Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Device Facts
| Record ID | K211865 |
|---|---|
| Device Name | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
| Applicant | Liao Ning Shangwei Medical Products Co., Ltd. |
| Product Code | LYZ · General Hospital |
| Decision Date | Dec 20, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for Use
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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
Disposable medical PVC examination gloves; non-sterile; clear (non-colored). Device acts as physical barrier; worn on examiner's hand or finger during medical procedures to prevent contamination between patient and examiner. Manufactured from PVC compound. Conforms to hand to allow movement. Used in clinical settings by healthcare providers. Benefits patient by reducing risk of cross-contamination.
Clinical Evidence
No clinical data. Bench testing only. Testing included dimensions, physical properties (tensile strength, elongation), freedom from pinholes (ASTM D5151-19), residual powder (ASTM D6124-06), and biocompatibility (ISO 10993-5, ISO 10993-10). All tests met acceptance criteria.
Technological Characteristics
Material: Poly Vinyl Chloride (PVC) rubber. Form factor: Disposable, non-sterile, powder-free gloves. Dimensions: Length ≥230mm; thickness ≥0.05mm (fingertip), ≥0.08mm (palm). Standards: ASTM D5250-06 (Reapproved 2015), ASTM D5151-19, ASTM D6124-06 (Reapproved 2017), ISO 10993-5, ISO 10993-10. Mechanical barrier principle.
Indications for Use
Indicated for use as a disposable medical device 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 Vinyl Patient Examination Gloves, Clear (non-colored) (K091663)
Submission Summary (Full Text)
{0}------------------------------------------------
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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
December 20, 2021
Liao Ning 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,Chaoyang District Beijing, 100121 China
Re: K211865
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: October 18, 2021 Received: December 17, 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.
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K211865
Device Name
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
| 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)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
# 510(K) Summary
.............................................................................................................................................................................. "The assigned 510(k) number is: K211865
### Premarket Notification [510(k)] Summary
#### 1.0 Submitter:
| Submitter's name : | Liao Ning Shangwei Medical Products<br>Co.,Ltd. | | | | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Submitter's address : | No.210 Management Committee<br>Office,Economic Development<br>Zone,Diaobingshan City,Tieling City,Liaoning<br>Province,112700,P.R. China | | | | |
| Phone number : | 0086-024-76518888<br>0086-024-76518888 | | | | |
| Name of contact person: | Mr. Zhu Hongqing | | | | |
| Date of preparation : | 2021-10-18 | | | | |
#### 2.0 Name of the Device
| Device Name: | Powder Free Vinyl Patient Examination<br>Gloves, Clear (non-colored) | |
|--------------------------|----------------------------------------------------------------------|--|
| Proprietary/ Trade name: | Powder Free Vinyl Patient Examination<br>Gloves, Clear (non-colored) | |
| Common Name: | Exam gloves | |
| Classification Name: | Patient examination glove | |
| Device Classifications: | I | |
| Regulation Number: | 21 CFR 880.6250 | |
| Panel: | General Hospital | |
| Product Code: | LYZ | |
### 3.0 Predicate device
| Device Name: | Powder Free Vinyl Patient Examination Gloves,<br>Clear (non-colored) |
|----------------|----------------------------------------------------------------------|
| Company name: | Zhang Jia Gang Fengyuan Plastic Product Co. Ltd |
| 510(K) Number: | K091663 |
## 4.0 Device Description:
The subject device is disposable medical PVC gloves that made from PVC compound, Clear (non-colored), powder free and nonsterile.
The device meets the specifications in ASTM D5250-06(Reapproved 2015) Standard specification for poly (vinyl chloride) gloves for medical application.
