Medical PVC Examination Gloves

K210821 · Jiangxi Hongda Medical Equipment Group , Ltd. · LYZ · Jul 9, 2021 · General Hospital

Device Facts

• Record ID: K210821
• Device Name: Medical PVC Examination Gloves
• Applicant: Jiangxi Hongda Medical Equipment Group , Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jul 9, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

The Medical PVC Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Story

Medical PVC Examination Gloves are disposable, non-sterile, powder-free vinyl gloves. Used in clinical settings by healthcare examiners to provide a barrier against contamination between the examiner and the patient. The device is worn on the hands; it functions as a physical barrier. No electronic, software, or algorithmic components are involved. The device is manufactured from vinyl chloride and is designed to meet ASTM D5250 standards for physical dimensions and performance properties, including tensile strength and elongation. The gloves are intended for over-the-counter use.

Clinical Evidence

Bench testing only. Compliance with ASTM D5250 (physical properties), ASTM D5151 (freedom from holes), and ASTM D6124 (residual powder) was verified. Biocompatibility testing performed per ISO 10993-10 (irritation and sensitization) and ISO 10993-11 (acute systemic toxicity).

Technological Characteristics

Material: Vinyl chloride. Form factor: Disposable, powder-free, clear, non-colored gloves. Sizes: XS, S, M, L, XL. Thickness: 0.08 mm (min). Tensile strength: 11 MPa (min). Elongation: 300% (min). Standards: ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11. Non-sterile.

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

• Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) (K182043)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 9, 2021

Jiangxi Hongda Medical Equipment Group Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm 912, Building #15, XiYueHui, No.5, YiHe North Rd FangShan District Beijing, 102401 China

Re: K210821

Trade/Device Name: Medical PVC Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: April 9, 2021 Received: April 13, 2021

Dear Ray 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 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 [phone] or 301-796-7100).

Sincerely.

# Jiangsong Jiang -S (Affiliate)

For Ryan Ortega 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 Quality Center for Devices and Radiological Health

Enclosure

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

### Indications for Use

510(k) Number (if known) K210821

Device Name Medical PVC Examination Gloves

Indications for Use (Describe)

The Medical PVC Examination Gloves is a disposable device intended for medical purposes that is 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)

#### 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

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: K210821

- 1. Date of Preparation: 07/09/2021
- 2. Sponsor

#### Jiangxi Hongda Medical Equipment Group Ltd.

No. 39 South Shengli Road, Jinxian County, Nanchang City, JiangXi Province, 331700, China Contact Person: Yang Qinghua Position: Manager Tel: [phone] Fax: [phone] Email: zkb(@jxhd.cn

- 3. Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401

Tel: [phone] Fax: [phone] Email: ray.wang(@believe-med.com

- Proposed Device Identification 4.
Trade Name: Medical PVC Examination Gloves Common Name: Vinyl Patient Examination Gloves (Powder Free)

Regulatory Information: Classification: I Product Code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

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

Indication For Use Statement:

The Medical PVC Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

- Predicate Device Identification 5.
510(k) Number: K182043

Product Name: Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) Manufacturer: HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD

- Device Description 6.
The proposed device, Medical PVC Examination Gloves are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250.

The proposed device is not provided as sterilized

The proposed device is made of vinyl chloride.

| Designation | Size | | | | | Tolerance |
|----------------|------|-----|-----|-----|-----|-----------|
| | XS | S | M | L | XL | |
| Length, mm | 230 | 230 | 230 | 230 | 230 | min |
| Width, mm | 80 | 85 | 95 | 105 | 115 | ±5 |
| Thickness, mm: | | | | | | |
| Finger | 0.08 | | | | | min |
| Palm | 0.08 | | | | | min |
| Cuff | 0.08 | | | | | min |

#### Table 1 Device Size Specifications

Table 2 Performance and Physical Specifications

| Before Aging | | After Aging | | Pinhole AQL |
|---------------------|------------------------|---------------------|------------------------|-------------|
| Tensile<br>Strength | Ultimate<br>Elongation | Tensile<br>Strength | Ultimate<br>Elongation | 2.5 |
| 11 MPa, min | 300 % min | 11 MPa, min | 300 % min | |

The above data of size, performance, and physical specifications of proposed gloves meet all the

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

current specifications listed in the ASTM standard D5250.

