Vinyl Examination Glove (Clear, Non-Colored)

• K Number: K180849
• Device Name: Vinyl Examination Glove (Clear, Non-Colored)
• Manufacturer: Huifu Trading Co., Ltd
• Date Cleared: 2018-06-11 ( 70 days)
• Product Code: LYZ
• Regulation Number: 880.6250

Intended Use

The Vinyl 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.

Device Description

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 non-sterile.

Predicate Devices

K163168

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard medical examination glove and does not mention any AI or ML capabilities.

Therapeutic

No.
The device, a Vinyl Examination Glove, is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.

Diagnostic

No

Explanation: The device is a vinyl examination glove the purpose of which is to prevent contamination between the patient and examiner. It does not diagnose any condition or disease.

SaMD (Software as a Medical Device)

No

The device description and performance studies clearly indicate a physical product (gloves) and not a software application.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
• Device Description: The description focuses on the physical properties and standards related to the glove's integrity and material, not on any diagnostic capabilities.
• Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing any information about a patient's health status.
• Performance Studies: The performance studies focus on the physical and biological safety of the glove (tensile strength, freedom from holes, biocompatibility), not on diagnostic accuracy.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Vinyl 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.

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

LYZ

Device Description

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 non-sterile.

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

medical purposes

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)

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 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves
• ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D5250-06 (Reapproved 2015), Standard Specification for Poly(vinyl chloride) Gloves for Medical Application.
• ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.

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

Tensile Strength Before Aging: 15 MPa, min
Ultimate Elongation Before Aging: 380 % min
Tensile Strength After Aging: 15 MPa, min
Ultimate Elongation After Aging: 380 % min
Freedom from Holes: Be free from holes when tested in accordance with ASTM D5151 AQL=1.5
Powder Content: 0.5 mg

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.

K163168

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

Regulation Number and Section

§ 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.

Summary

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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 consists of a stylized emblem. The FDA logo is on the right and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 11, 2018

Huifu Trading Co., 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: K180849

Trade/Device Name: Vinyl Examination Glove (Clear, Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: March 30, 2018 Received: April 2, 2018

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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K180849

Device Name

Vinyl Examination Glove (Clear, Non-Colored)

Indications for Use (Describe)

The Vinyl 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.

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

This 510(k) Summary is being submitted in accordance with Title 21, CFR Section 807.92.

The assigned 510(k) Number: K180849

• 1. Date of Preparation:2018/06/04
• 2. Sponsor Identification

HUIFU TRADING CO., LTD. NORTH, SHANGHAI ROAD, ZHANGDIAN DISTRICT, ZIBO CITY, CHINA 255000

Contact Person: Kangkang Wang Position:Sales Manager Tel: [phone] Fax: [phone]

Email: [e-mail]

• 3. Designated Submission Correspondent
     Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

Tel: [phone], Fax: [phone] Email: [e-mail]

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• 4. Identification of Proposed Device
     Trade Name: Vinyl Examination Glove (Clear, Non-Colored) Common Name: Vinyl Patient Examination Gloves (Powder Free) Model(s): S M L XL

Regulatory Information Classification Name: Vinyl Patient Examination Gloves (Powder Free) Classification:1 Product Code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

Indication for use Statement:

The Vinyl 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.

• Device Description న.
  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 non-sterile.

• Identification of Predicate Device(s) 6.
  Predicate Device K163168 Vinyl Patient Examination Gloves (White, Blue, Yellow) Hebei Hongtai Plastic Products Company Limited

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7.	Technological Comparison
----	--------------------------

ITEM	Proposed Device	Predicate Device (K163168)	Remark
Product Code	LYZ	LYZ	SAME
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	SAME
Class	I	I	SAME
Intended Use	The Vinyl Patient 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.	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.	SIMILAR
Powdered or
Powered free	Powdered free	Powdered free	SAME
Design Feature	ambidextrous	ambidextrous	SAME
Surface Feature	Smooth	Smooth	SAME
Labeling
Information	Single-use indication, powder free, device
color, device name, glove size and quantity,
Vinyl Examination Gloves, Non-Sterile	Single-use indication, powder free, device
color, device name, glove size and quantity,
Vinyl Examination Gloves, Non-Sterile	SAME

Table 1 General Comparison

Table 2 Device Dimensions Comparison

		Size
	Designation	XS	S	M	L	XL	Tolerance
	Length, mm	230	230	235	245	245	min
Predicate Device (K163168)	Width, mm	80	85	95	105	115	$\pm$ 5
	Thickness, mm:
	Finger	0.05					min
	Palm	0.08					min
		Size				Tolerance
	Designation	S	M	L	XL
	Length, mm	230	235	245	245		min
Proposed Device	Width, mm	85	95	105	115		$\pm$ 5
	Thickness, mm:
	Finger	0.05					min
	Palm	0.08					min
Remark	SAME

Table 3 Performance Comparison

ITEM	Proposed Device	Predicate Device (K163168)	Remark
Colorant	Clear, Non-Colored	White, Blue, Yellow	Analysis 1

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| Physical
Properties | | Tensile
Strength
Before | 15 MPa, min | 15 MPa, min | | |
|------------------------|--------------------|-------------------------------|------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|---------|
| | | Aging | Ultimate
Elongation | 380 % min | 380 % min | SAME |
| | | After | Tensile
Strength | 15 MPa, min | 15 MPa, min | |
| | | Aging | Ultimate
Elongation | 380 % min | 380 % min | |
| | | | Comply with ASTM D5250 | Comply with ASTM D5250 | SAME | |
| | Freedom from Holes | | | Be free from holes when tested in
accordance with ASTM D5151
AQL=1.5 | Be free from holes when tested
in accordance with ASTM
D5151 AQL=1.5 | SAME |
| | Powder Content | | | 0.5 mg | Meet the requirements of ASTM
5250 | SIMILAR |

Table 4 Safety Comparison

ITEM	Proposed Device	Predicate Device (K163168)	Remark
Material	Vinyl	Vinyl	SIMILAR
Biocompatibility	Irritation	Under the conditions of the study, not an irritant	Comply with ISO 10993-10	SIMILAR
	Sensitization	Under conditions of the study, not a sensitizer.
	Cytotoxicity	Under conditions of the study, did not show potential toxicity to L-929 cells.	/
Label and Labeling	Meet FDA's Requirements	Meet FDA's Requirements	SAME

Analysis 1:

The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility test, the test results shown difference do not effect the safety of proposed device.

8. Non-Clinical Test Conclusion

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

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Cytotoxicity

• ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves

• ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves.

• ASTM D5250-06 (Reapproved 2015), Standard Specification for Poly(vinyl chloride) Gloves for Medical Application.

• ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.

• Clinical Test Conclusion 9.

Clinical testing is not needed for this device.

• 10. 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 predicate device.