A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Description

A Powder-free Clear Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250). Our Powder-free Clear Vinyl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria (Predicate Devices/Standards)	Reported Device Performance (K171460)
Residual Powder	Less than 2 mg per glove (ASTM D6124-06)	Testing result indicates the weight of all types of residual powder on finished powder-free gloves as < 2 mg per glove and there is no defect glove found according to ASTM D6124-06.
Pinhole Results	AQL 2.5 (ASTM D5151-06)	According to ASTM D5151-06, testing result indicates pinhole were found less than two pieces gloves out of 125 pieces gloves. AQL 2.5 is met.
Before Aging:	Similar to predicate devices (K022091, K100699)	Average Tensile Strength (Mpa): 16.96; Average Ultimate Elongations: 519%
Tensile Strength (Mpa)
Ultimate Elongations
After Aging:	Similar to predicate devices (K022091, K100699)	Average Tensile Strength (Mpa): 14.92; Average Ultimate Elongations: 480%
Tensile Strength (Mpa)
Ultimate Elongations
Biocompatibility:	Not an irritant (Primary Skin Irritation)	Under the conditions of the study, the subject device is not an irritant.
Primary Skin Irritation
Dermal Sensitization	Not a sensitizer (Dermal Sensitization)	Under the conditions of the study, the subject device is not a sensitizer.
Physical and Dimensions	Meets ASTM-D-5250-06 requirements	All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.
Length on Large Size	Similar to predicate devices	Average over 231.62mm
Width of Palm on Large Size	Similar to predicate devices	Average 95mm
Palm Thickness	Similar to predicate devices	Average 0.095 mm
Fingertip Thickness	Similar to predicate devices	Average 0.09 mm
Water Fill Test	Meets FDA 1000 ml. Water Fill Test requirements (AQL 2.5, Inspection Level I)	The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, meeting these requirements.

Sample size used for the test set and the data provenance:
- Test Set Sample Sizes:
  - Pinhole Results: 125 gloves.
  - Residual Powder: Not explicitly stated but testing performed "per standards of ASTM D-6124-06" which would imply a specific sampling plan.
  - Tensile Strength & Elongation (Before & After Aging): Not explicitly stated, but implies a sample of gloves tested according to ASTM-D-5250-06.
  - Biocompatibility (Primary Skin Irritation & Dermal Sensitization): A study was conducted, but the number of subjects or samples is not specified.
  - Physical and Dimensions Testing: Inspection Level S-2, AQL 2.5.
  - FDA 1000 ml. Water Fill Test: Samplings of AQL 2.5, Inspection Level I.
- Data Provenance: The document implies the testing was conducted by or on behalf of Shandong Zhiwei Medical Products Co., Ltd., based in China, for regulatory submission to the FDA. The nature (retrospective/prospective) of these specific tests is not stated, but they are typically prospective functional and safety tests performed on representative samples of the manufactured device.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- This submission is for a patient examination glove, a relatively simple medical device. The "ground truth" for the performance characteristics (e.g., tensile strength, pinholes, residual powder, biocompatibility) is established through standardized laboratory testing protocols (e.g., ASTM standards) rather than expert consensus on medical images or clinical outcomes.
- Therefore, the concept of "experts" to establish a ground truth in the way it applies to diagnostic AI devices (e.g., radiologists interpreting images) is not directly applicable here. The "experts" would be the qualified laboratory personnel conducting the tests according to the specified ASTM and FDA protocols, ensuring adherence to the methodology. Their specific number and qualifications (e.g., years of experience in materials testing, chemistry, or toxicology) are not detailed in this summary.
Adjudication method for the test set:
- Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation (e.g., radiologists, pathologists) where disagreements need to be resolved.
- For the laboratory-based performance and safety testing of this medical device, adjudication in this sense is not directly applicable. The "adjudication" is inherent in the adherence to standardized testing methods (e.g., ASTM standards), where objective measurements are taken, and results are compared against predefined acceptance criteria. Any deviations or borderline results would typically lead to re-testing or investigation according to quality control procedures.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) are assisted by AI. This device is a physical patient examination glove and does not involve human interpretation or AI assistance in the same context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical product, not an algorithm or software. The performance evaluations are based on the intrinsic physical, chemical, and biological properties of the glove itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on objective measurements and standardized test results against established industry and regulatory standards.
  - Physical Properties: Measured values for tensile strength, elongation, length, width, and thickness are the ground truth, compared against "similar" performance of predicate devices and ASTM D5250-06 requirements.
  - Pinhole Detection: The quantifiable count of pinholes in a sample is the ground truth, compared against an AQL of 2.5 (ASTM D5151-06) and the FDA 1000 ml. Water Fill Test.
  - Residual Powder: The measured weight of residual powder is the ground truth, compared against the <2 mg/glove criterion of ASTM D6124-06.
  - Biocompatibility: The observed biological response in irritation and sensitization tests (e.g., "not an irritant," "not a sensitizer") serves as the ground truth, assessed under specific study conditions.
The sample size for the training set:
- This document describes the premarket notification (510(k)) for a physical medical device (patient examination gloves). It does not involve machine learning or AI, and therefore, there is no "training set" in the context of algorithm development. The gloves are manufactured, and samples from production lots are tested to ensure quality and demonstrate substantial equivalence.
How the ground truth for the training set was established:
- As there is no AI/ML involved and thus no "training set," this question is not applicable. The "ground truth" for the device's performance is established through adherence to the testing methodologies themselves as described in item 7.

