Synthetic Vinyl Examination Gloves

K212002 · Yunnan Huazhiyuan Medical Technology Co., Ltd. · LYZ · Sep 23, 2021 · General Hospital

Device Facts

• Record ID: K212002
• Device Name: Synthetic Vinyl Examination Gloves
• Applicant: Yunnan Huazhiyuan Medical Technology Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Sep 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Story

Synthetic vinyl examination gloves; disposable; non-sterile; ambidextrous; blue color. Used by healthcare professionals in clinical settings to provide a protective barrier between examiner and patient. Device functions as a physical barrier to prevent contamination. Manufactured using poly vinyl chloride, polyurethane, nitrile, and DOTP. Performance verified against ASTM standards for physical dimensions, tensile strength, elongation, and freedom from holes. No electronic or software components.

Clinical Evidence

Bench testing only. No clinical data. Testing included physical dimensions (ASTM D5250), watertightness/hole detection (ASTM D5151, AQL 2.5), residual powder (ASTM D6124, <2.0mg), tensile strength/elongation (ASTM D412, before/after aging), and biocompatibility (ISO 10993-5 cytotoxicity, ISO 10993-10 irritation and sensitization). All tests met acceptance criteria.

Technological Characteristics

Materials: Poly vinyl chloride, polyurethane, nitrile, DOTP. Form factor: Ambidextrous, blue, non-sterile, powder-free. Standards: ASTM D5250 (PVC gloves), ASTM D5151 (hole detection), ASTM D6124 (residual powder), ASTM D412 (physical properties). Biocompatibility: ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between patient and examiner. Suitable for general patient examination settings.

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

• Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue (K153028)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. Food & Drug Administration" in blue text.

September 23, 2021

Yunnan Huazhiyuan Medical Technology Co., Ltd. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China

Re: K212002

Trade/Device Name: Synthetic Vinyl Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: June 21, 2021 Received: June 28, 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.

{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 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,

# Liqun Zha

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 Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known) K212002

Device Name Synthetic Vinyl Examination Gloves

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers 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 (K212002)

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

#### 1.0 Submitter's Information

Name: Yunnan Huazhiyuan Medical Technology Co., Ltd. Address: Yangjie Industrial Park,Jianshui County,Honghe Hani and Yi Autonomous Prefecture, Yunnan Province, 654300 China Phone Number: [phone] Fax Number: [phone] Contact: Yun Gao Date of Preparation: Aug.31,2021

#### Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: [phone] Email: [e-mail]

#### 2.0 Device Information

Trade name: Synthetic Vinyl Examination Gloves Common name: Vinyl Patient Examination Glove Classification name: Non-powdered Patient Examination Glove Model(s): XS、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: Zibo Huiying Medical Products, Co. Ltd. Trade/Device Name: Synthetic Patient Examination Vinyl Gloves,Powder

{4}------------------------------------------------

Free,Blue

510(k) number: K153028

#### 5.0 Indication for Use

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.

#### 6.0 Device Description

The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. 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 Characteristic Comparison Table

| Table1-General Comparison | | | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Item | Subject device | Predicate device | Comparison |
| 510(k) number | K212002 | K153028 | Different |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | A patient examination glove<br>is a disposable device<br>intended for medical<br>purposes that is worn upon<br>the examiner's hands or<br>fingers to prevent<br>contamination between<br>patient and examiner. | A patient examination glove<br>is a disposable device<br>intended for medical<br>purposes that is worn upon<br>the examiner's hands or<br>fingers to prevent<br>contamination between<br>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,<br>device color, device name,<br>glove size and quantity,<br>product name. Non-Sterile | Single use, powder free,<br>device color, device name,<br>glove size and quantity,<br>product name. Non-Sterile | Similar |

#### Table1-General Comparison

#### Table2 Device Dimensions Comparison

| Predicate<br>Device(K153028) | Designation | Size | Tolerance |
|------------------------------|-------------|----------------------------|-----------|
| | Length, mm | Average over 234 on M size | - |
| | Width, mm | Average over 96 on M size | - |