#### 7. Substantially Equivalent Comparison Conclusion

| ITEM | Proposed Device<br>Medical PVC Examination Gloves | Predicate Device (K182043)<br>Single-use medical poly (vinyl chloride)<br>examination glove (Clear, Non-Colored) | Remark |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LYZ | LYZ | SAME |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME |
| Class | I | I | SAME |
| Indications For<br>Use | The Medical PVC Examination Gloves<br>is a disposable device intended for<br>medical purposes that is worn on the<br>examiner's hands to prevent contamination<br>between patient and examiner. | The Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) 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>Powder free | Powder free | Powder free | SAME |

#### Table 1 General Comparison

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

| | Size | | | | | Tolerance | |
|-----------------------------|------------------------|------|-----|-----|-----|-----------|---------|
| | Designation | XS | S | M | L | | XL |
| Proposed Device | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
| | Width, mm | 80 | 85 | 95 | 105 | 115 | $\pm$ 5 |
| | Thickness, mm: | | | | | | |
| | Finger | 0.08 | | | | | min |
| | Palm | 0.08 | | | | | min |
| | Size | | | | | Tolerance | |
| | Designation | XS | S | M | L | | XL |
| Predicate Device ((K182043) | Length, mm | 240 | 240 | 240 | 240 | 240 | min |
| | Width, mm | 80 | 85 | 95 | 105 | 115 | $\pm$ 5 |
| | Thickness, mm: | | | | | | |
| | Finger | 0.07 | | | | | min |
| | Palm | 0.08 | | | | | min |
| Remark | Different (Analysis 1) | | | | | | |

Table 2 Device Dimensions Comparison

Different Analysis 1:

The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D 5250.

So, this difference would not raise safety or effectiveness concerns.

| ITEM | | | Proposed Device<br>Medical PVC Examination Gloves | Predicate Device (K182043)<br>Single-use medical poly (vinyl<br>chloride) examination glove (Clear,<br>Non-Colored) | Remark |
|------------------------|-----------------|------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------|
| Colorant | | | Clear, Non-Colored | Clear, Non-Colored | SAME |
| Physical<br>Properties | Before<br>Aging | Tensile<br>Strength | 11 MPa, min | 15 MPa, min | Different<br>(Analysis 2) |
| | | Ultimate<br>Elongation | 300 % min | 350 % min | |
| | After<br>Aging | Tensile<br>Strength | 11 MPa, min | 15 MPa, min | |
| | | Ultimate<br>Elongation | 300 % min | 350 % min | |
| Freedom from Holes | | | Be free from holes when tested in<br>accordance with ASTM D5151 | Be free from holes when tested in<br>accordance with ASTM D5151 | SAME |
| Powder Content | | | Less than 2 mg per glove when tested | Less than 2 mg per glove when | SAME |

Table 3 Performance Comparison

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

| | in accordance with ASTM D6124 | tested in accordance with ASTM D6124 | |
|--|-------------------------------|--------------------------------------|--|
|--|-------------------------------|--------------------------------------|--|

Different Analysis 2:

The proposed device has different Tensile Strength before aging specification to the predicate device, but all proposed device meets the specification requirements of ASTM D 5250.

So, this difference would not raise safety or effectiveness concerns.

| ITEM | Proposed Device<br>Medical PVC Examination Gloves | Predicate Device (K182043)<br>Single-use medical poly (vinyl<br>chloride) examination glove<br>(Clear, Non-Colored) | Remark | |
|--------------------|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|---------------------------|
| Material | Vinyl chloride | Vinyl chloride | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study<br>(ISO 10993-10), not an irritant | Under the conditions of the<br>study, not an irritant | SAME |
| | Sensitization | Under conditions of the study (ISO<br>10993-10), not a sensitizer. | Under conditions of the study,<br>not a sensitizer. | SAME |
| | Acute<br>Systemic<br>Toxicity | Under the condition of the study<br>(ISO 10993-11), there is no mortality<br>or evidence of systemic toxicity | / | Different<br>(Analysis 3) |
| | Cytotoxicity | Data not available | Comply with ISO 10993-5 | Different<br>(Analysis 3) |
| Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | SAME | |

| | | Table 4 Safety Comparison |
|--|--|---------------------------|
| | | |

Analysis 3

The proposed device has conducted the testing of Acute Systemic Toxicity which is the predicate device did not, the testing results shown that the proposed device has no systemic toxicity.

### 8. Non-Clinical Test Conclusion

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

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

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

ASTM D6124-17, Standard Test Method for Residual Powder on Medical Gloves.

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.

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

- 9. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K210821, the Medical PVC Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device K182043.