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

Powder-free Vinyl Patient Examination Gloves, Yellow Color. A disposable device intended for medical purposes that is worn upon the examiner's hands or finger. Prevent contamination between patient and examiner. Cover the hand and wrist area. Covers have separate sheaths or openings for each finger and the thumb.

AI/ML Overview

This document is a 510(k) summary for a medical device: Powder-free Vinyl Patient Examination Gloves, Yellow Color. It focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "device" in this context is the glove itself, not an AI or software-based medical device.

As a result, most of the requested information regarding AI/ML device studies (such as sample sizes for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established) is not applicable to this type of medical device filing.

However, I can extract the acceptance criteria and reported performance for the physical characteristics of the gloves based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "Confirmed with ASTM D5250-06" or "Meet ASTM D5250-06" for physical properties and "Meet ASTM D6124-06" for residual powder. For biocompatibility, the criteria are "Not a sensitizer" and "Not an irritant." The reported device performance indicates that the proposed device meets these standards.

Acceptance Criteria / Performance Metric	Acceptance Criteria	Reported Device Performance
Physical Properties (per ASTM D5250-06):
Length on Large Size	Confirmed with ASTM D5250-06	Confirmed with ASTM D5250-06
Width of Palm on Large Size	Confirmed with ASTM D5250-06	Confirmed with ASTM D5250-06
Palm Thickness	Confirmed with ASTM D5250-06	Confirmed with ASTM D5250-06
Fingertip Thickness	Confirmed with ASTM D5250-06	Confirmed with ASTM D5250-06
Pinhole Results	Meet ASTM D5250-06	Meet ASTM-D-5250-06
Before Aging: Tensile Strength(Mpa) and Ultimate Elongations	Meet ASTM D5250-06	Meet ASTM D5250-06
After Aging: Tensile Strength(Mpa) and Ultimate Elongations	Meet ASTM D5250-06	Meet ASTM D5250-06
Other Non-Clinical Results:
Residual Powder	Meet ASTM D6124-06 (or <2 mg per glove)	<2 mg per glove and meet the requirement of ASTM D6124-06.
Dermal Sensitization	Not a sensitizer	Not a sensitizer
Primary Skin Irritation	Not an irritant	Not an irritant
Water Fill Test (for pinholes)	AQL 2.5, Inspection Level I	Conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements. (This appears to be an alternative or supplementary test to the ASTM D5250-06 pinhole test mentioned above, but both confirm the absence of pinholes to acceptable levels.)

2. Sample size used for the test set and the data provenance

The document mentions "Inspection Level S-2, AQL 2.5" for ASTM-D-5250-06 testing and "samplings of AQL 2.5, Inspection Level I" for the 1000 ml. Water Fill Test. These are sampling plans/Acceptable Quality Limits (AQLs) taken from standards for quality control inspections, which describe the proportion of defective items allowable in a batch and the sample size to be drawn based on batch size. However, the exact numerical sample size (e.g., "n=X gloves") is not explicitly stated.

The data provenance is implied to be from testing conducted by Zibo Ling Yun Medical Products Co. Ltd in China, as it is the submitter's identification. The tests were non-clinical/bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a physical medical device (examination gloves), not an AI/ML device that requires expert-established ground truth for algorithm performance. The "truth" is determined by standardized physical and chemical tests.

4. Adjudication method for the test set

Not Applicable. As above, this is not an AI/ML device requiring expert adjudication. The test results are objective measurements against established standards.

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

Not Applicable. This is a physical medical device and does not involve AI or human readers.

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

Not Applicable. This is a physical medical device and does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for the performance of these gloves is defined by adherence to established international consensus standards (ASTM D5250-06 for physical properties, ASTM D6124-06 for residual powder) and biocompatibility tests (dermal sensitization and primary skin irritation). These are objective, measurable criteria.

8. The sample size for the training set

Not Applicable. This is a physical medical device using established manufacturing and quality control processes, not an AI/ML device that requires a training set.

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

Not Applicable. As above, no training set for an AI/ML model is involved.

Summary

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

July 9, 2015

Zibo Ling Yun Medical Products Co., Ltd. C/O Mr. Ray Zhou Official Correspondent Basic Medical Industries, Inc. 12390 East End Ave Chino, CA 91710

Re: K143340

Trade/Device Name: Powder-free Vinyl Patient Examination Gloves, Yellow Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 2, 2015 Received: June 5, 2015

Dear Mr. Zhou:

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.

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Page 2 - Mr. Zhou

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division 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) K143340

Device Name

Powder-free Vinyl Patient Examination Gloves, Yellow Color

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 Attachment

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510 (K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.

