Vinyl Patient Examination Glove (Yellow)

• K Number: K173561
• Device Name: Vinyl Patient Examination Glove (Yellow)
• Manufacturer: Yurun Glove Co., Ltd.
• Date Cleared: 2018-02-12 ( 87 days)
• Product Code: LYZ
• Regulation Number: 880.6250

Intended Use

The Vinyl Patient Examination Glove (Yellow) 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 yellow. 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 device is a simple disposable glove and the summary explicitly states "Mentions AI, DNN, or ML: Not Found".

Therapeutic

No
The device is a medical glove intended to prevent contamination between patient and examiner, not to treat a disease or condition.

Diagnostic

No
The device is a medical glove, intended to prevent contamination between patient and examiner, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical product (gloves) and the testing described relates to the physical properties and biological compatibility of the gloves, not software functionality.

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 test performed in vitro (outside the body).
• Device Description: The description focuses on the physical characteristics and standards related to the glove's material and integrity, not on any reagents, instruments, or procedures used for diagnostic purposes.
• Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro testing.
• Performance Studies: The performance studies listed are related to the physical and biological safety of the glove (irritation, cytotoxicity, holes, powder), not to the accuracy or reliability of a diagnostic test.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is a physical barrier used during medical examinations.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Vinyl Patient Examination Glove (Yellow) 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 yellow. 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

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)

Non clinical tests were conducted to verify that the proposed device met all 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 D 5151-06 (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.)

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.

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 two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue.

February 12, 2018

Yurun Glove Co., Ltd. % Ray Wang Official Correspondent Beijing Believe-Med Technology Service Co., Ltd. 5-402, Building #27, No. 56, LiangXiang East Rd., FangShan District Beijing, 102401 Cn

Re: K173561

Trade/Device Name: Vinyl Patient Examination Glove (Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: November 15, 2017 Received: November 17, 2017

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,

Michael J. Ryan -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)

K173561

Device Name Vinyl Patient Examination Glove (Yellow)

Indications for Use (Describe)

The Vinyl Patient Examination Glove (Yellow) 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 of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K173561

• 1. Date of Preparation:2018/01/26
• 2. Sponsor Identification

YURUN GLOVE CO., LTD. No.10 ZHAOCAI STREET, LUANNAN COUNTY, SHITANGSHAN CITY, HEBEI,CHINA

Contact Person: Chao kevin Position: General 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 Patient Examination Glove (Yellow) 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: I Product Code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

Indication for use Statement:

The Vinyl Patient Examination Glove (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

• 5. Device Description
     The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is yellow. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.
• 6. Identification of Predicate Device(s)
     Predicate Device K163168 Vinyl Examination Gloves (White, Blue or Yellow) Hebei Hongtai Plastic Products Company Limited

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ITEM	Proposed Device (K173561)	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
(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
Powered free	Powdered free	Powdered free	SAME
Design Feature	ambidextrous	ambidextrous	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

Technological Comparison Table 7.

Table 1 General Comparison

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		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	±5
	Thickness, mm:
	Finger	0.05					min
	Palm	0.08					min
		Size
	Designation	S	M	L	XL	Tolerance
	Length, mm	230	230	230	230	min
Proposed Device (K173561)	Width, mm	85	95	105	115	±5
	Thickness, mm:
	Finger	0.05					min
	Palm	0.08					min
Remark		Analysis 1

Table 2 Device Dimensions Comparison

Analysis 1:

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

	Table 3 Performance Comparison

ITEM	Proposed Device (K173561)	Predicate Device (K163168)	Remark
Colorant	Yellow	White, Blue, Yellow	SAME
Physical
Properties	Before
Aging
Tensile
Strength	12 MPa, min	15 MPa, min	Analysis 2
	Before
Aging
Ultimate
Elongation	300 % min	380 % min
	After
Aging
Tensile
Strength	12 MPa, min	15 MPa, min
	After
Aging
Ultimate
Elongation	300 % min	380 % min
Freedom from Holes	Be free from holes when tested in
accordance with ASTM D5151
Level=G-I, AQL=1.5	Be free from holes when tested
in accordance with ASTM
D5151
AQL=1.5	SAME
Powder Content	1.7 mg	Meet the requirements of ASTM
5250	SAME

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ITEM	Proposed Device (K173561)	Predicate Device (K163168)	Remark
Material	Vinyl	Vinyl	SAME
Biocompatibility			SAME
	Irritation
Under the conditions of the study, not an irritant	Comply with ISO 10993-10
	Sensitization
Under conditions of the study, not a sensitizer.	N/A
Cytotoxicity
Under conditions of the study, did not show potential toxicity to L-929 cells.
Label and Labeling	Meet FDA's Requirements of 21
CFR 801	Meet FDA's Requirements of 21
CFR 801	SAME

		Table 4 Safety Comparison

Analysis 2:

The proposed device has different Ultimate Elongation after aging specification to the predicate device, but all proposed device meets the specification requirements of ASTM D 5250.

8. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all 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 D 5151-06 (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.

• 9. Clinical Test Conclusion

No clinical study is included in this submission.

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10. Comparison 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.