Disposable Powder Free Polyethylene Examination Gloves are powder free and non-sterile disposable devices intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

The Disposable Powder Free Polyethylene Examination Gloves are non-sterile disposable patient examination glove. The gloves are made of translucent (clear), low density polyethylene material and are powder free. The Disposable Powder Free Polyethylene Examination Gloves come in four sizes: Small, Medium, Large, X Large. The Disposable Powder Free Polyethylene Examination Gloves act as a barrier to prevent contamination between patient and examiner. The physical and performance characteristics of the device meets all requirements of ASTM D5250 and ASTM D5151.

AI/ML Overview

This document is a 510(k) Premarket Notification for Disposable Powder Free Polyethylene Examination Gloves, seeking substantial equivalence to a predicate device. As such, the presented information pertains to the performance testing of these physical medical gloves, not an AI/software device. Therefore, many of the requested categories related to AI/software performance (e.g., ground truth, expert adjudication, MRMC studies) are not applicable.

Here's an analysis of the provided text in relation to the prompt:

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

Characteristics	Standard	Acceptance Criteria	Reported Device Performance (Result)
Dimension	ASTM D 5250-19	Length ≥ 230mm	Pass, the test results meet the acceptance criteria.
		Width: Small 85±5mm, Medium 95±5mm, Large 105±5mm, X large 115±5mm
		Thickness: Finger ≥ 0.08mm, Palm ≥ 0.08mm
Physical Properties	ASTM D 5250-19	Before Aging: Tensile strength ≥11MPa, Ultimate elongation ≥300%	Pass, the test results meet the acceptance criteria. (Tensile strength > 11MPa, elongated rate > 300%)
		After Aging: Tensile strength ≥11MPa, Ultimate elongation ≥300%
Freedom from pinholes	ASTM D5250-19, ASTM D5151-19	Do not show droplet, stream or other type of water leakage at Inspection Level I AQL2.5	Pass, no leakage.
Powder Residual	ASTM D5250-19, ASTM D6124-06 (Reapproved 2017)	Less than 2.0mg/glove	Pass, the test results meet the acceptance criteria.
In vitro cytotoxicity	ISO 10993-5	The test article should not have potential toxicity to L-929 in the MTT method.	Pass, the test article has no potential toxicity to L-929 in the MTT method.
Skin sensitization	ISO 10993-10	The test article should not cause delayed dermal contact sensitization in the guinea pig.	Pass, the test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article has no potential skin sensitization on guinea pigs in the extraction method.
Skin irritation	ISO 10993-10	The irritation response category in the rabbit should be negligible.	Pass, the response of the test article extract was categorized as negligible under the test condition. The test article has no potential skin irritation on rabbit in the extraction method.

2. Sample sizes used for the test set and the data provenance:

The document does not explicitly state the exact sample sizes (number of gloves) used for each specific test (e.g., how many gloves were tested for pinholes, how many for tensile strength).
The data provenance is from non-clinical tests performed by a qualified test center on the manufactured gloves. The country of origin of the data is not explicitly stated, but the applicant company is Mastermax Plastic (Huizhou) LTD in China. The tests are "retrospective" in the sense that they were performed on product samples, not a prospective clinical trial.

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

This question is not applicable as the document describes performance testing for physical medical gloves, not an AI/software device that requires human expert interpretation or ground truth establishment in the traditional sense for a test set. The "ground truth" here is the physical measurement or biological response according to established international standards (ASTM, ISO).

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

This question is not applicable. Adjudication methods are typically relevant for human interpretation or consensus in AI/software performance studies. The testing described involves objective measurements against predefined 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:

This question is not applicable. The device is a physical product (examination gloves), not an AI-assisted diagnostic tool.

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

This question is not applicable. The device is a physical product.

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

For this physical device, the "ground truth" is established by adherence to internationally recognized performance standards and their specified test methodologies. These standards (ASTM International, ISO) define precise measurements and acceptable ranges for physical properties (dimensions, tensile strength, elongation, powder residual, freedom from pinholes) and biocompatibility (cytotoxicity, irritation, sensitization).

8. The sample size for the training set:

This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The product undergoes manufacturing quality control and subsequent batch testing against established specifications.

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

This question is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

May 31, 2022

Mastermax Plastic (Huizhou) LTD % Tracy Che Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Oianhai Road Shenzhen, Guangdong 518100 China

Re: K212699

Trade/Device Name: Disposable Powder Free Polyethylene Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: April 26, 2022 Received: May 2, 2022

Dear Tracy Che:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212699

Device Name

Disposable Powder Free Polyethylene Examination Gloves

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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K212699

510k Summary

This 510(k) Summary is submitted in accordance with requirements of Title 21, CFR Section 807.92.

