Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

Device Description

The proposed device is Powder Free Examination Gloves. The proposed device is Clear (non-colored). The proposed device is non-sterile.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what's available and noting what's not:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria	Reported Device Performance (K191292)
Dimensions - Length	ASTM D 5250-06 (Reapproved 2011): ≥ 230mm	233-241mm
Dimensions - Width	ASTM D 5250-06 (Reapproved 2011):Small 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm	84-88 mm94-98 mm103-109 mm114-117 mm
Dimensions - Thickness	ASTM D 5250-06 (Reapproved 2011):Fingertip ≥0.05mmPalm ≥0.08mm	Fingertip: 0.08-0.11mmPalm: 0.10-0.11mm
Physical Properties (Tensile Strength)	ASTM D 5250-06 (Reapproved 2011): ≥11MPa (Before & After aging)	15-17 MPa (for "Physical Properties")
Physical Properties (Elongation Rate)	ASTM D 5250-06 (Reapproved 2011): ≥300% (Before & After aging)	350-390% (for "Physical Properties")
Freedom from Pinholes	ASTM D5151-06 (Reapproved 2011): Holes at Inspection Level I, AQL2.5, Act/Re: 10/11	Water leakage test: 3 noncompliance is allowed (This is a different test/criterion reported in the comparison table, but within the "similar" category for pinholes). The detailed result for the ASTM D5151-06 specific criterion is not explicitly stated as "Pass" or "Fail" in the result column, but the overall "similar" comparison implies conformity.
Powder Residual	ASTM D6124-06 (Reaffirmation 2011): <2mg/glove	Mean: 0.1mg/pcs
Biocompatibility - Primary Skin Irritation	ISO 10993-10: 2010-08-01: Non-irritant or non-sensitizer (from predicate)	PassesUnder the conditions of the study, the subject device is not a skin sensitizer. (This result is specifically for dermal sensitization, not explicitly primary skin irritation. However, the predicate's acceptance criteria covers "non-irritant or non-sensitizer".)
Biocompatibility - Dermal Sensitization	ISO 10993-10: 2010-08-01: Dermal sensitization in the guinea pigs	PassesUnder the conditions of the study, the subject device is not a skin sensitizer.
Biocompatibility - Cytotoxicity	ISO 10993-5: 2009: Non-cytotoxicity to L-929 cells (from predicate, implied)	PassUnder the conditions of this study, the test article was non-cytotoxicity to L-929 cells.

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

Sample Size: Not explicitly stated for each test, but quantities like "Checked on 5pcs sub-samples (N=5)" are mentioned for "Residual Powder." "Inspection Level I AQL2.5" is an AQL (Acceptance Quality Limit) sampling plan, implying a specific sample size based on the lot size, but the exact number of units tested is not provided.
Data Provenance: The studies were non-clinical tests performed by Anhui Powerguard Technology Co.,Ltd, likely in China (country of origin of the manufacturer). The studies are retrospective in the sense that they were conducted specifically for this 510(k) submission, not ongoing clinical trials.

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):

This device is a medical glove undergoing non-clinical performance testing. The "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO). Therefore, "experts" in the context of clinical interpretation or diagnosis are not relevant here. The "experts" would be the scientists and engineers conducting the tests according to the standard protocols. Their qualifications are not detailed.

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

Not applicable. This is not a study involving human interpretation or adjudication of results in the way described (e.g., radiologists reviewing images). Performance is measured against physical and chemical 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:

No, an MRMC study was not done. This device is a medical glove, not an AI or diagnostic imaging device.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" for the device's performance is defined by the acceptance criteria of recognized international standards (ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-5, ISO 10993-10). These standards specify the test methods and the acceptable range of performance for each characteristic (e.g., tensile strength, elongation, freedom from pinholes).

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

Summary

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November 5, 2019

Anhui Powerguard Technology Co.,Ltd % Chu Xiaoan Official Correspondent Beijing Easylink CO., LTD Rm. F302 Bldg., 41, Jing Cheng Ya Ju Courtyard 6 of Southern Dou Ge Zhuang Beijing, 100021 Cn

Re: K191292

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: September 27, 2019 Received: October 7, 2019

Dear Chu Xiaoan:

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.

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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)

K191292

Device Name

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

Indications for Use (Describe)

	Type of Use (Select one or both, as applicable)
--	-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) Summary

K191292

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92

1.0 Submitter:

Submitter's name:	Anhui Powerguard Technology Co.,Ltd
Submitter's address:	North Development Zone, Lingbi County,Suzhou City, Anhui Province,234200, China
Name of contact person:	Mr. Nike Dai
Date of preparation:	2019-11-05

Designated Submission Correspondent

Company's name	Beijing Easy-Link Company
Company's address	Rm. F302 Bldg., 41, Jing Cheng Ya Ju,Courtyard 6 of Southern Dou Ge Zhuang,Chaoyang District, Beijing 100121, P.R.China
Contact person	Chu Xiaoan
Name of the Device

Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Proprietary/Trade name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Common Name: Exam gloves Classification Name: Patient examination glove Device I Regulation Number: 21 CFR 880.6250 Panel: General Hospital LYZ Product Code:

3.0 Predicate device

2.0

Device Name:	Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)
Company name:	Zhang Jia Gang Fengyuan Plastic Product Co. Ltd.
510(K) Number:	K091663

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4.0 Device Description:

The proposed device is Powder Free Examination Gloves. The proposed device is Clear (non-colored). The proposed device is non-sterile.

