Vinyl Examination Gloves(Yellow)
Device Facts
| Record ID | K211698 |
|---|---|
| Device Name | Vinyl Examination Gloves(Yellow) |
| Applicant | Liuping Trading Co., Ltd. |
| Product Code | LYZ · General Hospital |
| Decision Date | Oct 24, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for Use
The Vinyl Examination Gloves(Yellow) are disposable device intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
Device Story
Disposable, non-sterile, ambidextrous vinyl examination gloves; yellow color; worn by healthcare examiners to prevent cross-contamination between patient and examiner. Device functions as a physical barrier. Used in clinical settings. No electronic components or software.
Clinical Evidence
Bench testing only. No clinical data. Compliance demonstrated via ASTM D5250-19 (physical dimensions, tensile strength, elongation), ASTM D5151-19 (watertightness/holes), ASTM D6124-06 (residual powder), ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation and sensitization).
Technological Characteristics
Material: Vinyl (polyvinyl chloride). Non-sterile. Ambidextrous. Powder-free. Complies with ASTM D5250-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-5, and ISO 10993-10. No energy source or connectivity.
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
- Vinyl Patient Examination Gloves (White, Blue, Yellow) (K163168)
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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
October 24, 2021
Liuping Trading CO.,LTD. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai. 200120 China
Re: K211698
Trade/Device Name: Vinyl Examination Gloves(Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: September 17, 2021 Received: September 23, 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.
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 (1-800-638-2041 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) K211698
Device Name Vinyl Examination Gloves(Yellow)
Indications for Use (Describe)
The Vinyl Examination Gloves(Yellow) are disposable device intended for medical purposes that are 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
# (K211698)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
#### 1.0 Submitter's Information
Name: LIUPING TRADING CO.,LTD. Address: Xingtong Town, Linyi County, Dezhou City 251500, Shandong, China. Phone Number: Contact: Jing Li Date of Preparation: 09/17/2021
### Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
#### 2.0 Device Information
Trade name: Vinyl Examination Gloves (Yellow) Common name: Vinyl Patient Examination Glove Classification name: Non-powdered Patient Examination Glove Model(s): S, M, L, XL
#### 3.0 Classification
Production code: LYZ Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
#### 4.0 Predicate Device Information
Manufacturer: Hebei Hongtai Plastic Products Company Limited Device: Vinyl Patient Examination Gloves (White, Blue, Yellow) 510(k) number: K163168
#### 5.0 Indication for Use
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The Vinyl Examination Gloves(Yellow) 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 vinyl patient examination gloves. The subject device is yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
#### 7.0 Technological Characteristics Comparison Table With The Predicate Device
| Item | Subject device | Predicate device | Comparison |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) number | K211698 | K163168 | / |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Vinyl Examination Gloves (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | The Vinyl Examination Glove (White, Blue, or Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | Same |
| Powdered or<br>Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Labeling<br>Information | Single use, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile | Single use, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile | Similar |
#### Table1-General Comparison
#### Table2 Device Dimensions Comparison
| Predicate<br>Device(K163168) | Designation | Size | | | | | Tolerance |
|------------------------------|----------------|-----------|----------|----------|----------|-----------|-----------|
| | Length, mm | XS<br>230 | S<br>230 | M<br>235 | L<br>245 | XL<br>245 | min |
| | Width, mm | 80 | 85 | 95 | 105 | 115 | $\pm 5$ |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | | min |
| | Palm | 0.08 | | | | | min |
| Subject Device | Designation | Size | | | | | Tolerance |
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| (K211698) | | S | M | L | XL | |
|-----------|----------------|------|-----|-----|-----|-----|
| | Length, mm | 230 | 230 | 230 | 230 | min |
| | Width, mm | 85 | 95 | 105 | 115 | ±5 |
| | Thickness, mm: | | | | | |
| | Finger | 0.08 | | | | min |
| | Palm | 0.08 | | | | min |
| Remark | Similar | | | | | |
Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D5250-19.
