A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Powder Free Polyethylene Examination Gloves are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of translucent (clear) Low Density Polyethylene materials and are powder free. The gloves are loose fitting. The physical and performance characteristics of the devices meet all requirements of ASTM standard D-5250-06 (2011) Standard Specification for Poly(vinyl Chloride) Gloves for Medical Application.

AI/ML Overview

The provided text is a 510(k) summary for "Powder Free Polyethylene Examination Gloves," which is a Class I medical device. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device requiring extensive clinical trials. Therefore, the acceptance criteria and study information typically found for AI/ML-driven medical devices or complex diagnostic devices are not present.

Based on the document, here's an analysis of the provided information, noting where specific details (like those related to AI/ML studies) are not applicable:

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

The acceptance criteria for this device are based on meeting established ASTM standards for patient examination gloves and demonstrating biocompatibility. The "reported device performance" section directly states that the subject device "Meets" these standards, indicating compliance. The table combines acceptance criteria with reported performance, as the predicate device also "Meets" these, establishing substantial equivalence.

Characteristics	Standard	Predicate Device Performance	Subject Device Performance	Comparison
Product Code	/	LZA	LZA	Substantial equivalence
Intended Use	/	Meets	Meets	Substantial equivalence
Labeling	/	Meets	Meets	Substantial equivalence
Device Materials	/	Polyethylene	Polyethylene	Substantial equivalence
Color	/	Translucent (Clear)	Translucent (Clear)	Substantial equivalence
Tensile strength: before and after aging	ASTM D5250-06 (2011)	Meets	Meets	Substantial equivalence
Ultimate elongation: before and after aging	ASTM D5250-06 (2011)	Meets	Meets	Substantial equivalence
Freedom from pinholes	ASTM D5250-06 (2011)	Meets	Meets	Substantial equivalence
Dimensions: Overall length, Width, Palm and Finger thickness	ASTM D5250-06 (2011)	Meets	Meets	Substantial equivalence
Residual powder	ASTM D5250-06 (2011), ASTM D6124-06	Meets	Meets	Substantial equivalence
Primary skin irritation test	ISO 10993 Part 10	Passes	Passes	Substantial equivalence
Dermal sensitization assay	ISO 10993 Part 10	Passes	Passes	Substantial equivalence

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 does not specify a "test set" sample size in the context of clinical trials or AI/ML model validation, because this submission is for a Class I general purpose glove based on performance standards. The testing performed (such as dimensions, physical properties, freedom from holes, residual powder, and biocompatibility) would have involved specific sample sizes as determined by the relevant ASTM and ISO standards, but these details are not provided in the summary beyond stating "Meets" or "Passes."

Data provenance would typically refer to the source of patient data. Since this is non-clinical testing of a physical device, there is no patient data involved. The tests were performed on the manufactured gloves.

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)

Not applicable. "Ground truth" in the context of expert consensus is typically relevant for diagnostic devices interpreting medical images or other complex data. For examination gloves, the "ground truth" is defined by the objective physical and chemical testing standards (ASTM, ISO). The results are determined by laboratory measurements, not expert interpretation.

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

Not applicable. Adjudication methods are typically used to resolve discrepancies among experts in interpreting complex data (e.g., medical images). As the ground truth is established by objective physical and chemical tests, there is no need for expert 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

Not applicable. This device is a physical examination glove and does not involve AI, human readers, or the interpretation of medical cases. MRMC studies and effect sizes related to AI assistance are irrelevant in this context.

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

Not applicable. This device is a physical product and does not involve algorithms or AI performance.

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

The "ground truth" for this device's performance is established by objective engineering and biocompatibility standards. Specifically:

ASTM D 5250-06 (2011) for physical properties (dimensions, tensile strength, elongation, freedom from holes) and residual powder.
ASTM D6124-06 (Reapproved 2011) for residual powder.
ISO 10993 Part 10 for primary skin irritation and dermal sensitization (biocompatibility).
FDA 21 CFR 800.20 for freedom from holes.

These standards provide measurable criteria that determine whether the device meets its intended specifications.

8. The sample size for the training set

Not applicable. There is no AI/ML model, and therefore no training set. The "training" for this product involves adhering to manufacturing processes that enable the gloves to meet the predefined standards.

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

Not applicable. As there is no AI/ML training set, there is no ground truth establishment for it.