1. Submitter's Identification:

Zibo Ling Yun Medical Products Co. Ltd NO.318 Yuming Road Zibo Industrial Park Zibo City, Shandong China

Date summary prepared: July 8, 2015

2. Name of the Device:

Zibo Ling Yun Medical Products Co. Ltd Powder-free Vinyl Patient Examination Gloves, Yellow Color

3. Common name/classification name of the Device:

Powder-free Vinyl Patient Examination Gloves, Yellow Color

4. Contact Person:

Ray Zhou, Tel: 909-548-4828 Email:rayzhou@basicmedical.com

ર. Predicate Device Information:

Shijiazhuang Hongxiang Plastic Products Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves (K992821)

6. Device Description:

Subject device: Powder-free Vinyl Patient Examination Gloves, Yellow Color

i. Principal operation of the glove A disposable device intended for medical purposes that is worn upon the examiner's hands or finger

ii. Mechanism of action for achieving the intended effect Prevent contamination between patient and examiner

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iii. Reference to the standards

Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5, meet ASTM-D-5250-06. The residual powder testing conforms with standards of ASTM D-6124-06.

iv. Biocompatibility results Not an irritant; Not a sensitizer

v. Bench testing N/A

7. Intended 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.

8. Comparison to Predicate Devices:

Zibo Ling Yun Medical Products Co, Ltd Powder-free Vinyl Patient Examination Gloves, Yellow Color are similar to the Shijiazhuang Hongxiang Plastic Products Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves (K992821)

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

	Proposed Device (K143340)	Predicate Device (K992821)
Device Description	Zibo Ling Yun Medical Products Co, LtdPowder-free Vinyl Patient Examination Gloves,Yellow Color	Shijiazhuang Hongxiang Plastic ProductsLtd.SyntheticPowder-FreeVinylPatient Examination Gloves
Indication for Use	Disposable device intended for medicalpurposes that is worn on the examiner's hand orfinger to prevent contamination between patientand examiner	Disposable device intended for medicalpurposes that is worn on the examiner'shand or finger to prevent contaminationbetween patient and examiner
Basic Design	Cover the hand and wrist area. Covers haveseparate sheaths or openings for each finger andthe thumb.	Cover the hand and wrist area. Covershave separate sheaths or openings foreach finger and the thumb.
Regulation #	21 CFR 880.6250	21 CFR 880.6250
Device Class	Class I	Class I
Product Code:	LYZ	LYZ
Labeling	Labels include: Product name; color; "singleuse Only" size, piece count, lot number,distributor name, and manufacturer address.	Substantially equivalent
Physical Properties:Length on LargeSize	Confirmed with ASTM D5250-06	Confirmed with ASTM D5250-06
Physical Properties:Width of Palm onLarge Size	Confirmed with ASTM D5250-06	Confirmed with ASTM D5250-06
Physical Properties:Palm Thickness	Confirmed with ASTM D5250-06	Confirmed with ASTM D5250-06
Physical Properties:Fingertip Thickness	Confirmed with ASTM D5250-06	Confirmed with ASTM D5250-06
Non-Clinical results:Residual Powder	<2 mg per glove and meet the requirement ofASTM D6124-06.	Meet ASTM D6124-06
Non-Clinical results:Pinhole Results	Meet ASTM-D-5250-06	Meet ASTM-D-5250-06
Non-Clinical results:DermalSensitization	Not a sensitizer	Not a sensitizer
Non-Clinical results:Primary SkinIrritation	Not an irritant	Not an irritant
Dimensions withTolerances: BeforeAging: TensileStrength(Mpa) andUltimateElongations	Meet ASTM D5250-06	Substantially equivalent
Dimensions withTolerances: AfterAging: TensileStrength(Mpa) andUltimateElongations	Meet ASTM D5250-06	Substantially equivalent
Summary ofcomparison	Zibo Ling Yun Medical Products Co, Ltd Powder-free Vinyl Patient Examination Gloves, Yellow Color (subject device) and Shijiazhuang Hongxiang Plastic Products Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves (predicate device) are substantially equivalent in all technological characteristics, has similar intended uses and technological characteristics and performed similar to the predicate

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

The standards used for Zibo Ling Yun Medical Products Co, Ltd glove production are 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 AQL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization testing was conducted with results showing no primary skin irritant or sensitization reactions.

No special labeling claims. Our gloves are "powder-free." They contain no more than 2 mg powder per glove.

10. Sterilization

Not sterilized

11. Patient Contact

Patient contact is limited for surface-contacting and has less than 24 hour duration.

12. Discussion of Clinical Tests Performed:

Not Applicable

13. Conclusions:

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe and as effective, and performs as well as the legally marketed 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.