The Powder Free Vinyl Patient Examination Gloves (Green) 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 Vinyl Patient Examination Gloves (Green) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011)--Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.

AI/ML Overview

The provided text describes the submission for a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves (Green)". This document type does not include information about AI/ML device performance or large-scale comparative effectiveness studies involving human readers, as it pertains to a Class I medical device (patient examination gloves). The "acceptance criteria" and "study" described herein are related to the physical and chemical properties of the gloves, demonstrating their substantial equivalence to a predicate device.

Therefore, many of the requested fields regarding AI/ML device performance, human reader studies, and AI-specific ground truth establishment cannot be answered from the provided text.

Here's a breakdown of the available information regarding the glove's acceptance criteria and the study proving it meets these criteria:

Device Name: Powder Free Vinyl Patient Examination Gloves (Green)
Device Type: Patient Examination Glove (Class I Medical Device)
Regulation Number: 21 CFR 880.6250

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents a comparison between the subject device and a predicate device (Tangshan Hongyun Plastic Products Company Limited Powder-Free Yellow Vinyl Patient Examination Gloves, K141878) against various standards.

Characteristic	Standard	Acceptance Criteria (Predicate Device)	Reported Device Performance (Subject Device)	Result of Comparison
General
Product Code		LYZ	LYZ	Same
Intended Use		Non-sterile disposable for medical purposes, worn on hand/finger to prevent contamination.	Non-sterile disposable for medical purposes, worn on hand/finger to prevent contamination.	Same
Size		S/M/L/XL	S/M/L/XL	Same
Materials Used		PVC	PVC	Same
Dusting or Donning Powder		PU	PU	Same
Single Patient Use	/	Single patient use	Single patient use	Similar
Physical Properties
Dimensions: Length	ASTM D 5250-06 (2011)	Meets 230 mm min for all sizes	Meets 230 mm min for all sizes	Similar
Dimensions: Width	ASTM D 5250-06 (2011)	S: 83-86 mm, M: 94-97 mm, L: 104-107 mm, XL: 113-115 mm	S: 85±5 mm, M: 95±5 mm, L: 105±5 mm, XL: 115±5 mm	Similar
Dimensions: Thickness	ASTM D 5250-06 (2011)	Palm: 0.08 mm min, Finger: 0.05 mm min	Palm: 0.08 mm min, Finger: 0.05 mm min	Similar
Tensile Strength (before/after aging)	ASTM D 5250-06 (2011)	≥11 MPa	≥11 MPa	Similar
Elongation (before/after aging)	ASTM D 5250-06 (2011)	≥300%	≥300%	Similar
Freedom from Pinholes	ASTM D 5250-06 (2011), ASTM D5151-06 (Reapproved 2011)	G-I, AQL 2.5	G-I, AQL 2.5	Similar
Residual Powder	ASTM D 5250-06 (2011), ASTM D6124-06 (Reaffirmation 2011)	Below 2mg of residual powder	Not more than 2mg per glove	Similar
Biocompatibility
Skin Irritation	ISO 10993-10	Not an irritant	Not an irritant	Same
Sensitization	ISO 10993-10	Not a sensitizer	Not a sensitizer	Same
Performance Data
ASTM Standards Met		ASTM D5151-06(2011), ASTM D 5250-06 (2011), ASTM D6124-06(2011)	ASTM D5151-06(2011), ASTM D 5250-06 (2011), ASTM D6124-06(2011)	Same

The acceptance criteria are generally "Meets" the specified ASTM standards and biocompatibility results (e.g., "not an irritant"). The reported device performance indicates that the subject device also meets these criteria, supporting substantial equivalence.

2. Sample Size Used for the Test Set and the Data Provenance:

The document states that the physical and performance characteristics meet "all requirements of ASTM D5250-06 (Reapproved 2011)". This implies that standard testing methodologies as defined by these ASTM standards were followed. However, the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, tensile strength, etc.) are not explicitly provided in this summary.

Data Provenance: The testing was conducted by Supermax Plastic Products Co., Ltd. in China (Hebei Province). The data is non-clinical testing performed to support substantial equivalence. It is inherently retrospective in the context of the 510(k) submission, as these tests would have been completed prior to submission.

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 product testing scenario, not a study requiring expert clinical labeling or ground truth establishment in the context of AI/ML. The "ground truth" here is determined by objective measurements against established ASTM and ISO standards by qualified testing personnel.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study requiring adjudication of expert opinions. Device performance is measured against objective, standardized criteria.

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 document pertains to patient examination gloves, not an AI-assisted diagnostic device.

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

Not applicable. This document pertains to patient examination gloves, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device is based on objective, standardized measurements against the specifications outlined in relevant industry standards, specifically:

ASTM D 5250-06 (2011) - Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application
ASTM D5151-06 (2011) - Standard Test Method For Detection Of Holes In Medical Gloves
ASTM D6124-06 (2011) - Standard Test Method For Residual Powder On Medical Gloves
ISO 10993-10 (third edition 2010-08-01) - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
21 CFR 800.20 - General requirements for device labeling

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no training set in that context. The "training" for manufacturing would be industrial process control, not data training.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no AI/ML training set. The manufacturing processes would be subject to quality control and good manufacturing practices (GMP) to ensure the product meets specifications.

Summary

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

December 21, 2015

Supermax Plastic Products Co., Ltd % Ms. Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Ave. Chino, California 91710

Re: K152692

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves (Green) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 24, 2015 Received: November 27, 2015

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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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 and Part 809); medical device 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.

