Powder Free Nitrile Patient Examination Gloves, Blue Color

K210779 · Shandong Shangwei Medical Products Co., Ltd. · LZA · Nov 10, 2021 · General Hospital

Device Facts

• Record ID: K210779
• Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Color
• Applicant: Shandong Shangwei Medical Products Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Nov 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Non-sterile, disposable nitrile examination gloves; blue color. Worn by healthcare examiners on hands or fingers. Acts as physical barrier to prevent contamination between patient and examiner. Used in clinical or medical settings. Provides protection for both patient and examiner during examinations.

Clinical Evidence

No clinical data. Bench testing only. Device performance verified against ASTM D6319-10 (dimensions, physical properties), ASTM D6124-06 (residual powder), and ASTM D5151-19 (pinholes). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Material: Nitrile. Form factor: Disposable, non-sterile, blue, ambidextrous gloves. Sizes: Small, Medium, Large, X-large. Standards: ASTM D6319-10 (dimensions, physical properties), ASTM D6124-06 (residual powder), ASTM D5151-19 (pinholes). Biocompatibility: ISO 10993-5, ISO 10993-10, ISO 10993-11.

Indications for Use

Indicated for use as a non-sterile, disposable medical glove worn on the examiner's hand or finger 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

• Powder Free Nitrile Patient Examination Glove, Blue Color (K120970)

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). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 10, 2021

Shandong Shangwei Medical Products Co.,Ltd % Chu Xiaoan Official Correspondent Beijing Easy-Link Company Rm. F302 Bldg., 41. Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang, Chaoyung District Beijing, 100121 China

Re: K210779

Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 17, 2021 Received: October 19, 2021

Dear Chu Xiaoan:

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 medical devices and radiation-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.

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

Device Name

Powder Free Nitrile Patient Examination Gloves, Blue Color

Indications for Use (Describe)

Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger 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

## K210779

This summary of 510(k) is being submitted in accordance with 21 CFR 807.

Premarket Notification [510(k)] Summary

#### 1.0 Submitter:

Submitter's name: Shandong Shangwei Medical Products Co.,Ltd Submitter's address: North Road, Fumin Avenue, Qinghe Street, Caoxian County, Heze City, Shandong Province, 274400,P.R. China Name of contact person: Ms. Li Hua Phone number: 0086-530-2069711 Date of preparation: 2021-11-08

#### 2.0 Name of the Device

Proprietary/Trade name: Powder Free Nitrile Patient Examination Gloves, Blue Color Common Name: Patient Examination gloves Classification Name: Non-powdered Patient examination glove Device Classification: I Regulation: 21 CFR 880.6250 Panel: General Hospital Product Code: LZA

#### 3.0 Predicate device

Device Name: Powder Free Nitrile Patient Examination Glove, Blue Color Company name: Tangshan Zhonghong Pulin Plastic Co., Ltd. 510(K) Number: K120970

### 4.0 Device Description:

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.

## 5.0 Indications for Use Statement:

Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

| Features &<br>Description | Predicate Device<br>(K120970) | Subject Device<br>(K210779) | Result of<br>Comparison |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Product name | Powder Free Nitrile Patient<br>Examination Glove, Blue Color | Powder Free Nitrile Patient<br>Examination Gloves, Blue Color | Same |
| Regulation Number | 21CFR880.6250 | 21CFR880.6250 | Same |
| Product Code | LZA | LZA | Same |
| Color | Blue | Blue | Same |
| Size | Small/ Medium/<br>Large/X large | Small/ Medium/<br>Large/X large | Same |
| Indications for Use | Powder Free Nitrile Patient<br>Examination Glove, Blue Color<br>is a disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand or<br>finger to prevent contamination<br>between patient and examiner. | Powder Free Nitrile Patient<br>Examination Gloves, Blue Color is<br>a disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand or finger to<br>prevent contamination between<br>patient and examiner. | Same |