5.0 Indications for Use Statement:

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

6.0 Technological Characteristic Comparison Table:

Features &Description	Predicate Device(K091663)	Subject Device(K191292)	Comparison
Product name	Powder Free VinylPatient ExaminationGloves, Clear(non-colored)	Powder Free VinylPatient ExaminationGloves, Clear(non-colored)	Same
RegulationNumber	21CFR880.6250	21CFR880.6250	same
Product Code	LYZ	LYZ	same
Color	Clear(non-colored)	Clear(non-colored)	same
Size	Small/ Medium/Large/X large	Small/ Medium/Large/X large	same
Indications forUse	Powder Free VinylPatient ExaminationGloves, Clear (non-colored) is adisposable deviceintended for medicalpurposes that is wornon the examiner's handor finger to preventcontamination betweenpatient and examiner.	Powder Free VinylPatient ExaminationGloves, Clear (non-colored) is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand orfinger to preventcontamination betweenpatient and examiner.	same
DeviceDescription andSpecifications	Meets ASTM D5250-06	Meets ASTM D5250-06(Reapproved 2011)	Same
Dimensions --LengthILS-2AQL4.0	Meets ASTM D5250-06$\geq$ 230mm min	233 mm min for allsizes	Similar
Dimensions -- WidthIL S-2AQL4.0(mm)	Meets ASTM D5250-06Small 80-90Medium 90-100Large 100-110X large 110-120	Small 84-88Medium 94-98Large 103-109X large 114-117	Similar

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Dimensions			Similar
--ThicknessIL S-2AQL4.0	Meets ASTM D5250-06Finger 0.05mm min.Palm 0.05mm min.	Thickness (mm) min.Finger 0.08Palm 0.10
PhysicalPropertiesIL S-2AQL4.0	Meets ASTM D5250-06Before aging/after agingTensile Strength≥11MPaElongation ≥300%	15-17 MPa350-390%	Similar
Freedom fromPinholesInspection LevelI AQL2.5	Meets• 21 CFR 800.20• ASTM D6319-10	1) Inspection Level IAQL2.5,andAccept/Rejectcriteria of 10/112) Water leakage test:3 noncomplianceis allowed.	similar
ResidualPowder	Meets ASTMD 6124-06(Reaffirmation 2011)below 2mg of residualpowder	1) Checked on 5pcssub-samples(N=5).2) Result asfollowing:Mean: 0.1mg/pcs	similar
Materials usedto fabricate thedevices	PVC	PVC	same
Single PatientUse	Single Patient Use	Single Patient Use	same
Biocompatibility	Under the conditionsof this study, the testarticle was a non-irritant or non-sensitizer	Under the conditionsof this study, the testarticle was a non-irritant or non-sensitizerUnder the conditionsof this study, the testarticle was non-cytotoxicity to L-929cells.	similar
Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed.	-Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot- Clear(non-colored)- Non sterile	-Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot- Clear(non-colored)- Non sterile	same

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7.0 Discussion of Non-clinical Testing

Non-clinical tests were conducted to verify that the proposed device will meet acceptance crtiteria for each test. The test results demonstrated that the proposed device met the acceptance criteria found in the following standards below:

Name of Test	Purpose	Acceptance Criteria	Result
Dimension	MeetASTM D 5250-06(Reapproved 2011).	Length	≥230mm	233-241mm
		Width	Small 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm	84-88 mm94-98 mm103-109 mm114-117 mm
		Thickness	Fingertip ≥0.05mmPalm ≥0.08mm	0.08-0.11mm0.10-0.11mm
	PhysicalProperties	MeetASTM D 5250-06(Reapproved 2011).	(Before & After aging)Tensile strength ≥11MPaElongated rate ≥300%
	Freedom frompinholes	MeetASTM D5151-06(Reapproved 2011)	Holes at Inspection Level IAQL2.5Act/Re:10/11
	Powder Residual	MeetASTM D6124-06(Reaffirmation 2011)	<2mg/glove
	Biocompatibility	MeetISO 10993-10: 2010-08-01	Primary Skin Irritation in rabbits
	MeetISO 10993-10: 2010-08-01	Dermal sensitization in the guineapigs		PassesUnder the conditions ofthe study, the subjectdevice is not a skinsensitizer.
	MeetISO 10993-5: 2009	The test article was added to L929cells measured by MTT assay		PassUnder the conditions ofthis study, the testarticle was non-cytotoxicity to L-929cells

8.0 Discussion of Clinical and Performance Testing

Clinical testing is not needed for this device.

9.0 Conclusion

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