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.

AI/ML Overview

The provided text details the 510(k) summary for the "Vinyl Patient Examination Glove (Yellow)" (K173580) and compares it to a predicate device (K163168). The information specifically relates to the technical specifications and performance of the examination gloves, rather than an AI/ML device or a medical imaging system. Therefore, many of the requested categories in the prompt regarding AI/ML device evaluation are not applicable.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for the Vinyl Patient Examination Glove (Yellow) are primarily based on established industry standards and specific physical and biological properties. The reported device performance is presented in comparison to a predicate device and adherence to these standards.

ITEM	Acceptance Criteria (Proposed Device K173580)	Reported Device Performance (Proposed Device K173580)	Predicate Device (K163168) Performance
Product Code	LYZ	LYZ	LYZ
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	21 CFR 880.6250
Class	I	I	I
Intended Use	Disposable device for medical purposes, worn on examiner's hands to prevent contamination between patient and examiner.	Meets intended use.	Meets intended use.
Powdered or Powder free	Powder free	Powder free	Powder free
Design Feature	Ambidextrous	Ambidextrous	Ambidextrous
Labeling Information	Single-use indication, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile.	Meets labeling requirements.	Meets labeling requirements.
Length (min)	230 mm (S, M, L, XL)	S: 230mm, M: 230mm, L: 230mm, XL: 230mm	S: 230mm, M: 235mm, L: 245mm, XL: 245mm (XS: 230mm)
Width (tolerance)	+/- 5 mm	S: 85mm, M: 95mm, L: 105mm, XL: 115mm	S: 85mm, M: 95mm, L: 105mm, XL: 115mm (XS: 80mm)
Finger Thickness (min)	0.05 mm	0.05 mm	0.05 mm
Palm Thickness (min)	0.08 mm	0.08 mm	0.08 mm
Comply with ASTM D5250	Yes	Yes (Analysis 1 and 2 confirm compliance despite differences in specific values)	Yes
Colorant	Yellow	Yellow	White, Blue, Yellow
Tensile Strength Before Aging (min)	12 MPa	12 MPa	15 MPa
Ultimate Elongation Before Aging (min)	300 %	300 %	380 %
Tensile Strength After Aging (min)	12 MPa	12 MPa	15 MPa
Ultimate Elongation After Aging (min)	300 %	300 %	380 %
Freedom from Holes	Be free from holes when tested in accordance with ASTM D5151 Level=G-I, AQL=1.5	Meets this criterion.	Be free from holes when tested in accordance with ASTM D5151 AQL=1.5
Powder Content	Meets requirements of ASTM D5250	1.8 mg (Implied to meet requirement)	Meets requirements of ASTM 5250
Material	Vinyl	Vinyl	Vinyl
Biocompatibility (Irritation)	Not an irritant (Comply with ISO 10993-10)	Not an irritant	Not an irritant
Biocompatibility (Sensitization)	Not a sensitizer (Comply with ISO 10993-10)	Not a sensitizer	Not a sensitizer
Biocompatibility (Cytotoxicity)	Not show potential toxicity to L-929 cells (Comply with ISO 10993-5)	Not show potential toxicity to L-929 cells	Not show potential toxicity to L-929 cells
Label and Labeling	Meet FDA's Requirements of 21 CFR 801	Meets FDA's requirements.	Meets FDA's requirements.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify general "test set" sample sizes or data provenance in the context of clinical studies (as it states "No clinical study is included in this submission"). For non-clinical tests like physical properties and freedom from holes, the standards (e.g., ISO 2859-1 for sampling) outline the sampling procedures, but specific sample sizes used in this submission are not explicitly stated. The manufacturer is "NATURE MEDICAL PRODUCTS CO., LTD." in Hebei, China, which suggests the tests were likely conducted in China. These non-clinical tests would be considered prospective for the device being evaluated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a Vinyl Patient Examination Glove, not an AI/ML device requiring expert medical interpretation for ground truth. The "ground truth" for these types of devices is based on established laboratory testing and adherence to recognized performance standards (e.g., ASTM, ISO standards) for physical and biological properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable since this document relates to a physical medical device (examination gloves) and not a diagnostic system requiring human interpretation or adjudication for ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an examination glove, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is an examination glove.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on:

Industry Standards: Compliance with established physical and chemical property requirements outlined in standards such as ASTM D5250, ASTM D5151, ASTM D6124.
Biocompatibility Testing: Results from in vitro and in vivo tests (ISO 10993-5, ISO 10993-10) determining irritation, sensitization, and cytotoxicity.
Manufacturing Specifications: Adherence to the manufacturer's own design and material specifications.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of an AI/ML model for this type of physical medical device.

9. How the ground truth for the training set was established

This is not applicable as there is no training set for an AI/ML model.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
1. Sponsor Identification

NATURE MEDICAL PRODUCTS CO., LTD. No.7 WEST STREET, SIGEZHUANG TOWN, BENCHENG, HEBEI,CHINA

Contact Person: Chao kevin Position: General Manager Tel: +86- 315-4168700 Fax: +86- 315-4168700 Email: zhplylyp@outlook.com

1. Designated Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

Tel: +86-18910677558, Fax: +86-21-68093116 Email: Ray.Wang@believe-med.com

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1. 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.

1. 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.
1. 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 orPowered free	Powdered free	Powdered free	SAME
Design Feature	ambidextrous	ambidextrous	SAME
LabelingInformation	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
PhysicalProperties	TensileStrengthBeforeAging	12 MPa, min	15 MPa, min	Analysis 2

	UltimateElongation	300 % min	380 % min
	TensileStrengthAfterAging	12 MPa, min	15 MPa, min

	UltimateElongation	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 inaccordance with ASTM D5151Level=G-I, AQL=1.5	Be free from holes when testedin accordance with ASTMD5151AQL=1.5	SAME
Powder Content	1.8 mg	Meet the requirements of ASTM5250	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 asensitizer.
	Cytotoxicity	Under conditions of the study, didnot show potential toxicity to L-929cells.	N/A
Label and Labeling	Meet FDA's Requirements of 21CFR 801	Meet FDA's Requirements f 21 CFR801	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.
1. 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.

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.