### 6.0 Technological Characteristic Comparison:

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| Device Description<br>and Specifications | Meets ASTM D6319-10 | | Meets ASTM D6319-10<br>(Reapproved 2015) | | Same | Test Methodology | Purpose | Acceptance Criteria | Results | |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|---------------------------------------------------------------------------------|--------------------------|---------------------------------------------------------------------------------------------|-----------|-----------------------------------|
| Dimensions --Length<br>ILS-2 AQL4.0<br>(ASTMD 6319-10) | ≥230mm min | | 232 mm min for all sizes | | Similar | ASTM D 6319-<br>06(Reapproved<br>2015). | Dimension | Length | ≥230mm | |
| Dimensions<br>-- Width<br>IL S-2 AQL4.0<br>(ASTM D6319-10) | Small | 70-90 mm | Small | 76-90 mm | Similar | | | Width | Small | 76-90 mm |
| | Medium | 85-105mm | Medium | 87-102 mm | | | | | Medium | 87-102 mm |
| | Large | 100-120mm | Large | 108-119mm | | | | | Large | 108-119mm |
| | X large | 110-130 mm | X large | 115-128 mm | | | | | X large | 115-128 mm |
| Dimensions<br>--Thickness<br>IL S-2 AQL4.0<br>(ASTM D6319-10) | Finger 0.05mm min.<br>Palm 0.05mm min. | | | Thickness (mm) min.<br>Finger 0.08<br>Palm 0.08 | Similar | | | Thickness | Fingertip | ≥0.08mm |
| Physical Properties<br>IL S-2 AQL4.0<br>(ASTM D D6319-10) | Before aging/after aging Tensile<br>Strength≥ 14MPa<br><br>Before aging Elongation ≥500%<br>After aging Elongation ≥400% | | | Before Aging Elongation (%):<br>550-610<br>After Aging Elongation (%):<br>450-570<br><br>Before Aging Tensile Strength<br>(MPa): 18-25<br>After Aging Tensile Strength<br>(MPa): 17-22 | Similar | | | | Palm | ≥0.08mm |
| Freedom from<br>Pinholes | Meets<br>• 21 CFR 800.20<br>• ASTM D6319-10 | | | 1) Inspection Level I AQL2.5, and<br>Accept/Reject criteria of 10/11<br>2) Water leakage test: 5<br>noncompliance is allowed. | Similar | ASTM D 6319-<br>06(Reapproved<br>2015). | Physical<br>Properties | Tensile strength<br>(Before & After<br>aging) | ≥14MPa | 17-25 |
| Inspection<br>Level<br>AQL2.5 | I | | | | | | | Before aging Elongation | ≥500% | 550-610 |
| Residual Powder<br>(ASTM D 6124-<br>06(Reaffirmation<br>2011)) | below 2mg of residual<br>powder | | 1) Checked on 5pcs<br>sub-samples (N=5).<br>2) Result as following:<br>Mean: 0.1mg/pcs | | Similar | | | After aging Elongation | ≥400% | 450-570 |
| Materials used to<br>fabricate the devices | Nitrile | | | Nitrile | Same | • 21 CFR 800.20<br>• ASTM D 6319-<br>06(Reapproved<br>2015).<br>• ASTM D5151-19 | Freedom<br>from pinholes | Water leakage test:<br>Inspection Level I, AQL2.5, and<br>Accept/Reject criteria of 10/11. | | 5<br>noncompliance<br>is allowed. |
| Single Patient Use | Single Patient Use | | | Single Patient Use | Same | • ASTM D6319-<br>10(Reapproved<br>2015) | Powder<br>Residual | Meets<br><2mg/glove | | Mean:<br>0.1mg/pcs |
| Biocompatibility | Under the conditions of this study,<br>the test article was a non- irritant or<br>non- sensitizer (ISO 10993-<br>10:2002/Amd.1:<br>2006)<br>N/A<br>N/A | | | Under the conditions of this study,<br>the test article was a non- irritant or<br>non- sensitizer (ISO 10993-10:<br>Third Edition 2010-08-01)<br><br>Cytotoxicity study meets ISO 10993-<br>5 Third edition 2009-06-01<br><br>Under the conditions of study, the<br>device extracts do not pose a<br>systemic toxicity concern (ISO<br>10993-11:2017) | Similar<br><br>Different<br><br>Different | • ASTM D6124-06<br>(Reapproved<br>2017), | | | | Pass |
| Labeling | -Powder Free<br>-Patient Examination<br>Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot<br>-Blue color<br>- Non sterile | | | -Powder Free<br>-Patient Examination Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot<br>-Blue color<br>- Non sterile | Same | Primary Skin<br>Irritation in rabbits<br>ISO 10993-10: 2010-<br>08-01 | Biocompatibility | Under the conditions of the study,<br>the subject device is not a<br>primary skin irritant. | | Passes |
| Dermal sensitization<br>in the guinea pig ISO<br>10993-10: 2010-08-<br>01 | | Under the conditions of the study,<br>the subject device is not a skin<br>sensitizer. | | Passes | | | | | | |

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## 7.0 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 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

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.

ASTM D6319-10(Reapproved 2015), Standard Specification for Nitrile Examination Gloves for Medical Application.

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| The test article was<br>added to L929 cells<br>measured by MTT<br>assay ISO 10993-5:<br>2009 | Under the conditions of this<br>study, the test article was non-<br>cytotoxicity to L-929 cells. | Under the<br>conditions of the<br>study, cytotoxic.<br>Additional<br>testing was<br>performed to<br>determine if this<br>was a systemic<br>toxicity concern. |
|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| | | |
| | | |
| | | |
| Acute Systemic<br>Toxicity Systemic<br>injection in mice<br>ISO 10993-11:2017 | Under the conditions of study<br>the device extracts do not pose a<br>systemic toxicity concern | |
| | | |
| | | |

# 8.0 Discussion of Clinical and Performance Testing

Clinical testing is not needed for this device.

## 9.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.