The Powder Free Yellow Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Description

The proposed device, Powder Free Yellow Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. The proposed is Powder Free Yellow Vinyl Patient Examination Gloves, and includes variations of different size.

AI/ML Overview

The provided text describes the 510(k) summary for "Powder Free Yellow Vinyl Patient Examination Gloves." This is a premarket notification for a Class I medical device (patient examination glove), which is regulated under 21 CFR 880.6250. The submission aims to demonstrate substantial equivalence to a predicate device (K091431).

Given that this is a 510(k) submission for a low-risk device like examination gloves, the "acceptance criteria" primarily relate to compliance with recognized standards and demonstrating equivalence to a predicate device rather than complex clinical endpoints or AI model performance. The "study" here refers to bench tests and biocompatibility assessments.

Here's a breakdown based on your request:

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

The acceptance criteria are derived from recognized standards (ASTM, ISO) and comparison to the predicate device. The reported performance aligns with these standards.

Acceptance Criteria (from Standards / Predicate)	Reported Device Performance (Proposed Device)	Remark
Material
Vinyl	Vinyl	SE
Dimensions (all sizes)
Length: ≥ 240 mm	240 mm (min)	SE
Width: ±5 mm (e.g., S: 85mm)	S: 85 mm, M: 95 mm, L: 105 mm, XL: 115 mm (±5 mm)	SE
Thickness: Finger: ≥ 0.10 mm	0.10 mm (min)	SE
Thickness: Palm: ≥ 0.08 mm	0.08 mm (min)	SE
Thickness: Cuff: ≥ 0.06 mm	0.06 mm (min)	SE
Physical Properties (Before Aging)
Tensile Strength: ≥ 13 MPa	13 MPa, min	SE
Ultimate Elongation: ≥ 400%	400 % min	SE
Physical Properties (After Aging)
Tensile Strength: ≥ 13 MPa	13 MPa, min	SE
Ultimate Elongation: ≥ 400%	400 % min	SE
Comply with ASTM D5250	Comply with ASTM D5250	SE
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	SE
Powder Content
Meet ASTM D5250 requirements (for powder-free)	0.61 mg per glove	SE
Biocompatibility
Irritation: Not an irritant (Comply with ISO 10993-10)	Under the conditions of the study, not an irritant	SE
Sensitization: Not a sensitizer (Comply with ISO 10993-10)	Under conditions of the study, not a sensitizer	SE
Label and Labeling
Meet FDA's Requirements	Meet FDA's Requirements	SE

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

The document explicitly mentions the use of 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." This standard details how sample sizes are determined for inspection based on the lot size and acceptable quality levels for attributes like holes, dimensions, and physical properties.

Sample Size: While the exact number of gloves or batches tested is not explicitly stated in this summary, it refers to ISO 2859-1 for sampling procedures, implying that samples were drawn from production lots according to this standard. For biocompatibility, standard practice involves a sufficient number of samples to represent the device and achieve statistically significant results (e.g., typically 3 device samples for in vitro tests, and appropriate animal numbers for in vivo tests as per ISO 10993-10).
Data Provenance: The tests were conducted by Zibo Huaqi Trading Company, Limited, which is based in China. The nature of these tests (bench tests, biocompatibility) implies they were prospective in the sense that they were specifically designed and executed for this 510(k) submission on samples of the manufactured device.

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 section is not applicable to this type of device. "Ground truth" and "experts" in the context of clinical interpretation (like radiologists) are relevant for diagnostic imaging or AI devices. For patient examination gloves, the "ground truth" is established by direct physical measurements, chemical analysis, and standardized biological assessments conducted by trained lab personnel following the protocols outlined in the referenced ASTM and ISO standards. There are no clinical interpretation experts involved in establishing the "ground truth" for the physical and biological characteristics of a glove.

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

This section is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple human readers assess cases and a consensus or tie-breaker mechanism is used to establish ground truth, particularly in the context of diagnostic performance or AI evaluation. For bench testing of gloves, results are typically objective measurements or observations (e.g., pass/fail for holes, numerical values for tensile strength) that do not require clinical adjudication.

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 section is not applicable. This device is a disposable patient examination glove; it does not involve any AI, human readers, or diagnostic interpretation. Therefore, an MRMC comparative effectiveness study is entirely irrelevant to this submission.

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

This section is not applicable. The device is a physical glove, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

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

The "ground truth" for the performance of these gloves is established through adherence to recognized international and national standards (ASTM D5250, ASTM D5151, ASTM D6124, ISO 2859-1, ISO 10993-10). The "truth" is whether the glove samples meet the specified physical, dimensional, and biological requirements outlined in these standards. This involves:

Direct Physical Measurement: For dimensions (length, width, thickness).
Controlled Testing Procedures: For tensile strength, elongation, hole detection, powder content.
Standardized Biocompatibility Tests: According to ISO 10993-10 for irritation and sensitization, which involves animal or in vitro tests as specified by the standard.

There is no "expert consensus" in the clinical sense, pathology, or outcomes data used to establish glove ground truth.