{4}------------------------------------------------
### 5.0 Indications for Use Statement:
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
## 6.0 Summary of the Technological Characteristics of the Device:
The Poly (vinyl chloride) glove made of Poly Vinyl Chloride (PVC) rubber. The PVC film is water tight under normal conditions of use and its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure, so PVC glove can form a barrier to prevent contamination between patient and examiner worn them on his hand or finger.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimension | ASTM D 5250-06(Reapproved 2015). |
| | Length ≥230mm |
| | Width<br>Small 80-90 mm<br>Medium 90-100mm<br>Large 100-110mm<br>X large 110-120 mm |
| | Thickness<br>Fingertip ≥0.05mm<br>Palm ≥0.08mm |
| | |
| Physical<br>Properties | ASTM D 5250-06(Reapproved 2015). |
| | Tensile strength (Before & After aging) ≥11MPa |
| | Elongated rate (Before & After aging) ≥300% |
| Freedom from<br>pinholes | 21 CFR 800.20 Passed Standard Acceptance Criteria ASTM D5250-06(Reapproved 2015) ASTM D5151-19 |
| Powder Residual | ASTM standard D 5250-06<br>(Reapproved 2015).and<br>D6124-06(Reapproved 2017) Meets<br><2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits Passes<br>ISO 10993-10: 2010-08-01 Under the conditions<br>of the study, the<br>subject device is not<br>a primary skin<br>irritant. |
| | Dermal sensitization in the guinea pig Passes<br>ISO 10993-10: 2010-08-01 Under the conditions<br>of the study, the<br>subject device is not<br>a skin sensitizer. |
| | The test article was added to L929 Pass<br>cells measured by MTT assay Under the conditions<br>ISO 10993-5: 2009 of this study, the test<br>article was<br>non-cytotoxicity to |
{5}------------------------------------------------
# 7.0 Technological Characteristic Comparison:
| Features & Description | Predicate Device | Subject Device | Result of Comparison | |
|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|---------|
| Company | Zhang Jia Gang Fengyuan Product Co. Ltd. | Liao Ning Shangwei Medical Products Co.,Ltd. | -- | |
| 510(K) Number | K091663 | K211865 | -- | |
| Product name | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Same | |
| Product Code | LYZ | LYZ | Same | |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large | Same | |
| Intend for use | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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. | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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. | Same | |
| Device Description and Specifications | Meets ASTM D5250-06 | Meets ASTM D5250-06 (Reapproved 2015) | Similar | |
| Dimensions Length (mm) ILS-2 AQL4.0 | ≥230mm | 231-241mm | 233-241mm | Similar |
| Dimensions Width (mm) IL S-2 AQL4.0 | Small 80-90 | 81-89 | 81-89 | Similar |
| | Medium 90-100 | 93-99 | 92-99 | |
| | Large 100-110 | 102-110 | 102-109 | |
| | X large 110-120 | 111-119 | 112-119 | |
| Dimensions Thickness (mm) IL S-2 AQL4.0 | Finger ≥0.05 | 0.05-0.10 | 0.09-0.11 | Similar |
| (mm) IL S-2 AQL4.0 Palm | ≥0.08 | 0.09-0.13 | 0.10-0.11 | Similar |
| Before aging/after aging | | | | |
| Physical Properties IL S-2 AQL4.0 | Elongation ≥300% | 380-410% | 350-420% | Similar |
| | Tensile Strength ≥ 14MPa | 16-20 MPa | 16-22 MPa | |
| Freedom from Pinhole S | Holes at Inspection Level I AQL2.5 | Holes at Inspection Level I AQL2.5 | Holes at Inspection Level I AQL2.5 | Similar |
| Residual Powder | below 2mg of residual powder | 0.3mg | 0.1mg | Similar |
| Materials used to<br>fabricate the devices | PVC | PVC | Same | |
| Compare performance<br>data supporting<br>substantial equivalence | Meets<br>ASTM D5151-06<br>(Reapproved 2011)<br>ASTM D5250-06<br>(Reapproved 2011)<br>ASTM D6124-06<br>(Reaffirmation 2011) | Meets<br>ASTM D5151-19<br>ASTM D5250-06<br>(Reapproved 2015)<br>ASTM D6124-06<br>(Reapproved 2017) | Similar | |
| Single Patient Use | Single Patient Use | Single Patient Use | Same | |
| Biocompatibility | Under the conditions<br>of this study, not an<br>irritant and Under the<br>conditions of this<br>study, not a sensitizer.<br><br>SKIN IRRITATION<br>DERMAL and<br>SENSITIZATION<br>STUDIES Meets ISO<br>10993-10:2002/Amd.1:<br>2006 | Under the conditions<br>of this study, not an<br>irritant and Under the<br>conditions of this<br>study, not a sensitizer.<br><br>SKIN IRRITATION<br>DERMAL and<br>SENSITIZATION<br>STUDIES Meets ISO<br>10993-10 Third<br>Edition 2010-08-01<br><br>Under the conditions<br>of this study, the test<br>article was<br>non-cytotoxicity to<br>L-929 cells. | Same | |
| Labeling for the legally<br>marketed device to which<br>substantial equivalence is<br>claimed. | -Powder Free<br>-Patient Examination<br>Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot | -Powder Free<br>-Patient Examination<br>Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot | Same | |
{6}------------------------------------------------
For all above differences (state "similar" in the right column on above table) between the subject and predicate devices, they are derived from individual product differentiation, those differences are not critical to the intended use and the differences do not affect the safety and effectiveness of the subject device when used as labeled, due to each items belonged to the product performance are within the range of the standard requirement (ASTM D6319-10) at that time.