Summary

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Donggao Industrial Zone, Zanhuang, Hebei, China 050000

Product: Powder Free Polyethylene Examination Gloves

JUN - 2 2014

510(K) SUMMARY

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

The assigned 510(K) number is: K133478

l. Owner's Identification:

Ms. Huizhen Qu Shijiazhuang Hongzan Plastic Technology Co., Ltd Donggao Industrial Zone, Zanhuang, Hebei, China 050000

Tel: 86-311-83601854 Fax: 86-311- 83616934

Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611 Fax: 909-590-1511 Date Summary Prepared: April 19, 2014

2. Name of the Device:

Trade Name: Powder Free Polyethylene Examination Gloves Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LZA Device Class: Class I

3. Predicate Device Information:

AmerCare Inc. C2 Powder Free Polyethylene Examination Glove (K113639)

4. Device Description:

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Donggao Industrial Zone, Zanhuang, Hebei, China 050000

Product: Powder Free Polyethylene Examination Gloves

5. Intended Use of the Device:

A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

6. Technological Characteristics and Substantial Equivalence:

Shijiazhuang Hongzan Plastic Technology Co., Ltd.'s Powder Free Polyethylene Examination Gloves is substantially equivalent in safety and effectiveness to the AmerCare Inc.'s C2 Powder Free Polyethylene Examination Glove (K113639). The subject device and predicate device use a similar plastic flexible barrier film to achieve a device for the intended use.

And the properties between the subject device and the predicate device are compared in the following table: Device Performance Result of Characteristics Standard Dradicate Device Subject Device omnarison

Product Code		Predicate Device	Subject Device	comparison
Product Code	/	LZA	LZA	Substantialequivalence
Intended Use	/	Predicate device isa disposable deviceintended formedical purposethat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner.	Subject device isdisposable non-sterile deviceintended formedical purposethat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner.	Substantialequivalence
Labeling	/	There are nospecial labelingclaims and do notclaim gloves ashypoallergenic onlabels.	There are nospecial labelingclaims and do notclaim gloves ashypoallergenic onlabels.	Substantialequivalence
DeviceMaterials	/	Polyethylene	Polyethylene	Substantialequivalence
Color	/	Translucent (Clear)	Translucent (Clear)	Substantialequivalence

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Donggao Industrial Zone, Zanhuang, Hebei, China 050000

	Standard	Device Performance		Result of
Characteristics		Predicate Device	Subject Device	comparison
Device tolerances and specifications & Performance Data:
Tensilestrength:beforeandafteraging	ASTMD5250-06 (2011)	Meets	Meets	Substantialequivalence
Ultimateelongation: beforeand after aging	ASTMD5250-06 (2011)	Meets	Meets	Substantialequivalence
Freedomfrompinholes	ASTMD5250-06 (2011)	Meets	Meets	Substantialequivalence
Dimensions:Overalllength,Width, Palm andFinger thickness	ASTMD5250-06 (2011)	Meets	Meets	Substantialequivalence
Residual powder	ASTMD5250-06 (2011)ASTM D6124-06	Meets	Meets	Substantialequivalence
Biocompatibility
Primary skin irritation test			PassesNot a primary skinirritation	PassesNot a primary skinirritation	Substantialequivalence
Dermal sensitization assay			PassesNot a dermalsensitization	PassesNot a dermalsensitization	Substantialequivalence

Product: Powder Free Polyethylene Examination Gloves

Shijiazhuang Hongzan Plastic Technology Co., Ltd's Powder Free Polyethylene Examination Gloves shares the same technology characteristics compared to the predicate device. The subject device performs according to the glove performance standards ASTM D5250-06(2011), biocompatibility requirement and FDA requirements and the labeling claims for the product. It performs as well as the legally marketed predicate device.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:

Characteristics	ApplicableRecognized Standards	Performance Results
Dimensions	ASTM D 5250-06 (2011)	Meets
Physical Properties	ASTM D 5250-06 (2011)	Meets
Freedom from holes	ASTM D 5250-06 (2011)FDA 21CFR800.20	Meets

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Donggao Industrial Zone, Zanhuang, Hebei, China 050000

Characteristics	Applicable FDA-Recognized Standards	Performance Results
Residual Powder Test	ASTM D 5250-06 (2011)ASTM D6124-06(Reapproved 2011)	Meets
Primary Skin Irritationand Skin Sensitization	ISO 10993 Part 10	Meets

Product: Powder Free Polyethylene Examination Gloves

8. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic Claim. There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the nonclinical testing.

9. Labeling:

There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.

10. Conclusions:

Shijiazhuang Hongzan Plastic Technology Co., Ltd.'s Powder Free Polyethylene Examination Gloves conform fully to ASTM D-5250-06(2011) standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data discussed above. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited. Drawn from the complete list of non-clinical tests, the device herein mentioned is as safe, as effective, and performs as well as the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

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

June 2, 2014

Shijiazhuang Hongzan Plastic Technology Company, Limited C/O Ms. Kathy Liu Official Correspondent Hongray USA Medical Products Incorporated 3973 Schaefer Avenue Chino, CA 91710

Re: K133478

Trade/Device Name: Powder Free Polyethylene Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 19, 2014 Received: April 30, 2014

Dear Ms. Liu:

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 - Ms. Liu

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 (2) 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/ResourcesforYou/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.ida.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. 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) K133478

Device Name

Powder Free Polyethylene Examination Gloves

Indications for Use (Describe)

A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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FORM FDA 3881 (9/13)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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. . . .

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.