Disposable Nitrile Examination Gloves 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.

Device Description

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.

AI/ML Overview

The provided text describes the non-clinical testing performed for a Class I medical device, "Disposable Nitrile Examination Gloves" (K211073). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the efficacy of an AI/ML algorithm. Therefore, many of the requested bullet points, particularly those related to AI algorithm performance, human-in-the-loop studies, and ground truth establishment for training sets, are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and study results for this specific device.

Acceptance Criteria and Device Performance for Disposable Nitrile Examination Gloves (K211073)

The provided document details non-clinical tests conducted to verify the safety and performance of the "Disposable Nitrile Examination Gloves" (K211073) against established standards and to demonstrate substantial equivalence to a predicate device (K181106).

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance (Results)
In Vitro Cytotoxicity Test (Agar diffusion Method) (ISO 10993-5:2009)	Determine potential cytotoxicity to mammalian cell cultures (mouse fibroblast L-929 cells).	The test sample met the requirements if the biological response was less than or equal to grade 2.	Under the conditions of this study, the test article was Slight cytotoxic and was accepted in the agar diffusion method.
Skin Sensitization Test (Guinea Pig Maximization) (ISO 10993-10:2010)	Evaluate potential for the test article to cause skin sensitization.	Magnusson and Kligman grades of 1 or greater in the test group generally indicate sensitization, provided grades of less than 1 are seen in control animals. If grades of 1 or greater are noted in control animals, then the reactions of test animals which exceed the most severe reaction in control animals are presumed to be due to sensitization. If the response is equivocal, rechallenge is recommended to confirm the results from the first challenge. The outcome of the test is presented as the frequency of positive challenge results in test and control animals.	The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.
Skin Irritation Test (Extraction Method) (ISO 10993-10:2010)	Evaluate potential skin irritation caused by test article contact with skin surface of rabbits.	When blank or negative control was used, calculate the primary irritation score for the controls and subtract that score from the score using the test material to obtain the primary irritation score.	The test result showed that the response of the test article extract was categorized as negligible under the test condition.
Acute Systemic Toxicity Test (Extraction Method) (ISO10993-11:2017)	Evaluate potential acute systemic toxicity caused by test article contact in ICR mice.	Within the monitoring period (72 h), if the toxicosis response of testing group is not greater than that of control group, the testing sample is regarded as acceptable. In case that two or more mice show the medium toxicosis symptom or die, the testing sample is regarded as unacceptable. If any animals treated with the sample show only slight signs of biological reactivity, and not more than one animal shows gross symptoms of biological reactivity or dies, repeat the testing using groups of 10 animals. On the repeat test, if all 10 animals treated with the sample show no scientifically meaningful biological reactivity above the vehicle control animals during the observation period, the sample meets the requirements of this test.	The test article showed no evidence of causing acute system toxicity in the ICR mice.
Watertightness Test for Detection of Holes (ISO 2859-1:1999, ASTM D6319-19, ASTM D5151-19)	Validate integrity of the glove to prevent holes.	Items: Water lack, Batch size: 35000, Inspectional level: I, AQL: 2.5, Sample Demand: 125, Criterion: ≤7 non-conforming gloves.	Number of Conforming: 125 Glove, Number of Non-conforming: 0 Glove
Physical Dimensions Test (ISO 2859-1:1999, ASTM D6319-19, ASTM D3767-03(2014)) (Includes Length, Width, Thickness as per Table 1)	Ensure dimensional conformity to standard (ASTM D6319-19).	Items: Physical dimension test, Batch size: 35000, Inspectional Level: S-2, AQL: 4.0, Sample Demand: 13. (Specific ranges for Length, Width, Thickness are provided in Table 1, and the acceptance indicates compliance with ASTM D6319-19 for these.)	The test result was considered to be acceptable. (Specific measurements are listed in Table 1, matching or exceeding ASTM D6319-19 requirements)
Determination of Physical Properties (ISO 2859-1:1999, ASTM D6319-19, ASTM D412-06a(2013)) (Includes Tensile Strength and Ultimate Elongation as per Table 1)	Validate mechanical properties of the glove (tensile strength, elongation) both before and after aging.	Items Before Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥500%. After Accelerated Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥400%. Batch size: 35000, Inspectional Level: S-2, AQL: 4.0, Sample Demand: 13, Number of Non-conforming: ≤1.	The test result was considered to be acceptable. (Specific measured ranges provided in Table 1: Before Aging Tensile Strength 15.3-23.4 MPa, Ultimate Elongation 500.972-595.086%; After Aging Tensile Strength 14.1-30.6 MPa, Ultimate Elongation 416.106-601.187%)
Surface Powder Test of "powder-free" gloves (ASTM D6319-19, ASTM D573-04(2015), ISO 21171-2006, ASTM D6124-06(2017))	Quantify residual powder on the gloves to ensure "powder-free" claim.	Analyte: Residual Powder, Powder-free Synthetic Exam (3 sets of 2 gloves/batch, Average: 0.63mg/glove - this appears to be a reference/predicate value or goal, as the acceptance isn't explicitly stated as a limit from the provided text).	Result: 0.18mg/glove. The results showed each property of the test glove was acceptable under this test condition.

