | | $\pm 10$ |
| | Thickness, mm: | | | | | | |
| | Finger | 0.08 | | | | | $\pm 0.03$ |
| | Palm | 0.08 | | | | | $\pm 0.03$ |
| Remark | SIMILAR | | | | | | |

# Table2 Device Dimensions Comparison

Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19,so the differences do not raise any new safety or performance questions.

#### Table3 Performance Comparison

| Item | Subject device<br>(K210057) | Predicated device<br>(K171422) | Remark | | |
|------------------------|-----------------------------------------|-----------------------------------------|------------------------------|------------|------|
| Colorant | Blue | White/ Blue/<br>Black/ Pink | Same | | |
| Physical<br>Properties | Before<br>Aging | Tensile Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate Elongation | 500% min | 500% min | Same |
| | After<br>Aging | Tensile Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate Elongation | 400%min | 400%min | Same |
| | Comply with ASTM D6319 | | Comply with<br>ASTM<br>D6319 | Same | |
| Freedom from Holes | Be free from<br>holes when<br>tested in | Be free from<br>holes when<br>tested in | Same | | |

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| | accordance<br>with<br>ASTMD5151<br>AQL=2.5 | accordance<br>with<br>ASTMD5151<br>AQL=2.5 | |
|----------------|--------------------------------------------|----------------------------------------------|------|
| Powder Content | 0.03 mg per<br>glove | Meet the<br>requirements<br>of ASTM<br>D6124 | Same |

# Table4 Safety Comparison

| Item | Subject device<br>(K210057) | Predicated<br>device<br>(K171422) | Remark | |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------|---------|
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation (ISO<br>10993-10:2010<br>Biological<br>Evaluation of<br>Medical Devices -<br>Part 10: Tests For<br>Irritation And Skin<br>Sensitization)<br><br>Sensitization<br>(ISO 10993-<br>10:2010<br>Biological<br>Evaluation of<br>Medical Devices -<br>Part 10: Tests For<br>Irritation And Skin<br>Sensitization) | Under the<br>conditions of<br>the study, not<br>an irritant<br><br>Under<br>conditions of<br>the study, not<br>a sensitizer. | Comply with<br>ISO10993-<br>10 | Same |
| | Cytotoxicity (ISO<br>10993-5:2009<br>Biological<br>Evaluation of<br>Medical Devices -<br>Part 5: Tests For<br>In Vitro<br>Cytotoxicity) | Under<br>conditions of<br>the study,<br>device<br>extract is not<br>cytotoxic | / | Similar |

## 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

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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 D5151-06(Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves.

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

# 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 Blue Nitrile Exam Glove, Powder Free, is as safe, as effective, and performs as well as or better than the legally marketed predicated device cleared under K171422.