| Item | | Subject device<br>K211698 | Predicate device<br>K163168 | Comparison | |
|------------------------|------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------|
| Colorant | | Yellow | White, Blue, Yellow | Same | |
| Physical<br>Properties | Before<br>Aging | Tensile<br>Strength<br>11MPa, min | 15MPa, min | Different | |
| | | Ultimate<br>Elongation<br>300%min | 380%min | Different | |
| | After<br>Aging | Tensile<br>Strength<br>11MPa, min | 15MPa, min | Different | |
| | | Ultimate<br>Elongation<br>300%min | 380%min | Different | |
| | Comply with ASTM D5250 | | Comply with ASTM D5250 | Same | |
| Freedom from Holes | | | Be free from holes<br>when tested in<br>accordance with<br>ASTM D5151<br>AQL=2.5 | Be free from holes<br>when tested in<br>accordance with<br>ASTM D5151<br>AQL=2.5 | Same |
| Powder Content | | Meet the<br>requirements of<br>ASTM D6124 <2<br>mg per glove. | Meet the<br>requirements of<br>ASTM D6124 | Similar | |
### Table3 Performance Comparison
Analysis: The tensile strength and ultimate elongation are different with that of the predicate, but they all meet the requirements of ASTM D5250
| Item | Subject device<br>K211698 | Predicated device<br>K163168 | Comparison | |
|------------------|---------------------------|----------------------------------------------------------|----------------------------|------|
| Material | Vinyl | Vinyl | Same | |
| Biocompatibility | Irritation | Under the<br>conditions of the<br>study, not an irritant | Comply with<br>ISO10993-10 | Same |
| | Sensitization | Under conditions of | | |
#### Table4 Safety Comparison
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| | | the study, not a<br>sensitizer. | | |
|--------------------|--------------|----------------------------------------------------------------------------------------------|---------------------------|---------|
| | Cytotoxicity | Under conditions of /<br>the study, did not<br>show potential<br>toxicity to L-929<br>cells. | | Similar |
| Label and Labeling | | Meet FDA's<br>Requirement | Meet FDA's<br>Requirement | Same |
### 8.0 Summarv of Non-Clinical 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
ASTMD5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
| Test<br>Methodology | Purpose | Acceptance Criteria | Results |
|---------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| ASTM D5250 | Physical<br>Dimensions<br>Test | Length(mm):≥230; | Length:> 230/ Pass |
| | | Width(mm):<br>S: 85±5;<br>M: 95±5;<br>L: 105±5;<br>XL: 115±5;<br>Thickness (mm):<br>Finger: ≥0.08<br>Palm: ≥0.08 | Width:<br>S: 84-85/Pass<br>M: 94-96/Pass<br>L: 104-106/Pass<br>XL: 113-115/Pass<br>Finger: 0.12~0.13/Pass<br>Palm: 0.08/Pass |
| ASTM D5151 | Watertightness<br>Test for<br>Detection of<br>Holes | Meet the requirements of ASTM D5151<br>AQL 2.5 | 0/125 leaks / Pass |
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| ASTM D6124 | Powder<br>Content<br>(Medium glove<br>is the<br>representative<br>sample of the<br>product) | Meet the requirements of ASTM D6124<br>< 2.0mg | 0.19 mg/Pass; | | |
|------------|--------------------------------------------------------------------------------------------------|------------------------------------------------|------------------------|-----------------|--------------------------------------------------------------------------------------------|
| ASTM D412 | Physical<br>properties<br>(Medium glove<br>is the<br>representative<br>sample of the<br>product) | Before<br>Aging | Tensile<br>Strength | ≥11MPa | 13-18/Pass |
| | | | Ultimate<br>Elongation | ≥300% | 300-340/Pass |
| | | After Aging | Tensile<br>Strength | ≥11MPa | 14-18/Pass |
| | | | Ultimate<br>Elongation | ≥300% | 300-320/Pass |
| | | ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the<br>study, did not show potential<br>toxicity to L-929 cells./ Pass |
| | | ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the<br>study, not an irritant/ Pass |
| | | ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the<br>study, not a sensitizer./ Pass |
## 9.0 Summary of Clinical Testing
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 under K163168.