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

Cytotoxicity, Skin Sensitization, Skin Irritation, Acute Systemic Toxicity: Sample sizes are not explicitly stated as numerical values for these biological tests but refer to "test article" which implies sufficient samples as per the respective ISO standards. The data provenance is not specified beyond being part of the submission for a Chinese manufacturer; presumably, the tests were conducted under controlled laboratory conditions, not on human patients or retrospectively/prospectively collected clinical data.
Watertightness Test:
- Sample Demand: 125 gloves
- Batch size: 35,000 gloves (for lot-by-lot inspection, implies the sample is drawn from a manufacturing lot)
- Provenance: Not specified, but generally implies in-house or contracted lab testing for manufacturing batches.
Physical Dimensions Test:
- Sample Demand: 13 gloves
- Batch size: 35,000 gloves
- Provenance: Not specified.
Determination of Physical Properties:
- Sample Demand: 13 gloves
- Batch size: 35,000 gloves
- Provenance: Not specified.
Surface Powder Test:
- Sample size: 5 sub-samples (N=5) as per Table 1 (page 5), although another section mentions "3 sets of 2 gloves/batch". The results section states "Mean: 0.18mg/glove" for a test on 5pcs sub-samples (N=5).
- Provenance: Not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not Applicable. This document describes non-clinical, laboratory-based physical and biological performance tests, not AI algorithm validation requiring expert human ground truth.

4. Adjudication Method for the Test Set

Not Applicable. This is not a human interpretation study. Acceptance is determined by meeting predefined numerical or qualitative criteria specified in the relevant ASTM/ISO 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 document pertains to the regulatory clearance of a physical medical device (examination gloves), not an AI/ML diagnostic tool. There is no AI component.

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

Not Applicable. No AI algorithm is involved.

7. The Type of Ground Truth Used

Objective Measurement and Standard Compliance: The "ground truth" for these tests is based on objective laboratory measurements (e.g., water leakage, dimensions, tensile strength, residual powder) and predefined biological responses in accordance with internationally recognized standards (ASTM, ISO). For biocompatibility, it's about whether the material elicits a specific biological reaction (e.g., cytotoxicity, irritation, sensitization).

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not an AI/ML device.

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

Not Applicable. There is no "training set" and therefore no ground truth establishment for it in this context.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.

September 21, 2021

Foshan Kangkang Biotechnology Co., LTD Yico Xie General Manager 2nd Floor, Building 4, Dongfang Industrial Park, Xiaotang Industrial Avenue, Shishan Town, Nanhai District Foshan City, Guangdong 528225 China

Re: K211073

Trade/Device Name: Disposable Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 4, 2021 Received: August 4, 2021

Dear Yico Xie:

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.

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

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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 mediation-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 Clarence W. Murray, III, PhD 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) K211073

Device Name

Disposable Nitrile Examination Gloves

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)

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510(k) Summary

K211073

Date of Summary Preparation: March 31, 2021 Date of Modification: July 23, 2021

1. Submitter's Identifications

Submitter's Name: FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD Address: 2nd Floor,Building 4,Dongfang Industrial Park, Xiaotang Industrial Avenue, Shishan Town, Nanhai District, Foshan City, Guangdong Province, China Contact Person: Yico Xie Contact Title: General Manager Contact E-mail Address: kangkang biotechnology(@aliyun.com Zip code: 528225 Telephone: +86-13702554142

2. Correspondent's Identifications

Correspondent's Name: FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD Address: 2nd Floor, Building 4, Dongfang Industrial Park, Xiaotang Industrial Avenue, Shishan Town, Nanhai District, Foshan City, Guangdong Province, China ZIP Code: 528225 Contact Person: Yico Xie Contact Title: General Manager Contact E-mail Address: Kangkangfda@126.com Telephone: +86-13702554142

3. Name of the Device

Device Classification Name: Non-powdered Patient examination glove Common Name: Polymer Patient Examination Glove Trade Name: Disposable Nitrile Examination Gloves Model/Size: S, M, L, XL Classification Panel: General Hospital Product Code: LZA Device Classification: Class I

4. The Predicate Devices

Powder Free Nitrile Patient Examination Gloves, Blue Color K181106

5. Device Description

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.