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI. The manufacturer's production processes and quality control systems would be refined over time (akin to "training" in a broad sense), but there is no specific quantifiable training set size as for an algorithm.

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

This section is not applicable for the same reason as point 8. There is no training set for a physical device. The manufacturing process is validated against specifications to ensure consistent quality.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19,2014

Zibo Huaqi Trading Company, Limited C/O Mr. Ray Wang Official Correspondent Beijing Believe Tech. Service Company, Limited 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Chaoyang District, Beijing, 100024 CHINA

Re: K142508

Trade/Device Name: Powder Free Yellow Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LYZ Dated: November 4, 2014 Received: November 7, 2014

Dear Mr. 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

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Page 2 - Mr. Ray Wang

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, mA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142508

Device Name

Powder Free Yellow Vinyl Patient Examination Gloves

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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Exhibit #7 510(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: _

1. Date of Preparation: Sept. 8, 2014
1. Sponsor

ZIBO HUAQI TRADING CO., LTD YIFAN ROAD,ZHANGDIAN DISTRICT,ZIBO 255000,SHANDONG,P.R.CHINA

Contact Person: Ms. Jing Li Tel: +86- 0533-3819144 Fax: +86-0533-3818127 Email: hclijing85@126.com

Submission Correspondent 3. Mr. Ray Wang Beijing Believe Tech. Service Co., Ltd. Tel: +86-21-50313932 Fax: +86-21-68093116 Email: Ray.Wang@believe-med.com
1. Proposed Device Identification

Trade Name: Powder Free Yellow Vinyl Patient Examination Gloves Device Name: Vinyl Patient Examination Gloves (Powder Free) Common Name: Patient Examination Gloves

Classification: I Product Code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

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Intended Use Statement:

1. Predicate Device Identification
  510(k) Number: K091431 Product Name: Patient Vinyl Examination Gloves, Yellow, Powder free Manufacturer: Zibo Yusheng Product Co., Ltd.

6. Device Description

The proposed is Powder Free Yellow Vinyl Patient Examination Gloves, and includes variations of different size.

1. 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 D5250-06, Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. ASTM D 5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.

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

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.

ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

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8. Substantially Equivalent Comparison Conclusion

ITEM	Proposed DevicePowder Free Yellow VinylPatient Examination Gloves	Predicate Device (K091431)Patient Vinyl Examination Gloves	Remark
Product Code	LYZ	LYZ	SE
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	SE
Class	I	I	SE
Intended Use	The Powder Free Yellow VinylPatient Examination Gloves is a disposabledevice intended for medical purposes that isworn on the examiner's hands or finger toprevent contamination between patient andexaminer.	A patient examination glove is a disposabledevice intended for medical purposes that isworn on the examiner's hands or finger toprevent contamination between patient andexaminer.	SE
Powdered orPowered free	Powdered free	Powdered free	SE

Table 1 General Comparison

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Proposed DevicePowder Free Yellow VinylPatient Examination Gloves	Designation	S	M	L	XL	Tolerance
	Length, mm	240	240	240	240	min
	Width, mm	85	95	105	115	±5
	Thickness, mm:
	Finger	0.10				min
	Palm	0.08				min
	Cuff	0.06				min
Predicate Device (K091431)Patient Vinyl ExaminationGloves	Designation	S	M	L	XL	Tolerance
	Length, mm	240	240	240	240	min
	Width, mm	85	95	105	115	±5
	Thickness, mm:
	Finger	0.10				min
	Palm	0.08				min
	Cuff	0.06				min
Remark	SE

Table 2 Device Dimensions Comparison

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			Proposed Device	Predicate Device (K091431)
ITEM			Powder Free Yellow VinylPatient Examination Gloves	Patient Vinyl ExaminationGloves	Remark
Colorant			Yellow	Yellow	SE
PhysicalProperties	BeforeAging	TensileStrength	13 MPa, min	13 MPa, min	SE
		UltimateElongation	400 % min	400 % min	SE
	AfterAging	TensileStrength	13 MPa, min	13 MPa, min	SE
		UltimateElongation	400 % min	400 % min	SE
			Comply with ASTM D5250	Comply with ASTM D5250	SE
Freedom from Holes			Be free from holes when tested inaccordance with ASTM D5151	Be free from holes when testedin accordance with ASTM D5151	SE
Powder Content			0.61 mg per glove	Meet the requirements of ASTM5250	SE

Table 3 Performance Comparison

Table 4 Safety Comparison

ITEM	Proposed DevicePowder Free Yellow VinylPatient Examination Gloves	Predicate Device (K091431)Patient Vinyl Examination Gloves	Remark
Material	Vinyl	Vinyl	SE
Biocompatibility	IrritationUnder the conditions of the study,not an irritant	Comply with ISO 10993-10	SE
	SensitizationUnder conditions of the study, not asensitizer
Label and Labeling	Meet FDA's Requirements	Meet FDA's Requirements	SE

The proposed device, Powder Free Yellow Vinyl Patient Examination Gloves, is determined to be Substantially Equivalent (SE) to the predicate device in respect of safety and effectiveness.

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.