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,

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) K152692

Device Name

Powder Free Vinyl Patient Examination Gloves (Green)

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)

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

FOR FDA USE ONLY

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

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Supermax Plastic Products Co., Ltd.

314 Dragon River East Road, Luquan, Hebei Province, CHINA 050000

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: K152692

1. Owner's Identification :

Mr. Wu Zhigang Supermax Plastic Products Co., Ltd. 314 Dragon River East Road, Luquan, Hebei Province, 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: December 15, 2015

2. Name of the Device:

Trade Name: Powder Free Vinyl Patient Examination Gloves (Green) Common Name: Patient Examination Gloves Classification Name: Patient Examination Glove Classification Regulation: 21 CFR 880.6250 Classification Panel: 80 General Hospitals Product Code: LYZ Device Class: Class I

3. Predicate Device Information:

Tangshan Hongyun Plastic Products Company Limited Powder-Free Yellow Vinyl Patient Examination Gloves (K141878)

4. Device Description:

5. Intended Use of the Device:

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Supermax Plastic Products Co., Ltd.

314 Dragon River East Road, Luquan, Hebei Province, CHINA 050000

6. Technological Characteristics and Substantial Equivalence:

Supermax Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves (Green) is substantially equivalent in safety and effectiveness to the Tangshan Hongyun Plastic Products Company Limited's Powder-Free Yellow Vinyl Patient Examination Gloves (K141878). 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:

Characteristics	Standard	Device Performance		Result of
		Predicate device	Subject Device	comparison
510K number		K141878	K152692	--
Product name	1	Powder-Free Yellow VinylPatient ExaminationGloves	Powder Free VinylPatient ExaminationGloves (Green)	Similar
Product Code		LYZ	LYZ	Same
Intended Use		Powder-Free Yellow VinylPatient ExaminationGloves is a non steriledisposable device intendedfor medical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner.	The Powder Free VinylPatient ExaminationGloves (Green) isdisposable non-steriledevice intended formedical purpose that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner.	Same
Size		S/M/L/XL	S/M/L/XL	Same
Compare allmaterials usedto fabricate thedevices		PVC	PVC	Same
Dusting orDonningpowder		PU	PU	Same
Compareperformancedata supportingsubstantialequivalence		MeetsASTM D5151-06(2011)ASTM D 5250-06 (2011)ASTM D6124-06(2011)	MeetsASTM D5151-06(2011)ASTM D 5250-06 (2011)ASTM D6124-06(2011)	Same
Color		Yellow	Green	Similar
	Standard	Device Performance		Result of
Characteristics		Predicate device	Subject Device	comparison
Single patientuse	/	Single patient use	Single patient use	Similar
Dimensions:Length	ASTM D 5250-06 (2011)	Meets230 mm min for all sizes	Meets230 mm min for all sizes	Similar
Dimensions:Width	ASTM D 5250-06 (2011)	MeetsS: 83-86 mmM: 94-97 mmL: 104-107 mmXL: 113-115 mm	MeetsS: 85±5 mmM: 95±5 mmL: 105±5 mmXL: 115±5 mm	Similar
Dimensions:Thickness	ASTM D 5250-06 (2011)	MeetsPalm: 0.08 mm minFinger: 0.05 mm min	MeetsPalm: 0.08 mm minFinger: 0.05 mm min	Similar
Tensilestrength:beforeandafter aging	ASTM D 5250-06 (2011)	MeetsTensile Strength≥11MPa	MeetsTensile Strength≥11MPa	Similar
Elongationbefore and afteraging	ASTM D 5250-06 (2011)	MeetsElongation≥300%	MeetsElongation≥300%	Similar
Freedom frompinholes	ASTM D 5250-06 (2011)ASTM D5151-06(Reapproved2011)	MeetsG-I, AQL2.5	MeetsG-I, AQL2.5	Similar
Residualpowder	ASTM D 5250-06 (2011)ASTM D6124-06(Reaffirmation 2011)	MeetsResults below 2mg ofresidual powder	MeetsNot more than 2mg perglove	Similar
Biocompatibility	Skin irritationISO 10993-10	Under conditions ofthestudy, not an irritant	Under conditions of thestudy, not an irritant	Same
	SensitizationISO 10993-10	Under the conditions of thestudy, not a sensitizer	Under the conditions ofthe study, not a sensitizer	Same
Labeling	/	Powder FreeDevices color: YellowPatient examination GloveNon SterileSingle use onlyManufactured for:Lot	Powder FreeDevices color: GreenPatient examinationGloveNon Sterile Singleuse onlyManufactured for:Lot	Similar

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Supermax Plastic Products Co., Ltd.
314 Dragon River East Road, Luquan, Hebei Province, CHINA 050000

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Supermax Plastic Products Co., Ltd.

314 Dragon River East Road, Luquan, Hebei Province, CHINA 050000

Powder Free Vinyl Patient Examination Gloves (Green) shares the same or comparable 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 is as Follows:

Powder Free Vinyl Patient Examination Gloves (Green) meet requirements per ASTM D 5250-06(2011), per ASTM D6124-06 (2011), ASTM D5151-06(2011), 21CFR 800.20 and ISO 10993-10 third edition 2010-08-01

8. Discussion of Clinical Tests Performed:

Clinical data was not included in the submission. Substantial equivalence of the subject device was supported by non-clinical testing.

9. Conclusions:

Powder Free Vinyl Patient Examination Gloves (Green) 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.

Drawn from the complete list of non-clinical tests, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device. The subject device is 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.