6. Indications for Use

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7. Summary of Technological Characteristics

	Proposed Device		Primary predicate device	Comparison
510k Number	K211073		K181106
Manufacturer	FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD		JiangSu DongXin Medical Technology Co., Ltd
ProprietaryName	Disposable Nitrile Examination Gloves		Powder Free Nitrile Patient Examination Gloves, Blue Color
RegulationNumber	21 CFR 880.6250		21 CFR 880.6250	Same
Product Code	LZA		LZA	Same
Color	Blue		Blue	Same
Size	S, M, L, XL		S, M, L, XL	Same
Indications forUse	Disposable Nitrile Examination Gloves 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.		Powder Free Nitrile Patient Examination Gloves, Blue Color 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.	Same
DeviceDescription andSpecifications	Meets ASTM D6319-19		Meets ASTM D6319-10	Same
Freedom fromPinholesIL I AQL2.5	1) Inspection 125pcs, Inspection Level I AQL2.5, and Accept/Reject criteria of 7/82) Water leakage test: 0 noncompliance.		1) Inspection Level I AQL2.5, and Accept/Reject criteria of 10/112) Water leakage test: 5 noncompliance is allowed.	Similar
Dimensions-LengthILS-2 AQL4.0	Meets ASTM D6319-19230mm min. for all sizes		232 mm min for all sizes	Similar
Dimensions-WidthIL S-2 AQL4.0	Meets ASTM D6319-19S 82-85mmM 93-97mmL 100-103mmXL 110-111mm		S 76-90mmM 89-102mmL 108-119mmXL 115-128mm	Similar
Dimensions-ThicknessIL S-2 AQL4.0	Meets ASTM D6319-19Thickness (mm) min.Finger: 0.13		Thickness (mm) min.Finger: 0.08Palm: 0.08	Similar
	Palm: 0.07
PhysicalPropertiesIL S-2 AQL4.0	Before Aging	After Aging	Before Aging	After Aging	Similar
Tensile Strength(MPa)	15.3-23.4	14.1-30.6	18-25	17-22	Similar
UltimateElongation (%)	500.972-595.086	416.106-601.187	550-600	450-570
Residual Powder	1) Checked on 5pcssub-samples (N=5).2) Result as following: Mean:0.18mg/glove		2) Checked on 5pcssub-samples (N=5).2) Result as following: Mean:0.1mg/pcs		Similar
Materials	Nitrile		Nitrile		Same
Single PatientUse	Single Patient Use		Single Patient Use		Same
Biocompatibility	Under the conditions of thisstudy, the test article was anon irritant or non sensitizer		Under the conditions of thisstudy, the test article was anon irritant or non sensitizer		Same
	Under the conditions of thisstudy, the test article wasslight cytotoxic to L-929 cellsand was accepted in the agardiffusion method.		Under the conditions of thisstudy, the test article was noncytotoxicity to L-929 cells.		Similar
	Under the conditions of thisstudy, the test article wasshowed no evidence of causing		Not publicly available		Different7
Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed	-Powder Free-Patient Examination Glove-Single Use Only- Manufactured For:- Lot-Blue color- Non sterile		-Powder Free-Patient Examination Glove-Single Use Only- Manufactured For:- Lot-Blue color- Non sterile		Same
Standard	ASTM D6319-19ASTM D6124-06(Reapproved 2017)ASTM D5151-19ISO 10993-5:2009ISO 10993-10:2010ISO 10993-11:2017		ASTMD6319-10(Reapproved 2015)ASTM D6124-06(Reapproved 2017)ASTMD5151-06(Reapproved2015)ISO 10993-5:2009ISO 10993-10:2010		Similar8

Table 1 Comparison to Predicate Device

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8. Summary of Non-Clinical Testing:

Non-clinical tests were conducted to verify that the proposed device met acceptance criteria

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for each test.

ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization

ISO10993-11:2017 Biological evaluation of medical devices - Part11: Tests for systemic toxicity, implemented test for acute system toxicity

ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application

ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves

ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves

Summary of the non-clinical testing is shown as below:

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FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD

Test Methodology	Purpose	Acceptance Criteria	Results
In Vitro Cytotoxicity Test:Agar diffusion Method	The purpose of the test is todetermine the potential cytotoxicitytoxicity of a mammalian cell culture(mouse fibroblast L-929 cells) inresponse to the test article.	The test sample met the requirements of the test if the biologicalresponse was less than or equal to grade 2.	Under the conditions ofthis study, the test articlewas Slight cytotoxic andwas accepted in the agardiffusion method.
Skin Sensitization Test:Guinea Pig Maximization	The test was designed to evaluatethe potential of a test article to causeskin sensitization. The test is used asa procedure for screening of contactallergens in guinea pigs andextrapolating the results to humans,but it does not establish the actualrisk of sensitization.	Magnusson and Kligman grades of 1 or greater in the test groupgenerally indicate sensitization, provided grades of less than 1are seen in control animals.If grades of 1 or greater are noted in control animals, then thereactions of test animals which exceed the most severe reactionin control animals are presumed to be due to sensitization.If the response is equivocal, rechallenge is recommended toconfirm the results from the first challenge.The outcome of the test is presented as the frequency of positivechallenge results in test and control animals.	The test article showed noevidenceofcausingdelayed dermalcontactsensitization in the guineapig.
Skin Irritation Test:Extraction Method	To evaluate the potentialskinirritation caused by test articlecontact with the skin surface ofrabbits and extrapolating the resultsto humans, but it does not establishthe actual risk of irritation.	When blank or negative control was used, calculate the primaryirritation score for the controls and subtract that score from thescore using the test material to obtain the primary irritationscore.	The test result showed thatthe response of the testarticleextractwascategorized as negligibleunder the test condition.
Acute Systemic Toxicity Test:Extraction Method	The test was designed to evaluatethe potential acute system toxicitycaused by test article contact withthe ICR mice and extrapolating theresults to humans.	Within the monitoring period (72 h), if the toxicosis responseof testing group is not greater than that of control group, thetesting sample is regarded as acceptable. In case that two ormore mice show the medium toxicosis symptom or die, thetesting sample is regarded as unacceptable. If any animalstreated with the sample show only slight signs of biologicalreactivity, and not more than one animal shows gross symptomsof biological reactivity or dies, repeat the testing using groupsof 10 animals. On the repeat test, if all 10 animals treated withthe sample show no scientifically meaningful biologicalreactivity above the vehicle control animals during theobservation period, the sample meets the requirements of thistest.	The test article showed noevidence of causing acutesystem toxicity in the ICRmice.

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Watertightness Test forDetection of Holes:Sampling procedures forinspection by attributes Part 1:Sampling schemes indexed byacceptance quality limit (AQL)for lot-by-lot inspection (ISO2859-1:1999)Standard Specification forNitrile Examination Gloves forMedical Application (ASTMD6319 - 19)Standard Test Method forDetection of Holes in MedicalGloves (ASTM D 5151-19)	The test was designed to validate theproperties of the test glove.Water tightness test for detection ofholes, physical dimensions andphysical properties were performedon the test glove to test itsproperties.The results showed each property ofthe test glove was acceptable underthis test condition.	Items: Water lack,Batch size: 35000Inspectional level: IAQL: 2.5Sample Demand: 125Criterion: ≤7	Number of Conforming:125 GloveNumber of Non-confirming: 0 Glove
Physical Dimensions Test:Sampling procedures forinspection by attributes Part 1:Sampling schemes indexed byacceptance quality limit (AQL)for lot-by-lot inspection (ISO2859-1:1999)Standard Specification forNitrile Examination Gloves forMedical Application (ASTMD6319 - 19)Standard Practice for Rubber—Measurement of Dimensions(ASTM D 3767-03(2014))		Items: Physical dimension testBatch size: 35000Inspectional Level: S-2AQL: 4.0Sample Demand: 13	The test result wasconsidered to beacceptable.
Determination of PhysicalProperties:Sampling procedures forinspection by attributes Part 1:Sampling schemes indexed byacceptance quality limit (AQL)		Items Before Aging After AcceleratedAging TensileStrength UltimateElongation TensileStrength UltimateElongation PhysicalRequirements ≥14MPa ≥500% ≥14MPa ≥400%															The test result wasconsidered to beacceptable.

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FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD

Inspection Level	S-2
AQL	4.0
Sample Size Code Letter	E
Batch Size	35000
Sample Demand	13
Number of Non-conforming	≤1	≤1	≤1	≤1
Powder-free Synthetic Exam3 sets of 2 gloves/batch, Average: 0.63mg/glove		Analyte: Residual PowderResult: 0.18mg/gloveThe results showed each property of the test glove was acceptable under this test condition.

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9. Clinical Test Conclusion

Clinical testing is not needed for this device.

10. 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.