Vinyl Patient Examination Glove (Yellow)

• K Number: K173580
• Device Name: Vinyl Patient Examination Glove (Yellow)
• Manufacturer: Nature Medical Products Co.,Ltd.
• Date Cleared: 2018-02-15 ( 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 contains no mention of AI or ML.

Therapeutic

No.
The device's intended use is to prevent contamination, not to treat or diagnose a disease or condition.

Diagnostic

No
The device is a patient examination glove used to prevent contamination, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device is a physical product (gloves) and the description focuses entirely on material properties and physical testing, with no mention of software.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is clearly stated as being 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 material, color, and adherence to standards related to glove properties (like powder content, integrity, and physical characteristics). There is no mention of analyzing samples or providing diagnostic information.
• Lack of Diagnostic Elements: There are no mentions of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing any kind of diagnostic result.
• Performance Studies: The performance studies described are non-clinical tests verifying compliance with standards related to the physical and biological properties of the glove, not diagnostic accuracy.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not perform any of those functions.

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

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)

K163168

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 15, 2018

Nature Medical Products 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: K173580

Trade/Device Name: Vinyl Patient Examination Glove (Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: November 15, 2017 Received: November 20, 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)

K173580

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 is being submitted in accordance with Title 21, CFR Section 807.92.

The assigned 510(k) Number: K173580

• 1. Date of Preparation:2018/01/27
• 2. Sponsor Identification

NATURE MEDICAL PRODUCTS CO., LTD. No.7 WEST STREET, SIGEZHUANG TOWN, BENCHENG, 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 and Yellow) Hebei Hongtai Plastic Products Company Limited

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ITEM	Proposed Device (K173580)	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

7. Technological Comparison

Table 1 General Comparison

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	Size
Designation	XS	S	M	L	XL	Tolerance
Predicate Device (K163168)	Length, mm	230	230	235	245	245	min
	Width, mm	80	85	95	105	115	$\pm$ 5
	Thickness, mm:
	Finger	0.05					min
	Palm	0.08					min
Size
Designation	S	M	L	XL		Tolerance
Proposed Device (K173580)	Length, mm	230	230	230	230		min
	Width, mm	85	95	105	115		$\pm$ 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 (K173580)	Predicate Device (K163168)	Remark
Colorant	Yellow	White, Blue, Yellow	SAME
Physical
Properties	Tensile
Strength
Before
Aging	12 MPa, min	15 MPa, min	Analysis 2
	Ultimate
Elongation	300 % min	380 % min
	Tensile
Strength
After
Aging	12 MPa, min	15 MPa, min
	Ultimate
Elongation	300 % min	380 % min
Comply with ASTM D5250	Comply with ASTM D5250	Comply with ASTM D5250	SAME
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	1.8 mg	Meet the requirements of ASTM
5250	SAME

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ITEM	Proposed Device (K173580)	Predicate Device (K163168)	Remark
Material	Vinyl	Vinyl	SAME
Biocompatibility	Irritation	Under the conditions of the study,
not an irritant	Comply with ISO 10993-10	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.	N/A
Label and Labeling	Meet FDA's Requirements of 21
CFR 801	Meet FDA's Requirements f 21 CFR
801	SAME

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.