### 8.0 Summary of Non-Clinical Performance Data:
Non-clinical tests were conducted to verify that the proposed device will meet acceptance criteria for each test. The test results demonstrated that the proposed device met the acceptance criteria found in the following standards below:
| ISO 10993-5:2009 | Biological Evaluation of Medical Devices - Part 5: Tests<br>For In Vitro Cytotoxicity |
|------------------------------------|-----------------------------------------------------------------------------------------------------|
| ISO 10993-10:2010 | Biological Evaluation of Medical Devices - Part 10: Tests<br>For Irritation And Skin Sensitization. |
| ASTM D5151-19 | Standard Test Method for Detection of Holes in Medical<br>Gloves. |
| ASTM D5250-06<br>(Reapproved 2015) | Standard specification for poly (vinyl chloride) gloves for<br>medical application. |
{7}------------------------------------------------
| ASTM D6124-06<br>(Reapproved 2017) | Standard Test Method for Residual Powder on Medical<br>Gloves |
|------------------------------------|---------------------------------------------------------------|
|------------------------------------|---------------------------------------------------------------|
## Summary of the non-clinical testing is shown as below:
| Test Methodology | Purpose | Acceptance Criteria | Results |
|----------------------------------------------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------|
| ASTM D5250-06<br>(Reapproved 2015) | Dimension<br>(mm)<br>IL S-2<br>AQL4.0 | Length $\geq$ 230 | 233-241 |
| | | Width<br>Small 80-90 | 81-89 |
| | | Medium 90-100 | 92-99 |
| | | Large 100-110 | 102-109 |
| | | X large 110-120 | 112-119 |
| | Thickness<br>Fingertip $\geq$ 0.05<br>Palm $\geq$ 0.08 | 0.09-0.11<br>0.10-0.11 | |
| ASTM D5250-06<br>(Reapproved 2015) | Physical<br>Properties<br>IL S-2<br>AQL4.0 | (Before & After aging) | |
| | | Tensile<br>strength $\geq$ 14MPa | 17-25 |
| | | Before<br>aging<br>Elongation $\geq$ 500%<br>After aging<br>Elongation $\geq$ 400% | 560-610<br>460-570 |
| 21 CFR 800.20<br>•<br>ASTM D5250-06<br>•<br>(Reapproved 2015)<br>ASTM D5151-19<br>• | Freedom from<br>pinholes | Waterleakage test:<br>Inspection Level I, AQL2.5, and<br>Accept/Reject criteria of 10/11. | 5noncompliance<br>is allowed. |
| | | | Pass |
| ASTM<br>•<br>D5250-06(Reapproved 2015)<br>ASTM D6124-06<br>•<br>(Reapproved<br>2017), | Powder Residual | Meets<br>$<$ 2mg/glove | Mean: 0.1mg/pcs<br>Pass |
| Primary Skin<br>Irritation in rabbits<br>ISO 10993-10:<br>2010-08-01 | Biocompatibility | Under the conditions of the study,<br>the subject device is not a primary<br>skin irritant. | Passes |
| Dermal sensitization<br>in the guinea pig ISO<br>10993-10: 2010-08-01 | | Under the conditions of the study,<br>the subject device is not a skin<br>sensitizer. | Passes |
| 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 study,<br>the test article was non-cytotoxicity<br>to L-929 cells. | Pass |
#### Summary of Clinical Performance Data: 9.0
Clinical testing is not needed for this device.
# 10.0 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.