{5}------------------------------------------------

| | Thickness, mm: | | | | | | |
|-----------------------------|----------------|---------------|-----|-----------|-----|-----|-----|
| | Finger | Average 0.096 | - | | | | |
| | Palm | Average 0.098 | - | | | | |
| Subject Device<br>(K212002) | Designation | Size | | Tolerance | | | |
| | | XS | S | M | L | XL | |
| | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
| | Width, mm | 75 | 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, so the differences do not raise any new safety or performance questions.

| Item | Subject device | Predicate device | Comparison | |
|------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|----------------------|-----------|
| Colorant | Blue | Blue | Same | |
| Physical<br>Properties | Before Aging<br>Tensile Strength | 11MPa, min | Average 16.9MPa | Different |
| | Ultimate<br>Elongation | 300%min | Average 550% | Different |
| | After Aging<br>Tensile Strength | 11MPa, min | Average 14.4MPa, min | Different |
| | Ultimate<br>Elongation | 300%min | Average 550% | Different |
| | Comply with ASTM D5250 | Comply with ASTM D5250 | Same | |
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Same | |
| Powder Content | 0.12 mg per glove. Meet the requirements of ASTM D6124 | Meet the requirements of 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, so the differences do not raise any new safety or performance questions.

#### Table4 Safety Comparison

{6}------------------------------------------------

| Item | Subject device | Predicate device | Comparison | |
|--------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------|-----------|
| Material | Poly Vinyl Chloride<br>Polyurethane<br>Nitrile<br>Di-(2-ethylhexyl)<br>Terephthalate(DOTP) | Poly Vinyl Chloride<br>Polyurethane<br>Diisononyl<br>Phthalate<br>(DINP) | Similar | |
| Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | Same |
| | Sensitization | Under conditions of the study, not a sensitizer. | | |
| | Cytotoxicity | Under conditions of the study, did not show potential toxicity to L-929 cells. | Not provided | Different |
| Label and Labeling | Meet FDA's<br>Requirement | Meet FDA's Requirement | Same | |

Analysis: The materials of the subject device are little different with that of the predicate, but they all meet the performance requirements of ASTM D5250, also biocompatibility test has been performed on subject device and the test result can meet the requirements of ISO 10993 standards. Therefore, the differences will not raise any safety and effectiveness issues.

#### 8.0 Discussion 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

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

ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

| Test | Purpose | Acceptance Criteria | Results |
|------|---------|---------------------|---------|
|------|---------|---------------------|---------|

{7}------------------------------------------------

| Methodology | | | | | |
|--------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------|--------------------------------------------------------------------------------------------|--------------|
| ASTM D5250 | Physical<br>Dimensions<br>Test | Length(mm): $\geq$ 230; | Length: $\geq$ 230/ Pass | | |
| | | Width(mm): | Width: | | |
| | | XS:75±5; | XS: 78-79/ Pass | | |
| | | S: 85±5; | S: 87-88/Pass | | |
| | | M: 95±5; | M: 95-98/Pass | | |
| | | L: 105±5; | L: 103-107/Pass | | |
| | | XL: 115±5; | XL: 116-117/Pass | | |
| | | Thickness (mm): | | | |
| | | Finger: $\geq$ 0.08 | Finger: 0.08-0.09/Pass | | |
| | | Palm: $\geq$ 0.08 | Palm: 0.10/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 | | |
| 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 | 0.12 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 | $\geq$ 11MPa | 13-17/Pass |
| | | | Ultimate<br>Elongation | $\geq$ 300% | 370-495/Pass |
| | | After Aging | Tensile<br>Strength | $\geq$ 11MPa | 12-16/Pass |
| | | | Ultimate<br>Elongation | $\geq$ 300% | 370-445/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 | |

#### 9.0 Clinical Test Conclusion

{8}------------------------------------------------

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 in K153028.