Summary

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

September 24, 2017

Shandong Zhiwei Medical Products, Co. Ltd. % Melo Zhang Official Correspondent Intco Medical Industries, Inc. 805 Barrington Ave. Ontario, California 91764

Re: K171460

Trade/Device Name: Powder-free Clear Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: July 28, 2017 Received: May 18, 2017

Dear Melo Zhang:

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

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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 devicerelated 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 (DICE) 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) 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, Tara A. Ryan -S 2017.09.24 19:33:34 -04'00'

for

Tina Kiang, PhD 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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Indications for Use

510(k) Number (if known) K171460

Device Name

Powder-free Clear Vinyl Patient Examination Gloves

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.

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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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510 (K) SUMMARY

1. Submitter's Identification:

Shandong Zhiwei Medical Products Co., Ltd. No. 4519 Oingzhou Road Shao De Industrial Park China Contact Person: Melo Zhang Official Correspondent

Date summary prepared: September 13, 2017

2. Name of the Device:

Shandong Zhiwei Medical Products Co., Ltd. Powder-free Clear Vinyl Patient Examination Gloves Classification Name: Patient Examination Glove Product Code: LYZ Product Class: Class I Regulation #: 21 CFR 880.6250 Classification Panel: General Hospital

3. Trade Name

Shandong Zhiwei Medical Products Co., Ltd. Powder-free Clear Vinyl Patient Examination Gloves

4. Predicate Device Information:

Shijiazhuang Star Plastic Co., Ltd. Powder Free Vinyl Examination Gloves - (K100699)

Tangshan Zhonghong Pulin Food Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves - (K022091)

5. Device Description:

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testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.

6. Indication for Use:

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

7. Comparison to Predicate Devices:

Table 7-2. Side-by-Side Comparison of Intended Use, Design, Material, Physical, Biocompatibility, and Performance Testing

	Proposed Device(K171460)	Predicate Device(K022091)	Predicate Device(K100699)
Description	Shandong Zhiwei MedicalProducts Co., Ltd. Powder-freeClear Vinyl Patient ExaminationGloves	TangshanZhonghong PulinFood Products Co.,Ltd Class I vinylpatient examinationgloves, powder-free	Shijiazhuang StarPlastic Co., LtdPowder Free VinylPatientExaminationGloves
	Indication forUse	Disposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner	similar	similar
		Basic Design	A garment covering the hand andwrist area. Clovers have separatesheaths or openings for each fingerand the thumb.	similar	similar
			Materials Used	Poly Vinyl Chloride	Poly VinylChloride	Poly VinylChloride
			Single Use	Yes	Yes	Yes
		Sterile	Not sterile	Not sterile	Not sterile
Length on LargeSize	Average over 231.62mm	Similar	Similar
Width of Palmon Large Size	Average 95mm	Similar	Similar
Palm Thickness	Average 0.095 mm	Similar	Similar
FingertipThickness	Average 0.09 mm	Similar	Similar
Residual Powder	According to ASTM D6124-06Standard Test Method for Residual	Similar	Similar

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	Powder on Medical gloves for thedetermination of residual powdercontent. Testing result indicatesthe weight of all types of residualor powder on finished powder-freegloves as < 2 mg per glove andthere is no defect glove foundaccording to ASTM D6124-06.
Pinhole Results	According to ASTM D5151-06,Testing result indicates pinholewere found less than two piecesgloves out of 125 pieces gloves.AQL 2.5 is met.	Similar	Similar
Before Aging:TensileStrength(Mpa)and UltimateElongations	Average Tensile Strength (Mpa):16.96Average Ultimate Elongations:519%	Similar	Similar
After Aging:TensileStrength(Mpa)and UltimateElongations	Average Tensile Strength (Mpa):14.92Average Ultimate Elongations:480%	Similar	Similar
BiocompatibilityResult: PrimarySkin Irritation	Under the conditions of the study,the subject device is not an irritant	Similar	Similar
DermalSensitization	Under the conditions of the study,the subject device is not ansensitizer	Similar	Similar

Discussion of Non-Clinical tests performed for Determination of Substantial 8. Equivalence are as follows:

The standards used for Shandong Zhiwei Medical Products Co., Ltd. glove production is based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.

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There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).

9. Conclusion:

Shandong Zhiwei Medical Products Co., Ltd. Powder-free Clear Vinyl Patient Examination Gloves is as safe, as effective and is demonstrated to be substantially equivalent to the 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.