K Number
K210821
Device Name
Medical PVC Examination Gloves
Date Cleared
2021-07-09

(112 days)

Product Code
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 Description
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.
More Information

Not Found

No
The device description and performance studies focus on the physical properties and safety of examination gloves, with no mention of AI or ML.

No
The device, "Medical PVC Examination Gloves," is described as a disposable barrier device to prevent contamination, not to treat or cure a medical condition. Its function is protective.

No

Explanation: The device, Medical PVC Examination Gloves, is described as a disposable device intended to prevent contamination between patient and examiner. Its purpose is to act as a barrier, not to diagnose any condition or disease.

No

The device is a physical product (gloves) made of vinyl chloride, not software. The description focuses on material properties and physical standards.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The intended use is clearly stated as "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on samples taken from the body.
  • Device Description: The description focuses on the physical properties and materials of the gloves, and their purpose as a barrier. There is no mention of analyzing biological samples or providing diagnostic information.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing blood, urine, tissue, or other biological samples.
    • Detecting or measuring specific substances (analytes).
    • Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
    • Using reagents or other components typically associated with diagnostic tests.

The device is a medical glove, which is a Class I or Class II medical device depending on its intended use and risk, but it falls under the category of personal protective equipment and barrier devices, not in vitro diagnostics.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

LYZ

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K182043

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

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 (1-800-638-2041 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
    1. 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: +86-18970093059 Fax: +86-791-85628888 Email: zkb(@jxhd.cn

    1. 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: +86-18910677558 Fax: +86-10-56335780 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.

DesignationSizeTolerance
XSSMLXL
Length, mm230230230230230min
Width, mm808595105115±5
Thickness, mm:
Finger0.08min
Palm0.08min
Cuff0.08min

Table 1 Device Size Specifications

Table 2 Performance and Physical Specifications

Before AgingAfter AgingPinhole AQL
Tensile
StrengthUltimate
ElongationTensile
StrengthUltimate
Elongation2.5
11 MPa, min300 % min11 MPa, min300 % 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
Medical PVC Examination Gloves | Predicate Device (K182043)
Single-use medical poly (vinyl chloride)
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
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. | 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
Powder free | Powder free | Powder free | SAME |

Table 1 General Comparison

6

SizeTolerance
DesignationXSSMLXL
Proposed DeviceLength, mm230230230230230min
Width, mm808595105115$\pm$ 5
Thickness, mm:
Finger0.08min
Palm0.08min
SizeTolerance
DesignationXSSMLXL
Predicate Device ((K182043)Length, mm240240240240240min
Width, mm808595105115$\pm$ 5
Thickness, mm:
Finger0.07min
Palm0.08min
RemarkDifferent (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
Medical PVC Examination Gloves | Predicate Device (K182043)
Single-use medical poly (vinyl
chloride) examination glove (Clear,
Non-Colored) | Remark |
|------------------------|-----------------|------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------|
| Colorant | | | Clear, Non-Colored | Clear, Non-Colored | SAME |
| Physical
Properties | Before
Aging | Tensile
Strength | 11 MPa, min | 15 MPa, min | Different
(Analysis 2) |
| | | Ultimate
Elongation | 300 % min | 350 % min | |
| | After
Aging | Tensile
Strength | 11 MPa, min | 15 MPa, min | |
| | | Ultimate
Elongation | 300 % min | 350 % min | |
| Freedom from Holes | | | Be free from holes when tested in
accordance with ASTM D5151 | Be free from holes when tested in
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 D6124tested 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
Medical PVC Examination Gloves | Predicate Device (K182043)
Single-use medical poly (vinyl
chloride) examination glove
(Clear, Non-Colored) | Remark | |
|--------------------|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|---------------------------|
| Material | Vinyl chloride | Vinyl chloride | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study
(ISO 10993-10), not an irritant | Under the conditions of the
study, not an irritant | SAME |
| | Sensitization | Under conditions of the study (ISO
10993-10), not a sensitizer. | Under conditions of the study,
not a sensitizer. | SAME |
| | Acute
Systemic
Toxicity | Under the condition of the study
(ISO 10993-11), there is no mortality
or evidence of systemic toxicity | / | Different
(Analysis 3) |
| | Cytotoxicity | Data not available | Comply with ISO 10993-5 | Different
(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

    1. 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.