(1) Applicant information:

510(k) owner's name:	Mastermax Plastic (Huizhou) LTD
Address:	No.1, Qingli 3rd Road, Shuikou, Huicheng district, Huizhou,Guangdong, China
Contact person:	Benson Xu
Phone number:	+86-752-2315076
Email:	Bensonmastermax1@126.com
Date of summary prepared:	2022-5-24

(2) Proprietary name of the device

Trade name/model:	Disposable Powder Free Polyethylene Examination Gloves
Common name:	Polymer Patient Examination Glove
Regulation number:	21 CFR 880.6250
Product code:	LZA
Review panel:	General Hospital
Regulation class:	Class I

(3) Predicate device

Sponsor	Jiangsu U-MED Rubber & Plastic Products Co.,Ltd.
Device Name and Model	U-MED Powder Free Polyethylene Examination Gloves, Blue Color
510(k) Number	K173228
Product Code	LZA
Regulation Number	21 CFR 880.6250
Regulation Class	Class I

(4) Description/ Design of device:

The Disposable Powder Free Polyethylene Examination Gloves act as a barrier to prevent

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contamination between patient and examiner. The physical and performance characteristics of the device meets all requirements of ASTM D5250 and ASTM D5151.

(5) Indications for use:

Item	Subject device	Predicate device	Comparison
Company	Mastermax Plastic (Huizhou) LTD	Jiangsu U-MED Rubber &Plastic Products Co.,Ltd	/
Trade name	Disposable Powder FreePolyethylene ExaminationGloves	U-MED Powder FreePolyethylene ExaminationGloves, Blue Color	/
510 (k) number	K212699	K173228	/
Regulationnumber	21CFR 880.6250	21 CFR 880.6250	Same
Product code	LZA	LZA	Same
Size	Small/ Medium/ Large/X large	Small/ Medium/ Large/X large	Same
Class	I	I	Same
Indications foruse / Intendeduse	Disposable Powder FreePolyethylene ExaminationGloves are powder free andnon-sterile disposable devicesintended for medical purposesthat are worn on theexaminer's hand or finger toprevent contaminationbetween patient and examiner.	Powder Free PolyethyleneExamination Gloves, BlueColor is a non-steriledisposable device intended formedical purposes that is wornon the examiner's hand orfinger to preventcontamination between patientand examiner.	Similar
DeviceDescription andSpecifications	Meets ASTM D5250-19	Meets ASTM D5250-06(Reapproved 2015)	Similar
Dimensions:Overall length,Width,Palm and Fingerthickness	Meets ASTM D5250-19	Meets ASTM D5250-06(Reapproved 2015)	Similar
Item	Proposed device	Predicate device	Remark
PhysicalPropertiesTensile Strengthbeforeaging/afteraging	Meets ASTM D5250-19	Meets ASTM D5250-06(Reapproved 2015)	Similar
UltimateElongationbeforeaging/afteraging	Meets ASTM D5250-19	Meets ASTM D5250-06(Reapproved 2015)
Freedom fromPinholesHoles	Holes atInspection Level IAQL2.5	Holes atInspection Level IAQL2.5	Same
ResidualPowder	Meets ASTM D5250-19	Meets ASTM D5250-06(Reapproved 2015)	Similar
Materials usedto fabricate thedevices	Polyethylene	Polyethylene	Same
Color	Translucent [clear]	Blue color	Different
PerformanceData Standard	Meets ASTM D5151-19ASTM D5250-19ASTM D6124-06(Reapproved 2017)	Meets ASTM D5151-06(Reapproved 2015)ASTM D5250-06(Reapproved 2015)ASTM D6124-06(Reaffirmation 2011)	Similar
Single PatientUse	Single Patient Use	Single Patient Use	Same
Biocompatibility	Under the conditions of thisstudy, not have cytotoxicityandUnder the conditions of thisstudy, not an irritant andUnder the conditions ofthis	Under the conditions of thisstudy, not an irritant and Underthe conditions of this study,not a sensitizer.SKIN IRRITATION	Similar
Item	Proposed device	Predicate device	Remark
	study, not a sensitizer.SKIN IRRITATIONand SENSITIZATIONSTUDIES Meet ISO10993-10: 2010In Vitro Cytotoxicity MeetsISO 10993-5: 2009	DERMAL andSENSITIZATION STUDIESMeets ISO 10993-10 ThirdEdition 2010-08-01
	Labeling	There are no special labelingclaims and we do not claimour gloves as hypoallergenicon our labels.-Powder Free-Patient Examination Glove-Single Use Only-LotShelf life of 3 years	There are no special labelingclaims and we do not claimour gloves as hypoallergenicon our labels.-Powder Free-Patient Examination Glove-Single Use Only- Manufactured For:- Lot	Similar

(6) Technological Characteristics Comparison:

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(7) Summary of the Technological Characteristics of the Device:

Disposable Powder Free Polyethylene Examination Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standard.

Characteristics	Standard
Dimension	ASTM D 5250-19
	Length $\geq$ 230mm
	Width
	Small 85±5mm
	Medium 95±5mm
	Large 105±5mm
	X large 115±5mm
	Thickness
	Finger $\geq$ 0.08mm
	Palm $\geq$ 0.08mm
Physical Properties	ASTM D 5250-19
	Tensile strength (Before & After aging) $\geq$ 11MPa
	Elongated rate (Before & After aging) $\geq$ 300%
Freedom from pinholes	● ASTM D5250-19 Passed Standard● ASTM D5151-19 Acceptance Criteria
Powder Residual	ASTM standard D5250-19 and D6124-06(Reapproved 2017) Meets <2mg/glove
Biocompatibility	In Vitro Cytotoxicity MTT method ISO 10993-5: 2009 PassUnder the experimental conditions, the test

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		article has no potentialtoxicity to L-929 in theMTT method.
	Skin Irritation in rabbits ISO 10993-10: 2010	PassUnder the experimentalconditions, the testarticle has no potentialskin irritation on rabbit inthe extraction method.
	Skin sensitization in the guinea pig ISO10993-10: 2010	PassUnder the experimentalconditions, the testarticle has no potentialskin sensitization onguinea pigs in theextraction method.

(8) Non-Clinical Performance Data:

The Disposable Powder Free Polyethylene Examination Gloves meet requirements per ASTM D5250-19, per ASTM D 5151-19, per ASTM D6124-06 (Reapproved 2017), ISO 10993-5: 2009 and ISO 10993-10: 2010.

Those verification tests of gloves were performed by qualified test center according to the above standards and included dimensions, tensile strength (before & after aging) & elongated rate (before & after aging), powder residual, water leak testing, and biocompatibility. The overall results of the testing demonstrated that the subject glove passed testing performed according to ASTM D5250-19. Tensile strength (Before & After aging) was demonstrated as more than 11MPa, elongated rate (before & after aging) was demonstrated as more than 300%, powder residual was demonstrated as less than 2mg/glove. The subject glove also did not raise any biocompatibility concerns when tested according to ISO 10993-5 and ISO 10993-10. The detailed information for the non-clinical testing performed can be seen in corresponding test reports and are summarized as the following table.

Test Method	Purpose	Acceptance criteria	Results
DimensionASTM D 5250-19	To evaluate thephysical dimension ofthe gloves.	Length: $\geq$ 230mm;Width:Small 85 $\pm$ 5mmMedium 95 $\pm$ 5mmLarge 105 $\pm$ 5mmX large 115 $\pm$ 5mm;Thickness: $\geq$ 0.08mm	Pass, the test resultsmeet the acceptancecriteria.
		(finger, palm)
PhysicalPropertiesASTM D 5250-19	To evaluate thephysical properties(tensile strength andelongated rate before& after aging).	Before AgingTensile strength: ≥11MPaUltimate elongation: ≥300%;After AgingTensile strength: ≥11MPaUltimate elongation: ≥300%	Pass, the test resultsmeet the acceptancecriteria.
Freedom frompinholesASTM D5250-19ASTM D5151-19	Detection of the holesthat allow waterleakage.	Do not show droplet,stream or other type ofwater leakage atInspection Level IAQL2.5	Pass, no leakage.
Powder ResidualASTM D5250-19ASTM D6124-06(Reapproved2017)	To evaluate theresidual powder.	Less than 2.0mg/glove	Pass, the test resultsmeet the acceptancecriteria.
In vitrocytotoxicity ISO10993-5	To evaluate thebiological safety of theproduct which hasdirect contact withintact skin.	The test article should nothave potential toxicity toL-929 in the MTTmethod.	Pass, the test articlehas no potentialtoxicity to L-929 inthe MTT method.
Skin sensitizationISO 10993-10	To evaluate thebiological safety of theproduct which hasdirect contact withintact skin.	The test article should notcause delayed dermalcontact sensitization in theguinea pig.	Pass, the test articleshowed no evidenceof causing delayeddermal contactsensitization in theguinea pig. The testarticle has nopotential skinsensitization onguinea pigs in theextraction method.
Skin irritation	To evaluate the	The irritation response	Pass, the response of
ISO 10993-10	biological safety of theproduct which hasdirect contact withintact skin.	category in the rabbitshould be negligible.	the test article extractwas categorized asnegligible under thetest condition. Thetest article has nopotential skinirritation on rabbit inthe extraction method.

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(9) Clinical data

Clinical performance testing was not needed for this device.

(10) Conclusion

Based on the nonclinical tests performed, the subject device, Disposable Powder Free Polyethylene Examination Gloves, are as safe, as effective, and perform as well as or better than the legally marketed predicate device, K173228, U-MED Powder Free Polyethylene Examination Gloves, Blue Color.

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.